NCT03958864

A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects

A PHASE 1, OPEN LABEL STUDY TO EVALUATE THE PHARMACOKINETICS AND SAFETY/TOLERABILITY OF CC-90001 IN JAPANESE HEALTHY SUBJECTS

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Volunteer

Interventions

Type	Name	Description
DRUG	CC-90001	CC-90001

Timeline

• Start date: 2019-04-04
• Primary completion: 2019-06-13
• Completion: 2019-06-13
• First posted: 2019-05-22
• Last updated: 2020-05-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study