Study Complete
Sponsor ID
CC-10004-CP-035

A Study to Evaluate the Pharmacokinetic Exposure of 2 Formulations of Apremilast in Healthy Adults

Sponsor ID
CC-10004-CP-035
Clinicaltrials.gov ID
NCT02777554
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

The purpose of this study is to evaluate the relative bioavailability of apremilast once-daily formulation relative to a twice daily formulation when administered as multiple doses (Part 1), and when administered as a single dose under fasting and fed conditions (Part 2). Information on safety and tolerability will also be obtained.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
144
Additional Study Details

Protocol Summary

Primary Outcome Measures

Part 1: Peak Maximum Plasma Concentration (Cmax) of Apremilast

Timeframe: Apremilast IR: Day 7 predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, and 24 hours after the morning dose. Apremilast XL: Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours after the morning dose.

Part 1: Area Under the Concentration-time Curve from Time Zero to 24 hours Postdose (AUC0-24) of Apremilast

Timeframe: Apremilast IR: Day 7 predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, and 24 hours after the morning dose. Apremilast XL: Day 7 predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, and 24 hours after the morning dose.

Part 2: Peak Maximum Plasma Concentration (Cmax) of Apremilast

Timeframe: Apremilast IR: Predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the morning dose. Apremilast XL: Predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, 60, and 72 hours postdose.

Part 2: Area Under the Plasma Concentration-time Curve from Time Zero to the Last Observable Concentration (AUC0-t) of Apremilast

Timeframe: Apremilast IR: Predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the morning dose. Apremilast XL: Predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, 60, and 72 hours postdose.

Part 2: Area Under the Plasma Concentration-time Curve from Time Zero Extrapolated to Infinity (AUC0-∞) of Apremilast

Timeframe: Apremilast IR: Predose and at 0.5, 1, 2, 3, 5, 8, 12, 12.5, 13, 14, 15, 17, 20, 24, 36, 48, 60, and 72 hours after the morning dose. Apremilast XL: Predose and at 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 14, 16, 20, 24, 30, 36, 48, 60, and 72 hours postdose.

Secondary Outcome Measures

Number of Participants with Treatment-emergent Adverse Events

Timeframe: Part 1: Up to 7 days after last dose in each treatment period (14 days); Part 2: Up to 7 days after each dose.

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit Inc
Madison, Wisconsin, United States, 53704
Status
Completed
Location
Covance-Daytona Beach
Daytona Beach, Florida, United States, 32117
Status
Completed