Method for increasing the bioavailability of the active form of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino) phenyl] 2-methylpropanethioate

1. A method of increasing the bioavailability of the active form of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate to a patient receiving S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate therapy comprising orally administering to the patient once per day a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food, wherein the food is not part of the pharmaceutical composition.

2. The method of claim 1 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

3. The method of claim 2 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

4. The method of claim 1 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

5. The method of claim 4 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

6. The method of claim 4 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

7. The method of claim 1 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

8. The method of claim 7 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate.

9. The method of claim 8 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.

10. The method of claim 1 , wherein the administration results in an increase in the maximum plasma concentration of the active form of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate as compared to the administration of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate without food.

11. The method of claim 1 , wherein the pharmaceutical composition is provided to a patient in a container associated with prescribing information that advises the patient that the pharmaceutical composition is to be administered with food.

12. The method of claim 11 , wherein prescribing information further advises the patient that the administration of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food results in an increase of the maximum plasma concentration of the active form of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate as compared to the administration of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate under fasted conditions.

13. The method of claim 11 , wherein the prescribing information further advises the patient to administer the pharmaceutical composition between about 1 hour prior to consuming food to about 2 hours after consuming food.

14. The method of claim 13 , wherein the prescribing information further advises the patient to administer the pharmaceutical composition substantially at the same time as consuming food.

15. The method of claim 13 , wherein the prescribing information further advises the patient to administer the pharmaceutical composition immediately after consuming food to up to about 1 hour after consuming food.

16. A method of increasing the extent of absorption of the active form of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate as measured by the active form concentration attained in the blood stream over time in a patient in need of a therapeutic effect thereof comprising orally administering to the patient a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food, wherein the food is not part of the pharmaceutical composition.

17. The method of claim 16 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

18. The method of claim 17 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

19. The method of claim 16 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

20. The method of claim 19 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

21. The method of claim 19 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

22. The method of claim 16 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

23. The method of claim 22 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate.

24. The method of claim 23 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.

25. A method for decreasing the activity of cholesteryl ester transfer protein (CETP) in a patient, which comprises orally administering to the patient once per day a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food wherein the food is not part of the pharmaceutical composition.

26. The method of claim 25 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

27. The method of claim 26 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

28. The method of claim 25 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

29. The method of claim 28 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

30. The method of claim 28 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

31. The method of claim 25 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

32. The method of claim 31 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate.

33. The method of claim 32 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.

34. A method for the treatment or prophylaxis of a cardiovascular disorder in a patient, which comprises orally administering to the patient once per day a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food, wherein the food is not part of the pharmaceutical composition.

35. The method of claim 34 , wherein the cardiovascular disorder is selected from the group consisting of cardiovascular disease, coronary heart disease, coronary artery disease, hypoalphalipoproteinemia, hypercholesterolemia, and atherosclerosis.

36. The method of claim 34 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

37. The method of claim 36 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

38. The method of claim 34 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

39. The method of claim 38 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

40. The method of claim 38 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

41. The method of claim 34 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

42. The method of claim 41 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate.

43. The method of claim 42 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.

44. A method for increasing plasma high-density lipoprotein (HDL) cholesterol in a patient, which method comprises orally administering to the patient once per day a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food, wherein the food is not part of the pharmaceutical composition.

45. The method of claim 44 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

46. The method of claim 45 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

47. The method of claim 44 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

48. The method of claim 47 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

49. The method of claim 47 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

50. The method of claim 44 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

51. The method of claim 50 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate.

52. The method of claim 51 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.

53. A method for decreasing plasma low-density lipoprotein (LDL) cholesterol in a patient, which method comprises orally administering to the patient once per day a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food, wherein the food is not part of the pharmaceutical composition.

54. The method of claim 53 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

55. The method of claim 54 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

56. The method of claim 53 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

57. The method of claim 56 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

58. The method of claim 56 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

59. The method of claim 53 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

60. The method of claim 59 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate.

61. The method of claim 60 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.

62. A method for decreasing plasma LDL cholesterol and increasing HDL cholesterol in a patient, which method comprises orally administering to the patient once per day a therapeutically effective amount of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate in a pharmaceutical composition with food, wherein the food is not part of the pharmaceutical composition.

63. The method of claim 62 , wherein the therapeutically effective amount is about 100 mg to about 1800 mg.

64. The method of claim 63 , wherein the therapeutically effective amount is about 300 mg to about 900 mg.

65. The method of claim 62 , wherein the administration to the patient occurs between about 1 hour prior to consuming food to about 2 hours after consuming food.

66. The method of claim 65 , wherein the administration to the patient is substantially at the same time as the consumption of the food.

67. The method of claim 65 , wherein the administration to the patient is immediately after the consumption of food to up to about 1 hour after the consumption of food.

68. The method of claim 62 , wherein the pharmaceutical composition is in a unit dosage form of a tablet.

69. The method of claim 68 , wherein the tablet comprises about 100 mg to about 1800 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate .

70. The method of claim 69 , wherein the tablet comprises about 300 mg of S-[2-([[1-(2-ethylbutyl)cyclohexyl]carbonyl]amino)phenyl]2-methylpropanethioate, and the therapeutically effective amount is about 300 mg to about 900 mg.