Study Complete
Sponsor ID
CC-10004-CP-032

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

Sponsor ID
CC-10004-CP-032
Clinicaltrials.gov ID
NCT02641353
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
34
Additional Study Details

Protocol Summary

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704
Status
Completed