Study to Evaluate Bioavailability of Apremilast Oral Suspension Relative to Tablet and to Assess Effect of Food on the Pharmacokinetics (PK) of the Oral Suspension
Study Details
The purpose of this study is to assess how much of apremilast is found in the blood unchanged when administered as an oral suspension compared to when it is administered as a tablet formulation. The effect of food on apremilast oral suspension will also be evaluated. In addition, information on the safety and tolerability of apremilast will be obtained.
Protocol Summary
Maximum Observed Plasma Concentration (Cmax) of Apremilast
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Area Under the Concentration-time Curve from Time Zero to the Last Measured Time Point (AUC0-t) for Apremilast
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Area Under the Concentration-time Curve from Time Zero to Infinity (AUC0-∞) for Apremilast
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Time to Maximum Observed Plasma Concentration (Tmax) of Apremilast
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Terminal Elimination Half-life (T1/2) of Apremilast
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Apparent Clearance of Apremilast from Plasma after Extravascular Administration (CL/F)
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Apparent Volume of Distribution of Apremilast During the Terminal Phase (Vz/F)
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Lag Time (Tlag) of Apremilast
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Relative Bioavailability (F) of Apremilast Oral Suspension Formulation
Timeframe: Predose and at 0.5, 1, 1.5, 2, 3, 5, 8, 12, 24, 36, 48, 60 and 72 hours after dosing on day 1 of each treatment period.
Number of Participants with Treatment-emergent Adverse Events
Timeframe: From first dose of study drug in treatment period 1 to 8 days after the last dose; up to 26 days.