Study Complete
Sponsor ID
CC-10004-CP-027

Study to Evaluate Pharmacokinetics of Prototype Modified-Release Formulations Of Apremilast in Healthy Men

Sponsor ID
CC-10004-CP-027
Clinicaltrials.gov ID
NCT02236988
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
80
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Covance Clinical Research Unit Inc.
Madison, WI, United States, 53704-2526
Status
Recruiting