Claims for Patent: 8,618,075

Summary for Patent: 8,618,075

Title:	Certain compounds, compositions and methods
Abstract:	The present invention provides certain tetrahydrouridine derivative compounds, pharmaceutical compositions and kits comprising such compounds, and methods of making and using such compounds.
Inventor(s):	Hamilton; Gregory S. (Catonsville, MD), Tsukamoto; Takashi (Ellicott City, MD), Ferraris; Dana V. (Eldersburg, MD), Duvall; Bridget (Nottingham, MD), Lapidus; Rena (Baltimore, MD)
Assignee:	Eisai Inc. (Woodcliff Lake, NJ)
Application Number:	13/556,404
Patent Claims:	1. A kit comprising a compound of Formula I, or a pharmaceutically acceptable salt thereof: ##STR00044## wherein the carbon marked by an asterisk may have an (R) or an (S) configuration; and wherein R.sub.1 and R.sub.2 are fluoro. 2. The kit of claim 1, wherein the compound is represented by Compound 1 a or a pharmaceutically acceptable salt thereof: ##STR00045## 3. The kit of claim 1, wherein the compound is represented by Compound 1 a: ##STR00046## 4. The kit of claim 1, further comprising a second compound which is a cytidine deaminase (CDA) substrate drug selected from the group consisting of 5-azacytidine, gemcitabine, ara-C, tezacitabine, 5-fluoro-2'-deoxycytidine, and cytochlor. 5. The kit of claim 1, further comprising a second compound which is a CDA substrate drug, wherein the CDA substrate drug is not decitabine. 6. The kit of claim 1, further comprising a second compound which is a CDA substrate drug, wherein the CDA substrate drug is decitabine. 7. The kit of claim 1, wherein the compound of Formula I or a pharmaceutically acceptable salt thereof is in a unit dosage form. 8. The kit of claim 1, further comprising information. 9. A kit comprising a pharmaceutical composition comprising a compound of Formula I, or a pharmaceutically acceptable salt thereof: ##STR00047## wherein the carbon marked by an asterisk may have an (R) or an (S) configuration; and wherein R.sub.1 and R.sub.2 are fluoro; and a pharmaceutically acceptable excipient. 10. The kit of claim 9, wherein the compound is represented by Compound 1 a or a pharmaceutically acceptable salt thereof: ##STR00048## 11. The kit of claim 9, wherein the compound is represented by Compound 1 a: ##STR00049## 12. The kit of claim 9, further comprising a second compound which is a CDA substrate drug selected from the group consisting of 5-azacytidine, gemcitabine, ara-C, tezacitabine, 5-fluoro-2'-deoxycytidine, and cytochlor. 13. The kit of claim 9, further comprising a second compound which is a CDA substrate drug, wherein the CDA substrate drug is not decitabine. 14. The kit of claim 9, further comprising a second compound which is a CDA substrate drug, wherein the CDA substrate drug is decitabine. 15. A method for inhibiting cytidine deaminase, comprising administering to a subject in need a composition comprising a compound of Formula I, or a pharmaceutically acceptable salt thereof: ##STR00050## wherein the carbon marked by an asterisk may have an (R) or an (S) configuration; and wherein R.sub.1 and R.sub.2 are fluoro; and a pharmaceutically acceptable excipient. 16. The method of claim 15, wherein the compound is represented by Compound 1 a or a pharmaceutically acceptable salt thereof: ##STR00051## 17. The method of claim 15, wherein the compound is represented by Compound 1 a: ##STR00052## 18. A method for inhibiting degradation of a CDA substrate drug by cytidine deaminase, comprising administering to a subject that is undergoing treatment with the CDA substrate drug a composition comprising a compound of Formula I, or a pharmaceutically acceptable salt thereof: ##STR00053## wherein the carbon marked by an asterisk may have an (R) or an (S) configuration; and wherein R.sub.1 and R.sub.2 are fluoro; and a pharmaceutically acceptable excipient. 19. The method of claim 18, wherein the compound is represented by Compound 1 a or a pharmaceutically acceptable salt thereof: ##STR00054## 20. The method of claim 18, wherein the compound is represented by Compound 1 a: ##STR00055##