CRYSTALLINE FORMS OF {2-[3-CYCLOHEXYL-3-(TRANS-4-PROPOXY-CYCLOHEXYL)-UREIDO]-THIAZOLE-5-YLSULFANYL}-ACETIC ACID AND THEIR USE

Abstract

This description relates to a) crystalline forms of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-ylsulfanyl}acetic acid ("Compound I"); b) pharmaceutical compositions comprising one or more crystalline forms of Compound I and, optionally, a pharmaceutically acceptable carrier; c) methods for treating a type of diabetes mellitus or other disorders by administering one or more crystalline forms of Compound I; and d) methods for preparing crystalline forms of Compound I.

Description

CRYSTALLINE FORMS OF {2-[3-CYCLOHEXYL-3-(TRANS-4-PROPOXYCYCLOHEXYL)-UREIDO]-THIAZOL-5-YLSULFANYL}ACETIC ACID AND THEIR USES FIELD OF INVENTION The present description relates to a) crystalline forms of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid (Compound I or API); b) pharmaceutical compositions comprising one or more crystalline forms of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid and, optionally, a pharmaceutically acceptable carrier; and c) methods for treating a type of diabetes mellitus and other disorders by administering one or more crystalline forms of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid to a subject in need thereof. BACKGROUND OF THE INVENTION Glucokinase (GK) is a key regulator of glucose homeostasis and acts as the physiological glucose sensor, changing its conformation, activity, and / or intracellular location in parallel with changes in glucose concentrations. GK has two main distinguishing characteristics that make it a good choice for blood glucose control. First, its expression is primarily limited to tissues that require glucose sensing (mainly the liver and pancreatic β cells). Second, GK is able to detect changes in serum glucose levels and modulate changes in glucose metabolism in the liver, which in turn regulate the balance between hepatic glucose production (HGP) and glucose uptake, and modulate changes in insulin secretion by beta cells.The concept of GK activation for the treatment of diabetes is attractive because it has proven to be effective and safe in normalizing blood glucose in animal models of type 1 and type 2 diabetes by a mechanism completely different from the action of antidiabetic therapies currently on the market. Although multiple small-molecule GK activators have been in clinical development, their initial therapeutic promise has been hampered by the occurrence of hypoglycemia, increased triglyceride (TG) concentrations, and loss of efficacy over time. These adverse events (AEs) were related to ongoing β-cell activation. Compound I, a hepatoselective agent, does not cause similar adverse effects. (Vella et al., Science Translational Medicine, January 16, 2019). Compound I is an orally administered, small-molecule, hepatic selective glucokinase activator that improves glycemic control and may not induce hypoglycemia, dyslipidemia, or pathological increases in liver glycogen and TG at therapeutically relevant doses. (Vella et al., Science Translational Medicine, January 16, 2019). ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t Not all compounds that are glucokinase activators possess characteristics that offer the greatest potential for becoming useful therapeutics. Some of these characteristics include high affinity for glucokinase, duration of glucokinase activation, oral bioavailability, tissue distribution, and stability (e.g., ability to be formulated or crystallized, shelf life). Favorable characteristics can lead to improved safety, tolerability, efficacy, therapeutic index, patient compliance, cost-effectiveness, ease of manufacture, and so on. In addition, the isolation and commercial-scale preparation of a crystalline form of Compound I and corresponding pharmaceutical formulations that have acceptable solid-state properties (including chemical stability, thermal stability, solubility, hygroscopicity and / or particle size), compound manufacturability (including yield, impurity rejection during crystallization, filtration properties, drying properties and milling properties) and formulation viability (including stability with respect to pressure or compression forces during tablet formation) present a number of challenges. Therefore, there is a current need for one or more crystalline forms of Compound I that have an acceptable balance of these properties and can be used in the preparation of pharmaceutically acceptable solid dosage forms. BRIEF DESCRIPTION OF THE INVENTION In one respect, the present description relates to a crystalline form of {2-[3-cyclohexyl3-(trans-4-propoxycyclohexyl)-ureido]-thazol-5-1-sulfanyl}-acetic acid. In one respect, the crystalline form is anhydrous. In another respect, the crystalline form is solvated. In one respect, the present description refers to the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid of Formula (I) MA / IZ / ZUZO / U1 l / 1 t (l), selected from the group consisting of: a) a crystalline form characterized by an XRPD pattern having peaks at 16.9 ± 0.2, 17.4 ± 0.2 and 20.1 ± 0.2 degrees two theta; b) a crystalline form characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2 and 17.8 ± 0.2 degrees two theta; c) a crystalline form characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 17.4 ± 0.2 and 21.6 ± 0.2 degrees two theta; d) a crystalline form characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2 and 26.4 ± 0.2 degrees two theta; e) a crystalline form characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2 and 18.9 ± 0.2 degrees two theta; f) a crystalline form characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2 and 16.8 ± 0.2 degrees two theta; g) a crystalline form characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2 and 21.9 ± 0.2 degrees two theta; h) a crystalline form characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2 and 8.5 ± 0.2 degrees two theta; i) a crystalline form characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 16.8 ± 0.2 and 18.8 ± 0.2 degrees two theta; and j) a crystalline form characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 17.4 ± 0.2 and 18.8 ± 0.2 degrees two theta. In one aspect, the present description refers to a crystalline form of {2-[3cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 16.9 ± 0.2, 17.4 ± 0.2 and 20.1 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thazol-5-ylsulfanyl}-acetic acid is characterized by an endothermic peak with onset at approximately 160 °C, as determined by DSC. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thazol-5-ylsulfanyl}-acetic acid is characterized by an IR pattern having peaks at 1099.7 ± 2.0, 1158.0 ±2.0 and 1313.2 ±2.0 cm1. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thazol-5-ylsulfanyl}-acetic acid is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 4. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid has a unit cell that is indexed as primitive monoclinic. In another aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid has a unit cell with a value of approximately 10.193 Å, a b-value of approximately 12.256 Å, and a c-value of approximately 18.991 Å. In another aspect, the crystalline form of {2-[3-cyclohexyl-3 MA / IZ / ZUZO / U1 l / 1 t (trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic has a unit cell with a volume of approximately 2370.9 Å3. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is Form A. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2 and 17.8 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by an endothermic peak with onset at approximately 166 °C, as determined by DSC. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid is characterized by an IR pattern having peaks at 1310.1 ± 2.0, 1514.4 ±2.0 and 1661.3 ±2.0 cm1. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 8. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid has a unit cell that is indexed as primitive monoclinic. In another respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid has a unit cell with a value of approximately 11.028 Å, a b value of approximately 11.933 Å, and a c value of approximately 18.737 Å. In another aspect, the crystalline form of {2-[3-cyclohexyl-3(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-11sulfanyl}-acetic acid has a unit cell with a volume of approximately 2449.0 Å3. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid is Form B. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 17.4 ± 0.2 and 21.6 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by an endothermic peak with onset at approximately 149 °C, as determined by DSC. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy¡-cyclohex¡l)ureido]-thiazol-5-¡lsulfan¡l}-acetic acid is a solvate of dichloromethane. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid has a unit cell that is indexed as monoclinic In another aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)-ureido]-thiazo-5-ylsulfanyl}-acetic acid has a unit cell with a value of approximately 5.541 Å, a b value of approximately 13.040 Å and a c value of approximately 40.818 Å. In another aspect, the crystalline form of {2-[3-cyclohexyl-3(trans-4-propoxycyclohexyl)-ureido]-thiazo-5-ylsulfanyl}-acetic acid has a unit cell with a volume of approximately 2947.6 Å3. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is Form C. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2 and 26.4 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by an endothermic peak with onset at approximately 147 °C, as determined by DSC. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 13. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid is Form D. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-1-sulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2 and 18.9 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by an endothermic peak with onset at approximately 171 °C, as determined by DSC. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is Form E. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-1-sulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2 and 16.8 ± 0.2 degrees two theta. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is Form F. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2 and 21.9 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl) acid MA / ΙΖ / ZUZO / U1 l / 1 t ureido]-thiazol-5-¡lsulfan¡l}-acetic acid is Form G. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2 and 8.5 ± 0.2 degrees two theta. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is Form H. In one aspect, the present description refers to a crystalline form of {2-[3cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 16.8 ± 0.2 and 18.8 ± 0.2 degrees two theta. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is Form I. In one aspect, the present description refers to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid, characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 17.4 ± 0.2 and 18.8 ± 0.2 degrees two theta. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-11sulfanyl}-acetic acid is characterized by an endothermic peak with onset at approximately 164 °C, as determined by DSC. In one respect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid is Form J. In some respects, the crystalline form is substantially free of other polymorphic forms. In some respects, the crystalline form has a polymorphic purity of at least approximately 80%. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid is selected from the group consisting of Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I, and Form J. In one aspect, the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)ureido]-thiazol-5-ylsulfanyl}-acetic acid is Form A. In some respects, the present description refers to a pharmaceutical composition comprising any one or more of the crystalline forms described above and a carrier, diluent, excipient, or pharmaceutically acceptable mixture thereof. In some respects, the present description refers to a method for treating a type of diabetes mellitus or other disorders, wherein the method comprises administering the pharmaceutical composition described above to a patient in need thereof. In some respects, the type of diabetes mellitus is type 1 diabetes. In some respects, the type of diabetes mellitus is type 2 diabetes. In some aspects, the pharmaceutical composition is administered orally. In some In some aspects, the pharmaceutical composition is administered as a tablet. In some aspects, the patient is administered up to approximately 2000 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid daily. In some respects, the present description provides methods for preparing a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-11sulfanilyl}acetic acid where the crystalline form is selected from the group consisting of Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I, and Form J. BRIEF DESCRIPTION OF THE FIGURES FIGURE 1 is a powder X-ray diffraction (XRPD) pattern corresponding to the crystalline A Form. FIGURE 2A is a differential scanning calorimetry (DSC) thermogram corresponding to the crystalline Form A. FIGURE 2B is a thermogravimetric analysis (TGA) thermogram corresponding to the crystalline Form A. FIGURE 3 is an infrared (IR) spectrum corresponding to the crystalline A Form. FIGURE 4 is a solid-state a13C NMR corresponding to the crystalline A Form. FIGURE 5 is an XRPD corresponding to the crystalline B form. FIGURE 6A is a DSC corresponding to the crystalline B form. FIGURE 6B is a TGA corresponding to the crystalline B form. FIGURE 7 is an IR spectrum corresponding to the crystalline B form. FIGURE 8 is a solid-state a13C NMR corresponding to the crystalline B form. FIGURE 9 is an XRPD corresponding to the crystalline C form. FIGURE 10A is a DSC corresponding to the crystalline C form. FIGURE 10B is a TGA corresponding to the crystalline C form. FIGURE 11 is an XRPD corresponding to the crystalline D form. FIGURE 12A is a DSC corresponding to the crystalline D-form. FIGURE 12B is a TGA corresponding to the crystalline D form. FIGURE 13 is a solid-state NMR at 13C corresponding to the crystalline D form. FIGURE 14 is an XRPD corresponding to the crystalline E Form. FIGURE 15A is a DSC corresponding to the crystalline E form. FIGURE 15B is a TGA corresponding to the crystalline E form. FIGURE 16 is an XRPD corresponding to the crystalline F form. FIGURE 17 is an XRPD corresponding to the crystalline G Form. FIGURE 18 is an XRPD corresponding to the crystalline H Form. FIGURE 19 is an XRPD corresponding to the crystalline Form I. FIGURE 20 is an XRPD corresponding to the crystalline J form. ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t FIGURE 21A is a DSC corresponding to the crystalline J form. FIGURE 21B is a TGA corresponding to the crystalline J form. DETAILED DESCRIPTION OF THE INVENTION I. Definitions To facilitate understanding of the description presented herein, a number of terms are defined below. In general, the nomenclature used herein and the laboratory processes in organic chemistry, medicinal chemistry, and pharmacology described herein are those well known and commonly employed in the field. Unless otherwise defined, all technical and scientific terms used herein generally have the same meaning as commonly understood by a person skilled in the art to which this description pertains. In this specification and the accompanying claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. The terms “a” (or “an”), as well as the terms “one or more” and “at least one,” may be used interchangeably herein. In some respects, the term “a” or “an” means single. In other respects, the term “a” or “an” includes two or more, or multiple. Furthermore, "and / or," where used herein, is to be taken as a specific description of each of the two specified characteristics or components with or without the other. Therefore, the term "and / or" as used in a phrase such as "A and / or B" herein is intended to include A and B, A or B, A (alone), and B (alone). Similarly, the term "and / or" as used in a phrase such as "A, B, and / or C" is intended to encompass each of the following: A, B, and C; A, B, or C; A or C; A or B; B or C; A and C; A and B; B and C; A (alone); B (alone); and C (alone). The term Compound I refers to the chemical compound {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid. The term subject refers to an animal, including, but not limited to, a primate (e.g., human), cow, sheep, goat, horse, dog, cat, rabbit, rat, or mouse. The terms subject and patient are used interchangeably herein when referring, for example, to a mammalian subject, such as a human. The terms treat, treats, and treatment are intended to include relieving or abolishing a disorder, disease, or condition, or one or more of the symptoms associated with the disorder, disease, or condition; or relieving the cause(s) of the disorder, disease, or condition itself. The terms “pharmaceutically acceptable carrier”, “pharmaceutically acceptable diluent” or “pharmaceutically acceptable excipient” refer to a pharmaceutically acceptable material, composition or vehicle, such as a liquid or solid filler agent, diluent, ML / E / ZuZo / uI í IL t excipient, solvent, or encapsulating material. In one respect, each component is pharmaceutically acceptable in the sense of being compatible with the other ingredients of a pharmaceutical formulation and suitable for use in contact with human and animal tissue or organs without excessive toxicity, irritation, allergic response, immunogenicity, or other problems or complications, proportionate to a reasonable benefit / risk ratio. See Remington: The Science and Practice of Pharmacy, 21st Edition, Lippincott Williams & Wilkins: Philadelphia, PA, 2005; Handbook of Pharmaceutical Excipient, 5th Edition, Rowe et al., Eds., The Pharmaceutical Press and the American Pharmaceutical Association: 2005; and Handbook of Pharmaceutical Additives, 3rd Edition, Ash and Ash Eds., Gower Publishing Company: 2007; Pharmaceutical Preformulation and Formulation, Gibson Ed., CRC Press LLC: Boca Raton, FL, 2004 (which is incorporated herein by reference). The terms “approximately” or “close to” signify an acceptable error for a particular value as determined by an expert in the technique, which depends in part on how the value is measured or determined. In some contexts, the term approximately or close to means within 1, 2, 3, or 4 standard deviations. In some modalities, the term approximately or close to means within 50%, 20%, 15%, 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, or 0.05% of a given value or interval. The terms active ingredient and active substance refer to a compound, administered alone or in combination with one or more pharmaceutically acceptable excipients, to a subject to treat, delay the onset of, or ameliorate one or more symptoms of a condition, disorder, or disease. As used herein, “active ingredient” and “active substance” may be an optically active isomer of a compound described herein. The term solvate or solvated refers to a compound provided herein, or a salt thereof, which also includes a stoichiometric or non-stoichiometric amount of solvent bound by non-covalent intermolecular forces. When the solvent is water, the solvate is a hydrate. When the solvent includes ethanol, the compound may be an ethanol solvate. The term polymorph, as used herein, refers to a crystalline form of a compound or a salt, hydrate, or solvate thereof, in a particular crystal-packed arrangement. All polymorphs have the same elemental composition. The term “crystalline,” as used herein, refers to a solid-state form consisting of an ordered arrangement of structural units. Different crystalline forms of the same compound, or a salt, hydrate, or solvate thereof, arise from different packing of molecules in the solid state, resulting in different crystal symmetries and / or unit-cell parameters. Different crystalline forms generally have different X-ray diffraction patterns, infrared spectra, melting points, densities, hardness, ML / E / ZuZo / uI í IL t crystalline form, optical and electrical properties, stability and solubility. See, for example, Remington's Pharmaceutical Sciences, 18th ed. Mack Publishing, Easton PA, 173 (1990); The United States Pharmacopeia, 23rd ed. 1843-1844 (1995) (incorporated herein by reference). Crystal forms are most commonly characterized by powder X-ray diffraction (XRPD). An XRPD reflection pattern (peaks, usually expressed in 2θ degrees) is commonly considered a fingerprint of a particular crystal form. The relative intensities of XRPD peaks can vary widely depending on, among other things, the sample preparation technique, crystal size distribution, filters, sample mounting process, and the specific instrument used. In some cases, new peaks may be observed, or existing peaks may disappear, depending on the instrument type or configuration. In some cases, any particular peak in an XRPD pattern may appear as a singlet, doublet, triplet, quartet, or multiple, depending on the instrument type or configurations, the instrument's sensitivity, the measurement conditions, and / or the purity of the crystal form.In some cases, any particular peak in an XRPD can appear in a symmetrical or asymmetrical form, for example, having a shoulder. Furthermore, instrument variation and other factors can affect the 2 theta values. A skilled practitioner who understands these variations is able to discriminate or determine the defining characteristics of a particular crystal form using XRPD, as well as using other known physicochemical techniques. The term anhydrate or anhydrous as applied to a compound refers to a solid state where the compound does not contain structural water within the crystal lattice. Unless the context requires otherwise, the terms understand, comprise, and that comprise are used on the basis and clear understanding that they are to be interpreted inclusively, rather than exclusively, and that the Applicant intends that each of those words be interpreted in that manner when interpreting this patent, including the claims below. For all the modalities described herein, maximum positional reproducibility is associated with the values ​​of degree 2 (XRPD), ppm (solid-state NMR at 13C), and cm⁻¹ (IR). Therefore, all peaks described herein are understood to have the stated value ± the peak positional reproducibility associated with each analytical technique. The maximum positional reproducibility of XRPD is ± 0.2 expressed in degree-2D. The peak positional reproducibility of 13C NMR is ± 0.2 ppm. The peak positional reproducibility of IR is ± 2 cm⁻¹. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art. ML / E / ZuZo / uI IL t technical to which the present description belongs. In case of disagreement, the present application, including the definitions, shall prevail. Unless the context requires otherwise, singular terms shall include plurals and plural terms shall include the singular. All publications, patents, and other references mentioned herein are incorporated by reference in their entirety for all purposes as if each individual publication or patent application were specifically and individually indicated to be incorporated by reference. II. Crystalline Forms In one aspect, the present description relates to a crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-1-sulfanyl}-acetic acid. In one aspect, the crystalline form is anhydrous as determined by 1H NMR. In another aspect, the crystalline form is solvated as determined by 1H NMR. In one respect, the present description refers to the crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-ylsulfanyl}-acetic acid of Formula (I) (I), selected from the group consisting of: a) a crystalline form characterized by an XRPD pattern having peaks at 16.9 ± 0.2, 17.4 ± 0.2 and 20.1 ± 0.2 degrees two theta; b) a crystalline form characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2 and 17.8 ± 0.2 degrees two theta; c) a crystalline form characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 17.4 ± 0.2 and 21.6 ± 0.2 degrees two theta; d) a crystalline form characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2 and 26.4 ± 0.2 degrees two theta; e) a crystalline form characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2 and 18.9 ± 0.2 degrees two theta; f) a crystalline form characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2 and 16.8 ± 0.2 degrees two theta; g) a crystalline form characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2 and 21.9 ± 0.2 degrees two theta; h) a crystalline form characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2 and 8.5 ± 0.2 degrees two theta; i) a crystalline form characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 16.8 ± 0.2 and 18.8 ± 0.2 degrees two theta; and j) a crystalline form characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 17.4 ± 0.2 and 18.8 ± 0.2 degrees two theta. A. Crystalline Form A In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 16.9 ± 0.2, 17.4 ± 0.2, and 20.1 ± 0.2 degrees two theta. In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 8.7 ± 0.2, 16.9 ± 0.2, 17.4 ± 0.2, and 20.1 ± 0.2 degrees two theta. In one aspect, the crystalline form of Compound I is characterized by an XRPD pattern substantially as shown in Figure 1. In one respect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 1 expressed in terms of relative intensities and degree 20: Table 1 IVIA / t / ZUZJ / UI / / I / Angle (Degree 20) Relative Intensity* (%) 8.7 ±0.2 83 9.3 ±0.2 18 11.3 ±0.2 13 12.1 ±0.2 83 12.3 ±0.2 49 13.0 ±0.2 26 14.4 ±0.2 76 15.7 ±0.2 11 16.9 ±0.2 100 17.4 ±0.2 95 18.7 ±0.2 48 18.9 ±0.2 43 19.2 ±0.2 68 20.1 ±0.2 99 20.8 ±0.2 71 21.4 ±0.2 39 21.7 ±0.2 63 22.2 ±0.2 20 22.7 ±0.2 48 23.0 ±0.2 36 23.5 ±0.2 33 23.7 ±0.2 27 23.9 ±0.2 31 24.3 ±0.2 28 25.9 ±0.2 20 27.2 ±0.2 30 27.6 ±0.2 17 28.3 ±0.2 13 28.5 ±0.2 12 ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t The relative intensities can change depending on the crystal size and morphology. In one aspect, the crystalline form of Compound I is characterized by an endothermic peak starting at approximately 160 °C, as determined by DSC. In one aspect, the crystalline form of Compound I is characterized by a DSC profile substantially as shown in Figure 2A. In one aspect, the crystalline form of Compound I is characterized by a TGA profile substantially as shown in Figure 2B. In one aspect, the crystalline form of Compound I is characterized by an IR pattern that has peaks at 1099.7 ± 2.0, 1158.0 ± 2.0, and 1313.2 ± 2.0 cm1. In one aspect, the crystalline form of Compound I is characterized by an IR pattern that has peaks at 1099.7 ± 2.0, 1158.0 ± 2.0, 1238.7 ± 2.0, and 1313.2 ± 2.0 cm1. In one aspect, the crystalline form of Compound I is characterized by the following IR peaks in Table 2. Table 2 Position (cm'1) Log (1 / R) 713.1 0.0120 723.0 0.0108 747.5 0.0083 777.1 0.0053 790.1 0.0063 807.0 0.0094 857.1 0.0116 893.9 0.0125 913.1 0.0114 941.2 0.0054 950.9 0.0054 1004.4 0.0108 1027.9 0.0114 1048.2 0.0122 1099.7 0.0316 1141.7 0.0152 1158.0 0.0284 1178.0 0.0127 1208.0 0.0146 1238.7 0.0256 1263.6 0.0134 1313.2 0.0440 1346.4 0.0247 1359.6 0.0234 1398.8 0.0132 1449.9 0.0131 1498.7 0.0136 1544.2 0.0282 1646.7 0.0265 1662.4 0.0402 1698.9 0.0109 1884.3 0.0034 2859.5 0.0067 2931.3 0.0109 3180.1 0.0016 3224.6 0.0019 In one respect, the crystalline form of Compound I is characterized by an IR pattern substantially as shown in FIGURE 3. In one respect, the crystalline form of Compound I is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 4. In one respect, the crystalline form is anhydrous as determined by 1H NMR. In one aspect, the crystalline form of Compound I has a unit cell that is classified as primitive monoclinic. In another aspect, the crystalline form of Compound I has a unit cell with a value of approximately 10.193 Å, a b value of approximately 12.256 Å, and a c value of approximately 18.991 Å. In yet another aspect, the crystalline form of Compound I has a unit cell with a volume of approximately 2370.9 ų. In one respect, the crystalline form of Compound I is Form A. B. Crystalline Form B In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2, and 17.8 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 5. In one aspect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 3 expressed in terms of relative intensities and 2Θ degree: Table 3 Angle (Degree 20) Relative Intensity * (%) 8.1 ±0.2 13 8.8 ±0.2 24 9.5 ±0.2 29 11 ±0.2 34 11.6 ±0.2 71 12.1 ±0.2 64 13.2 ±0.2 45 13.9 ±0.2 28 15.1 ±0.2 26 15.6 ±0.2 13 16.1 ±0.2 19 16.9 ±0.2 14 17.3 ±0.2 42 17.8 ±0.2 100 18.9 ±0.2 70 19.7 ±0.2 32 19.9 ±0.2 21 20.7 ±0.2 42 21.1 ±0.2 33 21.6 ±0.2 68 22.1 ±0.2 41 22.9 ± 0.2 35 23.3 ± 0.2 20 24.3 ± 0.2 20 24.8 ± 0.2 17 25.3 ± 0.2 19 26 ±0.2 13 26.6 ±0.2 13 27.6 ±0.2 10 28 ±0.2 15 28.7 ±0.2 15 29.3 ± 0.2 9 30.1 ±0.2 15 MA / E / ZUZo / U1 í ΙΛ t The relative intensities can change depending on the crystal size and morphology. In one aspect, the crystalline form of Compound I is characterized by an endothermic peak starting at approximately 166 °C, as determined by DSC. In one aspect, the crystalline form of Compound I is characterized by a DSC profile substantially as shown in Figure 6A. In one aspect, the crystalline form of Compound I is characterized by a TGA profile substantially as shown in Figure 6B. In one aspect, the crystalline form of Compound I is characterized by an IR pattern having peaks at 1310.1 ± 2.0, 1514.4 ± 2.0, and 1661.3 ± 2.0 cm⁻¹. In one aspect, the crystalline form of Compound I is characterized by an IR pattern having peaks at 1097.3 ± 2.0, 1310.1 ± 2.0, 1541.4 ± 2.0, and 1661.3 ± 2.0 cm⁻¹. In one aspect, the crystalline form of Compound I is characterized by the following IR peaks in Table 4. Table 4 Position (cm'1) Log(1 / R) 713.6 0.0109 726.3 0.0166 751.3 0.0080 775.2 0.0062 787.9 0.0099 807.3 0.0124 859.5 0.0120 894.7 0.0124 911.7 0.0146 942.3 0.0088 970.6 0.0077 999.7 0.0127 1018.6 0.0127 1049.1 0.0121 1097.3 0.0316 1122.7 0.0162 1137.9 0.0173 1159.8 0.0307 1183.7 0.0146 1208.6 0.0219 1239.5 0.0271 1265.0 0.0193 1310.1 0.0507 1356.7 0.0284 1399.3 0.0165 1451.7 0.0167 1500.3 0.0199 1541.4 0.0346 1661.3 0.0487 1697.0 0.0160 1886.9 0.0075 2858.8 0.0112 2932.8 0.0159 3184.1 0.0057 3229.2 0.0063 In one respect, the crystalline form of Compound I is characterized by an IR pattern substantially as shown in FIGURE 7. In one respect, the crystalline form of Compound I is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 8. In one respect, the crystalline form is anhydrous as determined by 1H NMR. In one aspect, the crystalline form of Compound I has a unit cell that is classified as primitive monoclinic. In another aspect, the crystalline form of Compound I has a unit cell with a value of approximately 11.028 Å, a b value of approximately 11.933 Å, and a c value of approximately 18.737 Å. In yet another aspect, the crystalline form of Compound I has a unit cell with a volume of approximately 2449.0 ų. In one respect, the crystalline form of Compound I is Form B. C. Crystalline Form C In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 17.4 ± 0.2, and 21.6 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 9. In one respect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 5 expressed in terms of relative intensities and degree 20: Table 5 ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t Angle (Degree 20) Relative Intensity * (%) 4.3 ±0.2 100 7.1 ±0.2 20 8 ±0.2 71 9.4 ±0.2 9 11 ±0.2 14 13 ±0.2 8 13.6 ±0.2 11 13.8 ±0.2 7 14.3 ±0.2 6 14.7 ±0.2 14 15.1 ±0.2 9 16 ±0.2 39 16.1 ±0.2 15 16.4 ±0.2 10 16.7 ±0.2 28 17.4 ±0.2 73 17.8 ±0.2 77 18 ±0.2 50 18.4 ±0.2 9 18.7 ±0.2 20 18.8 ±0.2 13 19.2 ±0.2 8 19.7 ±0.2 20 20.3 ±0.2 18 20.5 ±0.2 63 20.7 ±0.2 32 20.9 ±0.2 19 21.1 ±0.2 96 21.6 ±0.2 88 22.2 ± 0.2 48 22.8 ± 0.2 11 23 ± 0.2 10 23.5 ± 0.2 15 24 ± 0.2 11 24.3 ± 0.2 12 24.5 ± 0.2 8 25 ± 0.2 8 25.1 ± 0.2 12 25.6 ± 0.2 11 25.7 ± 0.2 10 26 ± 0.2 67 26.3 ± 0.2 37 26.5 ± 0.2 29 26.7 ± 0.2 36 27 ± 0.2 11 27.3 ± 0.2 13 28.1 ± 0.2 10 28.5 ± 0.2 7 28.7 ± 0.2 7 29.3 ± 0.2 8 The relative intensities can change depending on the crystal size and morphology. In one aspect, the crystalline form of Compound I is characterized by an endothermic peak starting at approximately 149 °C, as determined by DSC. In one aspect, the crystalline form of Compound I is characterized by a DSC profile substantially as shown in Figure 10A. In one aspect, the crystalline form of Compound I is characterized by a TGA profile substantially as shown in Figure 10B. In one respect, the crystalline form is a solvate as determined by 1H NMR. In one respect, the crystalline form of Compound I is a dichloromethane solvate. In one aspect, the crystalline form of Compound I has a unit cell that is classified as primitive monoclinic. In another aspect, the crystalline form of Compound I has a unit cell with a value of approximately 5.541 Å, a b value of approximately 13.040 Å, and a c value of approximately 40.818 Å. In yet another aspect, the crystalline form of Compound I has a unit cell with a volume of approximately 2947.6 ų. In one respect, the crystalline form of Compound I is Form C. D. Crystalline Form D In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2, and 26.4 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 11. In one aspect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 6 expressed in terms of relative intensities and degree 20: Table 6 ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t Angle (Degree 20) Relative Intensity * (%) 5.3 ±0.2 66 7.4 ±0.2 8 8.7 ±0.2 100 10.5 ±0.2 3 12.6 ±0.2 11 13.8 ±0.2 32 14.8 ±0.2 25 14.9 ±0.2 24 16.0 ±0.2 22 16.0 ±0.2 21 16.8 ±0.2 11 17.4 ±0.2 31 17.6 ±0.2 21 17.9 ±0.2 13 18.2 ±0.2 34 19.1 ±0.2 23 19.2 ±0.2 23 19.8 ±0.2 23 20.3 ±0.2 9 21.1 ±0.2 28 21.3 ±0.2 27 21.4 ±0.2 19 21.8 ±0.2 28 22.6 ±0.2 11 23.3 ±0.2 7 23.7 ±0.2 10 24.7 ±0.2 5 25.0 ±0.2 4 25.5 ±0.2 5 26.4 ±0.2 43 26.9 ±0.2 22 27.5 ±0.2 6 28.4 ±0.2 7 29.0 ±0.2 3 29.5 ±0.2 3 30.1 ±0.2 4 The relative intensities can change depending on the crystal size and morphology. In one aspect, the crystalline form of Compound I is characterized by an endothermic peak starting at approximately 147 °C, as determined by DSC. In one aspect, the crystalline form of Compound I is characterized by a DSC profile substantially as shown in Figure 12A. In one aspect, the crystalline form of Compound I is ML / E / ZuZo / uI í IL t is characterized by a TGA profile substantially as shown in FIGURE 12B. In one respect, the crystalline form of Compound I is characterized by a solid-state a13C NMR substantially similar to FIGURE 13. In one respect, the crystalline form of Compound I is Form D. E. Crystalline Form E In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2, and 18.9 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 14. In one aspect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 7 expressed in terms of relative intensities and degree 20: Table 7 ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t Angle (Degree 20) Relative Intensity * (%) 5.8 ±0.2 100 8.6 ±0.2 4 9.5 ±0.2 4 11.6 ±0.2 9 12.8 ±0.2 8 14.7 ±0.2 9 16.9 ±0.2 10 17.5 ±0.2 14 17.9 ±0.2 49 18.9 ±0.2 34 20.7 ±0.2 20 22.1 ±0.2 9 23.1 ±0.2 5 24.3 ±0.2 8 26.1 ±0.2 10 26.7 ±0.2 11 28.2 ±0.2 6 28.5 ±0.2 6 30.0 ±0.2 7 The relative intensities can change depending on the crystal size and morphology. In one aspect, the crystalline form of Compound I is characterized by an endothermic peak starting at approximately 171 °C, as determined by DSC. In one aspect, the crystalline form of Compound I is characterized by a DSC profile substantially as shown in Figure 15A. In one aspect, the crystalline form of Compound I is characterized by a TGA profile substantially as shown in Figure 15B. In one respect, the crystalline form of Compound I is Form E. F. Crystalline Form F In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2, and 16.8 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 16. In one aspect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 8 expressed in terms of relative intensities and degree 20: Table 8 Angle (Degree 20) Relative Intensity * (%) 3.4 ±0.2 76 3.8 ±0.2 100 6.8 ±0.2 43 7.4 ±0.2 30 8.3 ±0.2 53 9.5 ±0.2 89 10.0 ±0.2 31 13.7 ±0.2 40 14.9 ±0.2 53 15.8 ±0.2 59 16.8 ±0.2 80 17.1 ±0.2 63 17.5 ±0.2 62 17.9 ±0.2 72 18.1 ±0.2 60 18.4 ±0.2 54 19.1 ±0.2 60 19.6 ±0.2 54 20.0 ±0.2 67 20.6 ±0.2 65 20.9 ±0.2 58 21.2 ±0.2 67 21.7 ±0.2 64 22.4 ±0.2 45 23.3 ±0.2 34 24.0 ±0.2 32 25.5 ±0.2 37 26.1 ±0.2 29 27.0 ±0.2 47 ML / E / ZuZo / uΊ 11 \l *Relative intensities may change depending on crystal size and morphology. In one respect, the crystalline form of Compound I is Form F. G. Crystalline Form G In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2, and 21.9 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 17. In one aspect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 9 expressed in terms of relative intensities and 2Θ degree: Table 9 Angle (Degree 29) Relative Intensity * (%) 3.4 ±0.2 100 4.7 ±0.2 30 4.9 ±0.2 23 8.3 ±0.2 23 8.4 ±0.2 22 8.7 ±0.2 24 10.3 ±0.2 19 14.7 ±0.2 30 21.2 ±0.2 62 21.9 ±0.2 59 22.4 ±0.2 55 27.6 ±0.2 45 ΜΛ / Ε / ΖυΖο / υΊ ί ΙΛ t The relative intensities can change depending on the crystal size and morphology. In one respect, the crystalline form of Compound I is Form G. H. Crystalline Form H In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2, and 8.5 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 18. In one respect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 10 expressed in terms of relative intensities and degree 20: Table 10 Angle (Degree 20) Relative Intensity * (%) 3.8 ±0.2 100 5.3 ±0.2 24 7.2 ±0.2 21 7.7 ±0.2 23 8.5 ±0.2 26 9.0 ±0.2 24 10.1 ±0.2 15 10.8 ±0.2 14 12.0 ±0.2 14 13.8 ±0.2 11 15.7 ±0.2 16 15.9 ±0.2 24 16.6 ±0.2 13 17.2 ±0.2 17 17.7 ±0.2 16 18.5 ±0.2 14 19.0 ±0.2 11 19.3 ±0.2 11 19.8 ±0.2 12 20.2 ±0.2 18 21.1 ±0.2 16 21.9 ±0.2 20 22.5 ±0.2 15 23.1 ±0.2 15 23.6 ±0.2 12 25.0 ±0.2 9 25.7 ±0.2 8 27.2 ±0.2 19 27.7 ±0.2 10 ML / E / ZuZo / uI ί IL t *Relative intensities may change depending on crystal size and morphology. In one respect, the crystalline form of Compound I is the H Form. I. Crystalline Form I In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 16.8 ± 0.2, and 18.8 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 19. In one respect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 11 expressed in terms of relative intensities and degree 20: Table 11 Angle (Degree 20) Relative Intensity * (%) 5.0 ±0.2 27 100 9.0 ±0.2 10 11.8 ±0.2 11 12.8 ±0.2 10 13.8 ±0.2 12 13.9 ±0.2 12 15.9 ±0.2 27 16.2 ±0.2 23 16.8 ±0.2 34 17.4 ±0.2 24 18.0 ±0.2 24 18.8 ±0.2 41 19.1 ±0.2 35 19.6 ±0.2 22 20.0 ±0.2 24 20.8 ±0.2 16 22.5 ± 0.2 12 22.9 ± 0.2 12 24.0 ±0.2 12 25.6 ±0.2 11 26.4 ±0.2 9 27.4 ±0.2 6 27.9 ±0.2 7 28.1 ±0.2 8 28.7 ±0.2 6 The relative intensities can change depending on the crystal size and morphology. In one respect, the crystalline form of Compound I is Form I. J. Crystalline Form J In one aspect, the present description relates to a crystalline form of Compound I, characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 17.4 ± 0.2, and 18.8 ± 0.2 degrees two theta. In one respect, the crystalline form of Compound I is characterized by a substantially XRPD pattern as shown in FIGURE 20. In one aspect, the crystalline form of Compound I is characterized by an endothermic peak starting at approximately 164 °C, as determined by DSC. In one aspect, the crystalline form of Compound I is characterized by a DSC profile substantially as shown in Figure 21A. In one aspect, the crystalline form of Compound I is characterized by a TGA profile substantially as shown in Figure 21B. In one aspect, the crystalline form of Compound I is characterized by the following XRPD pattern in Table 12 expressed in terms of relative intensities and degree 29: Table 12 ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t Angle (Degree 20) Relative Intensity * (%) 5.9 ±0.20 40 8.2 ±0.20 16 9.4 ±0.20 13 11.5 ±0.20 36 12.7 ±0.20 42 14.7 ±0.20 17 15.0 ±0.20 19 15.4 ±0.20 14 16.2 ±0.20 25 17.4 ±0.20 43 18.3 ±0.20 93 18.8 ±0.20 100 20.0 ±0.20 41 20.3 ±0.20 36 20.9 ±0.20 20 22.0 ±0.20 20 22.7 ±0.20 20 23.0 ±0.20 18 23.6 ±0.20 20 24.0 ±0.20 24 24.3 ±0.20 22 25.4 ±0.20 24 25.7 ±0.20 27 26.1 ±0.20 26 26.7 ±0.20 20 The relative intensities can change depending on the crystal size and morphology. In one respect, the crystalline form of Compound I is Form J. In some respects, any of the crystalline forms described above is substantially free of other polymorphic forms. In some respects, the crystalline form has a polymorphic purity of at least approximately 80%. In some respects, the crystalline form has a polymorphic purity of at least approximately 80%, at least approximately 85%, at least approximately 86%, at least approximately 87%, at least approximately 88%, at least approximately 89%, at least approximately 90%, at least approximately 91%, at least approximately 92%, at least approximately 93%, at least approximately 94%, at least approximately 95%, at least approximately 96%, at least approximately 97%, at least approximately 98%, or at least approximately 99%. In one respect, the crystalline form of Compound I is selected from the group consisting of Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I, and Form J. In one respect, the crystalline form of Compound I is Form A. In one aspect, the crystalline form of Compound I is a mixture of two or more forms selected from the group consisting of Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I, and Form J. In another aspect, the crystalline form of Compound I is a mixture of two or more forms selected from the group consisting of Form A, Form B, and Form C. In yet another aspect, the crystalline form of Compound I is a mixture of Form A and Form B, where Form B is the major form and Form A is the minor form. In some respects, the present description provides a method for preparing a crystalline form of Compound I, wherein the crystalline form is selected from the group consisting of Form A, Form B, Form C, Form D, Form E, Form F, Form G, Form H, Form I, and Form J. One or more methods for preparing Forms A and J are provided herein in the Experimental Section. III. Pharmaceutical Composition This description refers to a pharmaceutical composition comprising the crystalline form of any of the AJ Forms of Compound I and a pharmaceutically acceptable carrier, diluent or excipients, or a mixture thereof. In one respect, the pharmaceutical composition comprises the crystalline form of any of the AJ Forms of Compound I. MA / IZ / ZUZO / U1 l / 1 t Pharmaceutical compositions comprising the crystalline form of any of the AJ Forms of Compound I may be in a form suitable for oral use, for example, as tablets, lozenges, coated tablets, dispersible powders or granules, or hard or soft capsules. Compositions intended for oral use may be prepared according to any known method, and these compositions may contain one or more agents selected from the group consisting of sweetening agents, flavoring agents, coloring agents, and preservatives in order to provide pharmaceutically appealing and palatable preparations. In some respects, the pharmaceutical composition can be administered to subjects via oral, parenteral (such as subcutaneous, intravenous, intramuscular, intrasternal and infusion techniques), rectal, intranasal, topical or transdermal (e.g., via the use of a patch) routes. In one aspect, the pharmaceutical composition comprises approximately 100 mg to approximately 1500 mg, approximately 100 mg to approximately 1400 mg, approximately 100 mg to approximately 1300 mg, approximately 100 mg to approximately 1200 mg, approximately 100 mg to approximately 1100 mg, approximately 100 mg to approximately 1000 mg, approximately 100 mg to approximately 900 mg, approximately 100 mg to approximately 800 mg, approximately 100 mg to approximately 700 mg, approximately 100 mg to approximately 600 mg, approximately 100 mg to approximately 500 mg, approximately 100 mg to approximately 400 mg, approximately 100 mg to approximately 300 mg, approximately 100 mg to approximately 200 mg, or approximately 100 mg to approximately 150 mg of the crystalline form of any of the AJ Forms of Compound I described in the present.In one aspect, the pharmaceutical composition comprises approximately 100 mg, approximately 200 mg, approximately 300 mg, approximately 400 mg, approximately 500 mg, approximately 600 mg, approximately 700 mg, approximately 800 mg, approximately 900 mg, approximately 1000 mg, approximately 1100 mg, approximately 1200 mg, approximately 1300 mg, approximately 1400 mg or approximately 1500 mg of the crystalline form of any of the AJ Forms of Compound I described herein. In some respects, the pharmaceutical composition is an oral tablet. In some respects, the oral tablet comprises approximately 0.1 mg to 2000 mg of the crystalline form of any of the AJ Forms of 2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)ureido]thiazol-5-ylsulfanyl]acetic acid. In some respects, the oral tablet comprises approximately 1 mg to approximately 2000 mg of the crystalline form of any of the AJ Forms of ML / E / ZyZo / uI 11 \l Compound I. In some respects, the oral tablet comprises approximately 1 mg to approximately 1000 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises approximately 100 mg to approximately 800 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises approximately 50 mg to approximately 400 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises approximately 100 mg to approximately 400 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises approximately 100 mg to approximately 300 mg of the crystalline form of any of the AJ Forms of Compound I.In some respects, the oral tablet comprises approximately 500 mg to approximately 1000 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises approximately 0.1 mg, approximately 0.5 mg, approximately 1 mg, approximately 5 mg, approximately 10 mg, approximately 20 mg, approximately 30 mg, approximately 40 mg, approximately 50 mg, approximately 60 mg. MA / E / ZUZo / U1 11 \l approximately 70 mg, approximately 80 mg, approximately 90 mg, approximately 100 mg, approximately 125 mg, approximately 150 mg, approximately 175 mg, approximately 200 mg, approximately 225 mg, approximately 250 mg, approximately 275 mg, approximately 275 mg, approximately 300 mg, approximately 325 mg, approximately 350 mg, approximately 375 mg, approximately 400 mg, approximately 425 mg, approximately 450 mg, approximately 475 mg, approximately 500 mg, approximately 550 mg, approximately 600 mg, approximately 650 mg, approximately 700 mg, approximately 750 mg, approximately 800 mg, approximately 850 mg, approximately 900 mg, approximately 1000 mg, approximately 1050 mg, approximately 1100 mg, approximately 1150 mg, approximately 1200 mg, approximately 1250 mg, approximately 1300 mg, approximately 1350 mg, approximately 1400 mg, approximately 1450 mg, approximately 1500 mg, approximately 1550 mg,approximately 1600 mg, approximately 1650 mg, approximately 1700 mg, approximately 1750 mg, approximately 1800 mg, approximately 1850 mg, approximately 1900 mg, approximately 1950 mg or approximately 2000 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises 800 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises 400 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises 300 mg of the crystalline form of any of the AJ Forms of Compound I. In some respects, the oral tablet comprises approximately 200 mg of the crystalline form of any of the AJ Forms of Compound I. IV. Treatment Method In some respects, the present description relates to a method for treating a type of diabetes mellitus, wherein the method comprises administering the pharmaceutical composition described above to a patient in need thereof. The method may comprise administering a pharmaceutical composition comprising a therapeutically effective amount of the crystalline form of any of the AJ Forms of Compound I. In some respects, the type of diabetes mellitus is type 1 diabetes. In some respects, the type of diabetes mellitus is type 2 diabetes. In some respects, the type of diabetes is one or two types of diabetes, type 1 and type 2. In some respects, the patient is being treated with insulin therapy. In some respects, insulin therapy is a continuous insulin infusion. In some respects, insulin therapy is a continuous subcutaneous insulin infusion. In some respects, insulin therapy is multiple daily insulin injections. In another aspect, the present description provides a method for the treatment of conditions or diseases mediated by glucokinase deficiency, or conditions that benefit from an increase in glucokinase activity, comprising administering to a subject in need thereof a compound or pharmaceutical composition of the present description. In another aspect, the present description provides a method for the treatment of metabolic disorders, for lowering blood glucose, for the treatment of hyperglycemia, for the treatment of hypoglycemia, for the treatment of impaired glucose tolerance (IGT), for the treatment of syndrome X, for the treatment of impaired fasting glucose (IFG), for delaying the progression of impaired glucose tolerance (IGT) to type 2 diabetes, for delaying the progression of non-insulin-dependent type 2 diabetes to type 2 diabetes, for the treatment of dyslipidemia, for the treatment of hyperlipidemia, for the treatment of hypertension, for decreasing food intake, for regulating appetite, for the treatment of obesity, for regulating eating behavior, or for improving enteroincretin secretion.which includes administering to a subject in need of this treatment or a pharmaceutical composition of the present description. In another aspect, the present description provides a method for preserving beta cell mass and function comprising administering to a subject in need of such treatment a compound or pharmaceutical composition of the present description. ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t In another aspect, the present description provides a method for preserving and / or increasing beta cell mass and function in a subject who has undergone pancreatic islet transplantation, comprising administering to a subject in need of such treatment a compound or pharmaceutical composition of the present description. In another aspect, the present description provides a method for improving liver function and / or survival in subjects undergoing liver transplantation, comprising administering a compound or pharmaceutical composition of the present description to a subject in need of such treatment. In a further aspect, the administration occurs before, during, or after transplantation, or any combination thereof. In another aspect, the present description provides a method for preventing diabetic ketoacidosis or reducing the occurrence of diabetic ketoacidosis events in a subject comprising administering to a subject in need of this treatment a compound or pharmaceutical composition of the present description. Depending on the condition, disorder, or disease being treated and the patient's condition, the pharmaceutical compositions provided herein may be administered orally, parenterally (e.g., intramuscular, intraperitoneal, intravenous, or intra-arterial (e.g., via catheter), intracisternal injection or infusion, subcutaneous injection, or implant), by inhalation, nasally, vaginally, rectally, sublingually, and / or topically (e.g., transdermal or local), and may be formulated alone or in combination in a suitable dosage unit with a pharmaceutically acceptable vehicle, carrier, diluent, excipient, or a mixture thereof, appropriate for each route of administration. In one aspect, the pharmaceutical composition is administered orally. For oral administration, the pharmaceutical compositions provided herein may be supplied in solid, semisolid, or liquid dosage forms. As used herein, oral administration also includes buccal, lingual, and sublingual administration. Suitable oral dosage forms include, but are not limited to, tablets, capsules, pills, lozenges, coated tablets, pastilles, powder suspensions, granules, medicated chewing gum, granules, bulk powders, effervescent or non-effervescent granules or powders, solutions, emulsions, suspensions (e.g., aqueous or oil-based suspensions), wafers, powders, elixirs, syrups, boluses, electuaries, or pastes. In one aspect, the pharmaceutical composition is administered as a tablet. The dose may be in the form of one, two, three, four, five, six, or more subdoses administered at appropriate intervals throughout the day. The dose or subdose may be administered in the form of dosage units containing approximately 1 mg to approximately 2000 mg, approximately 10 mg to approximately 2000 mg, approximately 100 mg to approximately 1500 mg, approximately 200 mg to ML / t / ZUZÓ / UΊ í IL t approximately 1500 mg, from approximately 300 mg to approximately 1500 mg, from approximately 400 mg to approximately 1500 mg, from approximately 500 mg to approximately 1500 mg, from approximately 500 mg to approximately 1000 mg, or from approximately 500 mg to approximately 800 mg of the crystalline form of any of the AJ Forms per dosage unit. For example, the dose or subdose may be administered in the form of dosage units containing approximately 100 mg, approximately 200 mg, approximately 300 mg, approximately 400 mg, approximately 500 mg, approximately 600 mg, approximately 700 mg, approximately 800 mg, approximately 900 mg, approximately 1000 mg, approximately 1100 mg, approximately 1200 mg, approximately 1300 mg, approximately 1400 mg, approximately 1500 mg, approximately 1600 mg, approximately 1700 mg, approximately 1800 mg, approximately 1900 mg or approximately 2000 mg of the crystalline form of any of the AJ Forms described herein. In some aspects, the patient is administered approximately 0.1 mg to approximately 2000 mg of the crystalline form of any of the AJ Forms of Compound I daily. In some aspects, the patient is administered approximately 1 mg to approximately 2000 mg of the crystalline form of any of the AJ Forms of Compound I daily. In some aspects, the patient is administered approximately 100 mg to approximately 800 mg of the crystalline form of any of the AJ Forms of Compound I daily. In some aspects, the patient is administered approximately 50 mg to approximately 400 mg of the crystalline form of any of the AJ Forms of Compound I daily. In some aspects, the patient is administered approximately 100 mg to approximately 400 mg of the crystalline form of any of the AJ Forms of Compound I daily.In some aspects, the patient is administered approximately 100 mg to approximately 300 mg of the crystalline form of any of the AJ Forms of Compound I daily. In some aspects, the patient is administered approximately 500 mg to approximately 1000 mg of the crystalline form of any of the AJ Forms of Compound I daily. In some aspects, the patient is administered approximately 0.1 mg, approximately 0.5 mg, approximately 1 mg, approximately 5 mg, approximately 10 mg, approximately 20 mg, approximately 30 mg, approximately 40 mg, approximately 50 mg, approximately 60 mg, approximately 70 mg, approximately 80 mg, approximately 90 mg, approximately 100 mg, approximately 125 mg, approximately 150 mg, approximately 175 mg, approximately 200 mg, approximately 225 mg, approximately 250 mg, approximately 275 mg, approximately 300 mg. approximately 325 mg, approximately 350 mg, approximately 375 mg approximately 400 mg, approximately 425 mg, approximately 450 mg approximately 500 mg, approximately 550 mg, approximately 1000 mg approximately 1050 mg, approximately 1100 mg, approximately 1150 mg approximately 1200 mg, approximately 1250 mg, approximately 1300 mg approximately 1350 mg, approximately 1400 mg, approximately 1450 mg approximately 1500 mg, approximately 1550 mg, approximately 1600 mg approximately 1650 mg, approximately 1700 mg, approximately 1750 mg approximately 1800 mg, approximately 1850 mg, approximately 1900 mg approximately 1950 mg, or approximately 2000 mg of the crystalline form of either ML / E / ZuZo / uI í IL t of the AJ Forms of Compound I once a day. In some aspects, the patient is administered approximately 800 mg of the crystalline form of any of the AJ Forms of Compound I once a day. In some aspects, the patient is administered approximately 400 mg of the crystalline form of any of the AJ Forms of Compound I once a day. In some aspects, the patient is administered approximately 300 mg of the crystalline form of any of the AJ Forms of Compound I once a day. In some aspects, the patient is administered approximately 200 mg of the crystalline form of any of the AJ Forms of Compound I once a day. In some aspects, the patient is administered approximately 100 mg of the crystalline form of any of the AJ Forms of Compound I once a day. EXAMPLES A. Abbreviations and Acronyms DSC Differential Scanning Calorimetry DVS Dynamic Vapor Sorption HSM Hot Phase Microscopy NMR Nuclear Magnetic Resonance Spectroscopy PLM Polarized Light Microscopy TGA Thermogravimetric Analysis XRPD Powder X-ray Diffraction CC Shock Cooling FC Rapid Cooling FE Rapid Evaporation SAS Solvent / Antisolvent SE Slow Evaporation ACN Acetonitrile 1-BuOH 1-Butanol 2-BuOH 2-Butanol BuOAc Butyl acetate iBuOAc Isobutyl acetate t-BuOAc tert-Butyl acetate CHCl3 Chloroform DCE 1,2-Dichloroethane DCM Dichloromethane DMF Dimethylformamide DMSO Dimethyl sulfoxide EtOAc Ethyl acetate EtOH Ethanol HFIPA Hexafluoroisopropanol Hexafluoro-2-propanol H2O Water IPA Isopropyl alcohol 2-propanol MEK Methyl ethyl ketone Butanone MeOH Methanol MIBK Methyl isobutyl ketone MTBE tert-Butyl methyl ether NMP N-Methyl-2-pyrrolidone iPrOAc Isopropyl acetate 1-PrOH 1-Propanol TFE 2,2,2-Trifluoroethanol THF Tetrahydrofuran agg· Aggregates anh. Anhydrous B / E Birefringence and extinction d Day(s) endo Endothermy h hour(s) min minute(s) NA Numerical aperture HR Relative humidity TA Ambient temperature / ambient temperature UM Unknown morphology v / v Volume / volume c / With P Weight ΜΛ / Ε / ΖυΖο / υΊ ί ΙΛ t B. Experimental Methods Example 1: Stable Form and Hydration Analysis through Suspension Trituration Experiments Suspension crushing experiments target stable forms, including solvates and stable hydrates. The suspension trituration experiments were carried out by stirring Compound I solids in specified solvents and solvent mixtures at various temperatures for 7 days (elevated temperature) or 14–18 days (ambient and sub-ambient temperature). A summary of the experimental conditions and results is detailed in Table 13. Table 13 Solvent (v / v) Condition * Observations XRPD Result CHCl3 2-8 °C, 18 d white suspension, particles and aggregates of B / E, UM Form H dioxane / H2O (85 / 15) 2-8 °C, 18 d white suspension, particles and aggregates of B / E, UM Form A HFIPA / MTBE (50 / 50) 2-8 °C, 18 d white suspension, particles and aggregates of B / E, UM Form A TFE / H2O (87 / 13) 2-8 °C, 18 d white suspension, particles and aggregates of B / E, UM Form A THF / H2O (93 / 7) 2-8 °C, 18 d white suspension, particles and aggregates of B / E, UM Form A acetone TA, 14 d yellow suspension, particles and aggregates of B / E, UM Form A 2-BuOH TA, 14 d white suspension, particles and aggregates of B / E, UM Form A DCM TA, 14 d brown suspension, particles and aggregates of B / E, UM Form C, with additional peaks at 2.8 ° and 8.6 ° 0 26 DMSO / iPrOAc (5 / 95) TA, 14 d white suspension, particles and aggregates of B / E, UM Form A dioxane TA, 14 d white suspension, particles and aggregates of B / E, UM Form A EtOH TA, 14 d white suspension, particles and aggregates of B / E, UM Form A MEK TA, 14 d white suspension, particles and aggregates of B / E, UM Form A MeOH TA, 14 d white suspension, particles and B / E aggregates, UM Form A NMP:nitromethane (20 / 80) TA, 14 d white suspension, particles and aggregates of B / E, UM Form A 1-PrOH TA, 14 d white suspension, particles and aggregates of B / E, UM Form A TFE TA, 14 d white suspension, particles and aggregates of B / E, UM Form A THF TA, 14 d white suspension, particles and aggregates of B / E, UM Form A ΜΛ / Ε / ΖυΖο / υΊ ί ΙΛ I ACN anh. 55 °C, 7 d white suspension, particles and aggregates of B / E, UM Form A DCE anh. 55 °C, 7 d light yellow suspension, particles and aggregates of B / E, UM Form A EtOAc anh. 55 °C, 7 d white suspension, particles and aggregates of B / E, UM Form A EtOH anh. 55 °C, 7 d brown suspension, particles and aggregates of B / E, UM decomposed toluene anhydrous 55 °C, 7 d white suspension, particles and aggregates of B / E, UM Form A *: Temperatures are approximate. Example 2: Polymorphic Analysis IVIA / t / ZUZJ / UI / / I / Unless otherwise noted, the solids from Compound I were used as the starting material. The materials produced in the study were used for selected experiments. Method a: Evaporation Experiments The starting material solutions were allowed to partially evaporate or evaporate to dryness at room or elevated temperature from open vials for rapid evaporation (FE) or from foil-covered vials with pinholes for slow evaporation (SE). Prior to evaporation, the solutions were filtered at room or elevated temperature using 0.2 µm nylon filters. Method b: Cooling Experiments Starting material solutions were prepared in specified solvents at elevated temperatures using a hot plate for heating. These were typically filtered while hot through a 0.2 µm nylon filter into heated receiving vials. The vials were then rapidly transferred to a subambient temperature bath (typically dry ice / acetone) for shock cooling (SC), removed from the hot location for rapid cooling (FC), or the heat was turned off to allow slow cooling (SC). If solids precipitated, they were cold-isolated by vacuum filtration. If the solution remained clear, the sample was maintained at subambient temperatures or further crystallization techniques were applied. Method c: Suspension Experiments The solids were suspended in specified solvents. The suspensions were then stirred at room or fixed temperature. After a given amount of time, the solids were isolated. Method d: Solvent / antisolvent precipitation The starting material sclerocicnes were prepared at room or elevated temperature and filtered using 0.2 µm nylon filters. They were then mixed with appropriate antisolvents at elevated temperature. If no solids were observed, the samples were cooled to ambient or sub-ambient temperatures or other crystallization techniques were applied. Polymorph analysis was performed using various solvent-based techniques, including evaporation, cooling, suspension, solvent / antisolvent addition, and combinations of these techniques. Detailed experimental conditions, observations, and XRPD results are summarized in Table 14. Table 14 ΜΛ / Ε / ΖυΖο / υΊ í ΙΛ t Solvent (v / v) Conditions * XRPD Result Acetone 1. SE then FE Form A + Form B, with an additional peak at 5.9 0 20 1. FC (55 °C to an ice / water bath) 2. is kept at -10— 25 °C for 4 days Form B + Form A lower, with additional peaks at 5.9° and 18.3° 20 suspension, seeded with 8065-30-03, TA for 7 d Form A Acetone anh. 1. CC (55 °C to -78 °C) 2. Inside wall of vial scored for nucleation, maintain at -10–25 °C for 3 days Form B + Minor Form A acetone / H₂O (68 / 32) 1. SAS, API solution in acetone in cold H₂O 2. Maintain in ice / water bath for 1 h 3. Maintain at -10–25 °C for 1 day Form E + Form A 2-BuOH 1. FC (55 °C to an ice / water bath) 2. Maintain at -10–25 °C for 11 days Form A 2-BuOH / t-BuOAc (2 / 1) 1. SAS, API solution in 2-BuOH in ice / water bath, add t-BuOAc to the API solution 2. Maintain at -10–25 °C for 7 days - CHCl₃ SE disordered DCE 1. FC (55 °C in an ice / water bath) 2. Maintained at -10–25 °C for 11 days 3. Stirred at room temperature for 3 days 4. FE (partial), stirred at room temperature for 5 days 5. FE (partial) Form A DCM SE Form D + additional phase(s) CC (room temperature at -78 °C) disordered suspension, 2–8 °C for 6 days Form H DMF / MTBE (3 / 97) 1. SAS, API solution in DMF in MTBE at room temperature 2. Maintained at -10–25 °C for 20 days disordered, Form A + additional phase(s) dioxane / DMSO 1. FC (55 °C in an ice / water bath) 2. Maintained at 2–8 °C for 11 days Form A 1. Solids in dioxane heated to 55 °C 2. DMSO added to 55 °C 3. FC in ice / water bath 4. maintained at 2-8 °C for 7 d Form A dioxane / H2O (1 / 1) 1. SAS, API solution in dioxane in cold H2O 2. stirred at 2-8 °C for 1 d Form A EtOAc / HFIPA 1. solids in EtOAc heated to 55 °C 2. HFIPA (36:64) added, stirred at 60 °C, 1 d 3. FC (60 °C to an ice / water bath) 4. FE, with N2 purge decomposed EtOH 1.FC (55 °C to an ice / water bath) 2. Maintained at -10— 25 °C for 11 days Form B + Minor Form A 1. CC (55 °C to -78 °C) 2. Inner wall of vial striped for nucleation, maintained at -10—25 °C for 3 days Form B with an additional peak at 5.9° 2Θ HFIPA SE Form F. HFIPA / EtOAc, anh. (1 / 25) 1. SAS, API solution in HFIPA in EtOAc 2. inner wall of vial striped for nucleation, keep at -10—25 °C for 3 days Form I MEK / BuOAc, anh. (1 / 1) 1. SAS, API solution in MEK in BuOAc 2. Maintained at -10—25 °C for 7 days 3. FE, TA Form E MEK / Methylcyclohexane (2 / 1) 1. SAS, API solution in MEK maintained in an ice / water bath, methylcyclohexane added to the API solution 2. Maintained at -10—25 °C for 3 days 3. FE under N2 purge for 2 h Form I with peak changes MeOH / nitromethane (1 / 1) 1. SAS, API solution in MeOH in an ice / water bath, nitromethane added to the API solution 2. FE (partial), RT 3. FE under N2 purge for 1 h Form E + Form A + additional phase(s) MeOH / BuOAc (2 / 1) 1. SAS, API solution in MeOH in BuOAc at TA 2. Maintains at -10— 25 °C for 7 days 3. FE, TA Form E + additional phase(s) NMP / PrOAc (5 / 95) 1. API solution in NMP added to PrOAc 2. Maintains at -10— 25 °C for 7 days ¡PrOAc / NMP 1.1. Solids in 1-PrOAc, heated to 55 °C 2. Added NMP at 55 °C 3. FC in ice / water bath 4. Maintained at -10— 25 °C for 7 days 1-PrOH / DMSO 1. Solids in 1-PrOH heated to 60 °C 2. Added DMSO 3. FC at TA 4. Maintained at -10— 25 °C for 20 days Form A. ΜΛ / Ε / ΖυΖο / υΊ ί ΙΛ I TFE FE Form G toluene / anhydrous DMSO 1. Solids in toluene heated to 45 °C 2. Anhydrous DMSO added at 45 °C 3. FC in ice / water bath 4. Add additional anhydrous toluene 5. Maintained at -10—25 °C for 7 days THF / H2O (93 / 7) 1. FE 2. Air dried on filter paper Form A *: Times and temperatures are approximate. Example 3: Preparation of Selected Materials ML / E / ZuZo / u 11 \l Table 15 summarizes the preparation conditions for the selected materials. Table 15 Solvent Conditions * XRPD Result anh. acetone 1. FC (55 °C to ice / water bath) 2. held at -10–25 °C for 5 days 3. FE (partial) under N2 purge, TA 4. held at -10–25 °C for 4 h 5. dried under vacuum at 45 °C for 1 day Form E DCM 1. suspended at TA for 9 d 2. air dried at TA for 1 h 3. dried under vacuum at 45 °C for 4 h Form D EtOH 1. FC (55 °C to ice / water bath) 2. held at -10–25 °C for 5 days 3. isolated solids, dried under vacuum at 45 °C for 4 h Form B, with additional peak at 5.9 0 2Θ *: Times and temperatures are approximate. Table 16 summarizes the drying conditions for the selected materials Table 16 Material Condition * XRPD Results Compound I Form F vacuum / 45 °C / 3 d Compound I Form D Compound I Form G empty / 45 °C / 3 d disordered Compound I Form E + Minor Form A empty / 45 °C / 1 d Compound I Form B + Minor Form A Compound I Material G empty / 45 °C / 1 d disordered Compound I Form C empty / 45 °C / 1 d Compound I Form D + additional peak empty / 45 °C / 1 h Compound I Form D Compound I Form I empty / 45 °C / 1 d Compound I Form B Compound I Form I with peak changes empty / 45 °C / 2 d similar to Compound I Form B *: Times and temperatures are approximate. Example 4: Competitive Suspension Experiment ML / E / ZuZo / u l (Ii In order to identify the most thermodynamically stable anhydrous form among Form A, Form D, Form B and Form E, competitive suspensions were made in acetone at 2-8sC, room temperature and 45sC. Under each condition, similar amounts of solids of the four forms / materials were suspended in presaturated solutions at the examined temperature conditions for 7 days; the solids were isolated and analyzed wet using XRPD. Detailed experimental conditions and XRPD results are summarized in Table 17. Materials Solvent * Condition ** XRPD Results 9 mg Form A 6 mg Form D 7 mg Form B 6 mg Form E acetone 2-8 °C, 7 d Form A 9 mg Form A 7 mg Form D 7 mg Form B 5 mg Form E acetone TA, 7 d Form A 9 mg Form A 8 mg Form D 6 mg Form B 7 mg Form E acetone 45 °C, 7 d Form A *: The solutions were pre-saturated with Form A under each condition. **: Times and temperatures are approximate. Powder X-ray Diffraction (XRPD) XRPD patterns were collected using a PANalytical XPERT PRO MPD or Empyrean diffractometer with an incident beam of Cu radiation produced by an Optix long fine-focus source. An elliptically graduated multilayer mirror was used to focus the Cu Ka X-ray radiation through the sample and onto the detector. Prior to analysis, a silicon sample (NIST SRM 640e) was analyzed to verify that the observed position of the Si(111) peak was consistent with the NIST-certified position. A sample of the sample was sandwiched between 3 pm thick films and analyzed in transmission geometry. A short antiscatter extension and an antiscatter knife edge were used to minimize air background. Soller slits were used for the incident and diffracted beams to minimize axial divergence broadening.Diffraction patterns were collected using a scan position sensitive detector (X'Celerator) located 240 mm from the sample and Data Collector v. 5.5 software. Thermogravimetric Analysis and Differential Scanning Calorimetry Combination Analysis (TGA / DSC) Combined TGA / DSC analyses were performed using a Mettler Toledo TGA / DSC3+ analyzer. Temperature and enthalpy settings were established using indium, tin, and zinc, and then verified with indium. Equilibrium was verified with calcium oxalate. The sample was placed in an aluminum tray. The tray was hermetically sealed, the lid was pierced, and it was then inserted into the TG furnace. A heavy aluminum tray, configured as the sample tray, was placed on the reference platform. The furnace was heated under nitrogen. Dynamic Vapor Sorption (DVS) Moisture sorption / desorption data were collected using an intrinsic instrument of the DVS Surface Measurement System. Samples were not dried prior to analysis. For the as-received batch, sorption and desorption data were collected over a 5% to 95% RH range in 10% RH increments. The equilibrium criterion used for analysis was less than 0.0100% weight change in 5 minutes, with a maximum equilibrium time of 3 hours. Data were not corrected for the initial moisture content of the samples. Hot phase microscopy (HSM) Hot-stage microscopy was performed using a Linkam hot stage (FTIR 600) mounted on a Leica DM LP microscope equipped with a SPOT Insight™ digital color camera. Temperature calibrations were performed using USP melting point standards. Samples were placed on a glass coverslip, and a second glass coverslip was placed on top of the sample. As the stage was heated, each sample was observed ML / E / ZuZo / uI í IL t visually using a 20x, 0.40 NA objective with crossed polarizers and a first-order red compensator. Images were captured using SPOT software (v. 4.5.9). Polarized light microscopy (PLM) PLM was performed using a Leica DM LP microscope equipped with a Spot Insight color camera. Cross-polarized light with a first-order red compensator was used. Several objectives were used to view the sample. Samples were suspended in mineral oil or the dispersant selected for the method. Images were acquired at room temperature using Spot Advanced software (v.4.5.9). Micrometer bars were inset into the images as a size reference. Particle sizes were measured using an eyepiece reticle scale calibrated with a NIST-traceable stage micrometer. Proton Solution Nuclear Magnetic Resonance Spectroscopy (1H NMR) The NMR solution spectra were acquired with a BRUKER AVANCE 600 MHz spectrometer using DMSO-oe. Carbon-13 Solid State Nuclear Magnetic Resonance Spectroscopy (13C solid state NMR) The solid-state 13C cross-polarization magic angle spin NMR (CP / mas) spectrum was acquired at room temperature on an Agilent DD2-400 spectrometer (Larmor frequencies: 13C = 100.549 MHz, 1H = 399.812 MHz). The sample was packed into a 4 mm PENCIL-type zirconia rotor and spun at 12 kHz at the magic angle. The spectrum was acquired with high-power phase-modulated 1H decoupling (SPINAL-64) during acquisition using a 1H pulse width of 2.6 ps (90°), an augmented-amplitude cross-polarization contact time of 5 ms, an acquisition time of 30 ms, a 10-second delay between scans, a spectral width of 45 kHz with 2678 data points and 1600 co-added scans. Free induction decay (FID) was processed using Agilent VnmrJ 3.2A software with 65536 points and an exponential line broadening factor of 10 Hz to improve the signal-to-noise ratio.The first three FID data points were re-predicted using the VNMR linear prediction algorithm to produce a flat baseline. The chemical shifts of the spectral peaks were externally referenced to the glycine carbonyl carbon resonance at 176.5 ppm. Infrared (IR) Spectroscopy. The IR spectrum was acquired using a Nicolet 6700 Fourier transform infrared (FT-IR) spectrophotometer (Thermo Nicolet) equipped with an Ever-Glo intermediate / far IR source, a potassium bromide (KBr) beam splitter, and a deuterated triglycine sulfate (DTGS) detector. Wavelength verification was performed using NIST SRM 1921b (polystyrene). An attenuated total reflectance (ATR) fixture (Thunderdome™, Thermo Spectra-Tech) equipped with a germanium (Ge) crystal was used for data acquisition. ML / E / ZuZo / u 11 \l The spectrum represents 256 co-added scans collected at a spectral resolution of 4 cm⁻¹. A background dataset was acquired using a clean Ge crystal. A Log 1 / Fγ spectrum (R = reflectance) was obtained by comparing these two datasets. XRPD Indexing The high-resolution XRPD pattern of Compound I was indexed using X'Pert High Score Plus 2.2a (2.2.1) in this study. Indexing and structure refinement are computational studies. The agreement between the allowed peak positions, marked with red bars, and the observed peaks indicates a consistent unit cell determination. Successful pattern indexing indicates that the sample consists mainly of a single crystalline phase. Consistent space clusters with the assigned extinction symbol, unit cell parameters, and derived quantities are tabulated below each figure showing the tentative indexing solution. To confirm the tentative indexing solution, molecular packing motifs within the crystallographic unit cells must be determined. No molecular packing attempts were made. Conclusion Multiple crystalline materials of Compound I were observed in this study, including the AJ Forms. Forms A, B, D, and E are anhydrous materials of Compound I. Among them, Form A is probably the most stable form within 2-8 °C at 45 °C based on competitive suspension results. Form C is probably a DCM solvate that desolvents into Form D. Form F is also a solvated material and becomes Form D upon drying. Form I could represent a family of isostructural solvates. It becomes Form E or Form E-like solids upon drying. Forms G and H are disordered crystalline materials and could be solvates. They become disordered upon drying. Although the invention has been described with respect to specific aspects thereof, it shall be understood that the invention is capable of further modifications and it is proposed that this application covers any variation, use or adaptation that generally follows the principles and includes such deviations from the present description that fall within the known or customary practice within the art to which the invention belongs and can be applied to the essential features set forth above, and remains within the scope of the claim.

Claims

1. A crystalline form of {2-[3-cyclohexyl-3-(trans-4-propoxycyclohexyl)-ureido]thiazol-5-11sulfanilyl}-acetic acid of Formula (I) ML / E / ZuZo / uI í II t (I), characterized in that it is selected from the group consisting of: a) a crystalline form characterized by an XRPD pattern having peaks at 16.9 ± 0.2, 17.4 ± 0.2 and 20.1 ± 0.2 degrees two theta; b) a crystalline form characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2 and 17.8 ± 0.2 degrees two theta; c) a crystal form characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 17.4 ± 0.2 and 21.6 ± 0.2 degrees two theta; d) a crystal form characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2 and 26.4 ± 0.2 degrees two theta; e) a crystal form characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2 and 18.9 ± 0.2 degrees two theta; f) a crystal form characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2 and 16.8 ± 0.2 degrees two theta; g) a crystal form characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2 and 21.9 ± 0.2 degrees two theta; h) a crystal form characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2 and 8.5 ± 0.2 degrees two theta; i) a crystal form characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 16.8 ± 0.2 and 18.8 ± 0.2 degrees two theta; yj) a crystalline form characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 17.4 ± 0.2 and 18.8 ± 0.2 degrees two theta.

2. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 16.9 ± 0.2, 17.4 ± 0.2 and 20.1 ± 0.2 degrees two theta.

3. The crystalline form according to claim 2, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 8.7 ± 0.2, 16.9 ± 0.2, 17.4 ± 0.2 and 20.1 ± 0.2 degrees two theta.

4. The crystalline form according to claim 2 or claim 3, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 1.

5. The crystalline form according to any of claims 2-4, characterized in that the crystalline form is characterized by an endothermic peak starting at approximately 160 °C, as determined by DSC.

6. The crystalline form according to any of claims 2-5, characterized in that the crystalline form is characterized by a DSC profile substantially as shown in FIGURE 2A.

7. The crystalline form according to any of claims 2-6, characterized in that the crystalline form is characterized by a TGA profile substantially as shown in FIGURE 2B.

8. The crystalline form according to any of claims 2-7, characterized in that the crystalline form is characterized by an IR pattern having peaks at 1099.7 ± 2.0, 1158.0 ± 2.0 and 1313.2 ± 2.0 cm1.

9. The crystalline form according to any of claims 2-8, characterized in that the crystalline form is characterized by an IR pattern having peaks at 1099.7 ± 2.0, 1158.0 ±2.0, 1238.7 ± 2.0 and 1313.2 ± 2.0 cm1.

10. The crystalline form according to any of claims 2-9, characterized in that the crystalline form is characterized by an IR pattern substantially as shown in FIGURE 3.

11. The crystalline form according to any of claims 2-10, characterized in that the crystalline form is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 4.

12. The crystalline form according to any of claims 2-11, characterized in that the crystalline form is anhydrous.

13. The crystalline form according to any of claims 2-12, characterized in that the crystalline form has a unit cell that is indexed as primitive monoclinic.

14. The crystalline form according to any of claims 2-13, characterized in that the crystalline form has a unit cell with a value of ML / E / ZuZo / uI í IL t approximately 10.193 Å, a value of b of approximately 12.256 Å and a value of c of approximately 18.991 Å.

15. The crystalline form according to any of claims 2-14, characterized in that the crystalline form has a unit cell with a volume of approximately 2370.9 Å3.

16. The crystalline form according to any of claims 2-15, characterized in that the crystalline form is Form A.

17. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2 and 17.8 ± 0.2 degrees two theta.

18. The crystalline form according to claim 17, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 11.0 ± 0.2, 11.6 ± 0.2, 17.8 ± 0.2 and 21.1 ± 0.2 degrees two theta.

19. The crystalline form according to claim 17 or claim 18, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 5.

20. The crystalline form according to any of claims 17-19, characterized in that the crystalline form is characterized by an endothermic peak starting at approximately 166 °C, as determined by DSC.

21. The crystalline form according to any of claims 17-20, characterized in that the crystalline form is characterized by a DSC profile substantially as shown in FIGURE 6A.

22. The crystalline form according to any of claims 17-21, characterized in that the crystalline form is characterized by a TGA profile substantially as shown in FIGURE 6B.

23. The crystalline form according to any of claims 17-22, characterized in that the crystalline form is characterized by an IR pattern having peaks at 1310.1 ±2.0, 1514.4 ± 2.0 and 1661.3 ± 2.0 cm-1.

24. The crystalline form according to any of claims 17-23, characterized in that the crystalline form is characterized by an IR pattern having peaks at 1097.3 ±2.0, 1310.1 ±2.0, 1541.4 ± 2.0 and 1661.3 ± 2.0 cm1.

25. The crystalline form according to any of claims 17-24, characterized in that the crystalline form is characterized by an IR pattern substantially as shown in FIGURE 7.

26. The crystalline form according to any of claims 17-25, characterized in that the crystalline form is characterized by a solid-state NMR at 13C MA / t / ZUZÓ / UΊ 11 \l substantially as shown in FIGURE 8.

27. The crystalline form according to any of claims 17-26, characterized in that the crystalline form is anhydrous.

28. The crystalline form according to any of claims 17-27, characterized in that the crystalline form has a unit cell that is indexed as primitive monoclinic.

29. The crystalline form according to any of claims 17-28, characterized in that the crystalline form has a unit cell with a value of approximately 11.028 Å, a b value of approximately 11.933 Å and a c value of approximately 18.737 Å.

30. The crystalline form according to any of claims 17-29, characterized in that the crystalline form has a unit cell with a volume of approximately 2449.0 Å3.

31. The crystalline form according to any of claims 17-30, characterized in that the crystalline form is Form B.

32. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 17.4 ± 0.2 and 21.6 ± 0.2 degrees two theta.

33. The crystalline form according to claim 32, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 4.3 ± 0.2, 8.0 ± 0.2, 17.4 ± 0.2 and approximately 21.6 ± 0.2 degrees two theta.

34. The crystalline form according to claim 32 or claim 33, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 9.

35. The crystalline form according to any of claims 32-34, characterized in that the crystalline form is characterized by an endothermic peak starting at approximately 149 °C, as determined by DSC.

36. The crystalline form according to any of claims 32-35, characterized in that the crystalline form is characterized by a DSC profile substantially as shown in FIGURE 10A.

37. The crystalline form according to any of claims 32-36, characterized in that the crystalline form is characterized by a TGA profile substantially as shown in FIGURE 10B.

38. The crystalline form according to any of claims 32-37, characterized in that the crystalline form is a dichloromethane solvate.

39. The crystalline form according to any of claims 32-38, MLE / E / ZυZO / υΊ ί ΙL t characterized in that the crystalline form has a unit cell that is indexed as primitive monoclinic.

40. The crystalline form according to any of claims 32-39, characterized in that the crystalline form has a unit cell with a value of approximately 5.541 Å, a b value of approximately 13.040 Å and a c value of approximately 40.818 Å.

41. The crystalline form according to any of claims 32-40, characterized in that the crystalline form has a unit cell with a volume of approximately 2947.6 Å3.

42. The crystalline form according to any of claims 32-41, characterized in that the crystalline form is Form C.

43. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2 and 26.4 ± 0.2 degrees two theta.

44. The crystalline form according to claim 43, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.3 ± 0.2, 8.7 ± 0.2, 18.2 ± 0.2 and 26.4 ± 0.2 degrees two theta.

45. The crystalline form according to claim 43 or claim 44, characterized by an XRPD pattern substantially as shown in FIGURE 11.

46. ​​The crystalline form according to any of claims 43-45, characterized in that the crystalline form is characterized by an endothermic peak starting at approximately 147 °C, as determined by DSC.

47. The crystalline form according to any of claims 43-46, characterized in that the crystalline form is characterized by a DSC profile substantially as shown in FIGURE 12A.

48. The crystalline form according to any of claims 43-47, characterized in that the crystalline form is characterized by a TGA profile substantially as shown in FIGURE 12B.

49. The crystalline form according to any of claims 43-48, characterized in that the crystalline form is characterized by a solid-state NMR at 13C substantially as shown in FIGURE 13.

50. The crystalline form according to any of claims 43-49, characterized in that the crystalline form is anhydrous.

51. The crystalline form according to any of claims 43-50, characterized in that the crystalline form is Form D.

52. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2 and 18.9 ± 0.2 degrees two theta.

53. The crystalline form according to claim 52, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.8 ± 0.2, 17.9 ± 0.2, 18.9 ± 0.2 and 20.7 ± 0.2 degrees two theta.

54. The crystalline form according to claim 52 or claim 53, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 14.

55. The crystalline form according to any of claims 52-54, characterized in that the crystalline form is characterized by an endothermic peak starting at approximately 171 °C, as determined by DSC.

56. The crystalline form according to any of claims 52-55, characterized in that the crystalline form is characterized by a DSC profile substantially as shown in FIGURE 15A.

57. The crystalline form according to any of claims 52-56, characterized in that the crystalline form is characterized by a TGA profile substantially as shown in FIGURE 15B.

58. The crystalline form according to any of claims 52-57, characterized in that the crystalline form is anhydrous.

59. The crystalline form according to any of claims 52-58, characterized in that the crystalline form is Form E.

60. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2 and 16.8 ± 0.2 degrees two theta.

61. The crystalline form according to claim 60, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 9.5 ± 0.2, 16.8 ± 0.2 and 17.9 ± 0.2 degrees two theta.

62. The crystalline form according to claim 60 or claim 61, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 16.

63. The crystalline form according to any of claims 60-62, characterized in that the crystalline form is a solvate.

64. The crystalline form according to any of claims 60-63, characterized in that the crystalline form is Form F.

65. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2 and MA / IZ / ZUZO / U1 l / 1 t 21.9 ± 0.2 degrees two theta.

66. The crystalline form according to claim 65, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 3.4 ± 0.2, 21.2 ± 0.2, 21.9 ± 0.2 and 22.4 ± 0.2 degrees two theta.

67. The crystalline form according to claim 65 or claim 66, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 17.

68. The crystalline form according to any of claims 65-67, characterized in that the crystalline form is a solvate.

69. The crystalline form according to any of claims 65-68, characterized in that the crystalline form is Form G.

70. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2 and 8.5 ± 0.2 degrees two theta.

71. The crystalline form according to claim 70, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 3.8 ± 0.2, 5.3 ± 0.2, 8.5 ± 0.2 and 15.9 ± 0.2 degrees two theta.

72. The crystalline form according to claim 70 or claim 71, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 18.

73. The crystalline form according to any of claims 70-72, characterized in that the crystalline form is a solvate.

74. The crystalline form according to any of claims 70-73, characterized in that the crystalline form is the H Form.

75. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 16.8 ± 0.2 and 18.8 ± 0.2 degrees two theta.

76. The crystalline form according to claim 75, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.0 ± 0.2, 15.9 ± 0.2, 16.8 ± 0.2 and 18.8 ± 0.2 degrees two theta.

77. The crystalline form according to claim 75 or claim 76, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 19.

78. The crystalline form according to any of claims 75-77, characterized in that the crystalline form is a solvate.

79. The crystalline form according to any of claims 75-78, MLE / E / ZυZO / υΊ í IL t characterized in that the crystalline form is Form I.

80. The crystalline form according to claim 1, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 17.4 ± 0.2 and 18.8 ± 0.2 degrees two theta.

81. The crystalline form according to claim 80, characterized in that the crystalline form is characterized by an XRPD pattern having peaks at 5.9 ± 0.2, 12.7 ± 0.2, 17.4 ± 0.2 and 18.8 ± 0.2 degrees two theta.

82. The crystalline form according to claim 80 or claim 81, characterized in that the crystalline form is characterized by an XRPD pattern substantially as shown in FIGURE 20.

83. The crystalline form according to any of claims 80-82, characterized in that the crystalline form is characterized by an endothermic peak starting at approximately 164 °C, as determined by DSC.

84. The crystalline form according to any of claims 80-83, characterized in that the crystalline form is characterized by a DSC profile substantially as shown in FIGURE 21 A.

85. The crystalline form according to any of claims 80-84, characterized in that the crystalline form is characterized by a TGA profile substantially as shown in FIGURE 21B.

86. The crystalline form according to any of claims 80-85, characterized in that the crystalline form is Form J.

87. The crystalline form according to any of claims 1-86, characterized in that the crystalline form is substantially free of other polymorphic forms.

88. The crystalline form according to any of claims 1-86, characterized in that the crystalline form has a polymorphic purity of at least approximately 80%.

89. The crystalline form according to any of claims 1-86, characterized in that the crystalline form has a polymorphic purity of at least approximately 90%.

90. The crystalline form according to any of claims 1-86, characterized in that the crystalline form has a polymorphic purity of at least approximately 95%.

91. The crystalline form according to any of claims 1-86, characterized in that the crystalline form has a polymorphic purity of at least approximately 99%.

92. A pharmaceutical composition characterized in that it comprises the crystalline form MLE / E / ZυZO / υΊ í IL t according to any of claims 1-91 and a pharmaceutically acceptable carrier, diluent or excipient, or a mixture thereof.

93. A method for treating a type of diabetes mellitus, characterized in that the method comprises administering the pharmaceutical composition according to claim 92 to a patient in need thereof.

94. The method according to claim 93, characterized in that the type of diabetes mellitus is type 1 diabetes mellitus.

95. The method according to claim 93, characterized in that the type of diabetes mellitus is type 2 diabetes mellitus.

96. The method according to any of claims 93-95, characterized in that the pharmaceutical composition is administered orally.

97. The method according to any of claims 93-96, characterized in that the pharmaceutical composition is administered as a tablet.

98. The method according to any of claims 93-97, characterized in that the patient is administered up to approximately 2000 mg of {2[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-11sulfanyl}-acetic acid once a day.

99. The method according to any of claims 93-97, characterized in that the patient is administered from approximately 100 mg to approximately 1500 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol5-ylsulfanyl}-acetic acid once a day.

100. The method according to any of claims 93-97, characterized in that the patient is administered approximately 500 mg to approximately 1000 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol5-ylsulfanyl}-acetic acid once a day.

101. The method according to any of claims 93-97, characterized in that the patient is administered approximately 800 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-11-sulfanil}-acetic acid once a day.

102. The method according to any of claims 93-97, characterized in that the patient is administered less than 800 mg of {2-[3-cyclohexyl-3(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-1-sulfanyl}-acetic acid once a day.

103. The method according to any of claims 93-97, characterized in that the patient is administered approximately 500 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-11-sulfanil}-acetic acid once a day.

104. The method according to any of claims 93-97, characterized in that the patient is administered approximately 300 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thazol-5-1-sulfanyl}-acetic acid once a day.

105. The method according to any of claims 93-97, characterized in that the patient is administered approximately 100 mg of {2-[3-cyclohexyl-3-(trans-4-propoxy-cyclohexyl)-ureido]-thiazol-5-ylsulfanyl}-acetic acid once a day.