drugset / Trial / NCT03958864
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
RandomizedParallel-groupOpen-labelOther
Summary
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).
Timeline
- Start
- 2019-04-04
- Primary completion
- 2019-06-13
- Completion
- 2019-06-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CC-90001 | Small molecule | 100 mg | Oral |
| Subject | CC-90001 | Small molecule | 200 mg | Oral |
| Subject | CC-90001 | Small molecule | 400 mg | Oral |
Indications
No indication recorded.