Healthy Volunteer Clinical Trial
Official title:
A Phase 1, Open-Label, Randomized, Two-Period, Two-Sequence Crossover Study to Assess the Effect of Food on the Pharmacokinetics of a Single 30 mg Tablet of Apremilast (CC-10004) in Healthy Subjects
The purpose of the study is to evaluate the effects of a high fat meal on the pharmacokinetics of a single dose of 30 mg apremilast in healthy adults.
Participants will be randomized to receive a single dose of 30 mg apremilast during each of the 2 periods; once under fasting conditions and once after a high fat meal. Participants will be randomly assigned to receive apremilast either fasted first, then fed, or fed first then fasted. Participants will check into the study center on Day -1 of each period, will be dosed on Day 1, and discharged from the study center on Day 3 after all scheduled pharmacokinetic blood draws and safety evaluations. After a washout of 5 to 10 days, participants will return for period 2 during which they will receive apremilast according to their assigned sequence. ;
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