This is a Phase 1, open-label, randomized, parallel design study to evaluate the PK and safety/tolerability of CC 90001 in Japanese and Caucasian healthy adult subjects. The study will consist of multiple oral doses of IP (QD x 7 days) in 3 planned dose level cohorts of 100 mg, 200 mg, and 400 mg. Each cohort will have 20 subjects (10 Japanese subjects and 10 Caucasian subjects, with a minimum of 8 subjects to complete in each group) who will receive IP (see below).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
60
CC-90001
Paraxel International
Glendale, California, United States
Pharmacokinetic- AUC0-t
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- AUC0-∞
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- CL/F
Estimation of apparent clearance of drug from plasma after extravascular administration
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- Vz/F
Estimation of apparent volume of distribution during the terminal phase
Time frame: Day 1 and Day 7- 10
Pharmacokinetic- Cmax
Estimation of observed maximum plasma concentration
Time frame: Day 1 and Day 7
Pharmacokinetic- Tmax
Estimation of time to Cmax
Time frame: Day 1 and Day 7
Pharmacokinetic- t1/2
Description: Estimation of terminal elimination half-life
Time frame: Day 1 and Day 7- 10
Adverse Events (AEs)
Number participants with Adverse Event
Time frame: From enrollment until at least 28 days after completion of study treatment
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