Study Complete
Sponsor ID
CC-10004-CP-033

Study to Evaluate the Pharmacokinetics of Single and Multiple Doses of Apremilast in Healthy Adult Male Korean Subjects

Sponsor ID
CC-10004-CP-033
Clinicaltrials.gov ID
NCT02802735
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

This two-part study was designed to evaluate the pharmacokinetics (PK) of single and multiple doses of apremilast in healthy adult Korean males.

Additional Study Details

Phase
Phase 1
Product
N/A
Type
Interventional
Masking
None (Open Label)
Enrollment
28
Additional Study Details

Protocol Summary

Primary Outcome Measures

Pharmacokinetics - Cmax

Timeframe: Up to 72 hours

Pharmacokinetics - AUCt

Timeframe: Up to 72 hours

Pharmacokinetics – AUC∞

Timeframe: Up to 72 hours

Pharmacokinetics – AUCτ

Timeframe: Up to 72 hours

Pharmacokinetics - Tmax

Timeframe: Up to 72 hours

Pharmacokinetics – t1/2

Timeframe: Up to 72 hours

Pharmacokinetics – CL/F

Timeframe: Up to 72 hours

Pharmacokinetics – Vz/F

Timeframe: Up to 72 hours

Secondary Outcome Measures

Adverse Events (AEs)

Timeframe: Up to 9 weeks

Locations

Location
Status
Contact Us
Location
Seoul National University Hospital
Seoul, Republic of Korea, 03080
Status
Completed