Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men
Study Details
This study will assess up to 12 different oral formulations of apremilast to determine how much apremilast is absorbed by the body compared to a reference formulation.
Protocol Summary
Pharmacokinetics (PK): Cmax
Timeframe: Approximately 8 weeks for Groups 1 &2/scenario 1; approximately 6 weeks for Group 2/scenario 2, approximately 5-6 weeks for Group 3
PK: AUC0-t
Timeframe: Approximately 8 weeks for Groups 1 &2/scenario 1; approximately 6 weeks for Group 2/scenario 2, approximately 5-6 weeks for Group 3
PK: Area Under the Curve - Infinity AUC0–∞
Timeframe: Approximately 8 weeks for Groups 1 &2/scenario 1; approximately 6 weeks for Group 2/scenario 2, approximately 5-6 weeks for Group 3
PK: Terminal Half Life
Timeframe: Approximately 8 weeks for Groups 1 &2/scenario 1; approximately 6 weeks for Group 2/scenario 2, approximately 5-6 weeks for Group 3
PK: T max
Timeframe: Approximately 8 weeks for Groups 1 &2/scenario 1; approximately 6 weeks for Group 2/scenario 2, approximately 5-6 weeks for Group 3
PK: CL/F
Timeframe: Approximately 8 weeks for Groups 1 &2/scenario 1; approximately 6 weeks for Group 2/scenario 2, approximately 5-6 weeks for Group 3
Number and incidence of Adverse Events (AE)
Timeframe: From the time the subject signs the ICF through 28 days after the last dose of study drug; Up to 8 weeks