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NCT03958864 · ClinicalTrials.gov registry record · Phase 1
A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 60
- Enrollment target
NCT03958864: Completed Phase 1 study, sponsored by Celgene.
NCT03958864 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 60 participants, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03958864, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 60 participants
- Enrollment target
Study 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).
Primary Outcome
Area under the plasma concentration-time curve from time zero to the time point of the last measurable concentration
Interventions
- DRUG CC-90001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2019-04-04 |
| Est. Completion | 2019-06-13 |
| Phase | Phase 1 |
What the finished NCT03958864 record still lists
NCT03958864 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which CC-90001 is the first listed.
NCT03958864 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03958864 about?
NCT03958864 is a clinical study titled "A Study of Safety, Tolerability, and Pharmacokinetics of Multiple-Dose CC-90001 in Japanese and Caucasian Healthy Subjects". 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. ...
What is the current status of trial NCT03958864?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 60 participants. The study started on 2019-04-04. Estimated completion is 2019-06-13.
What interventions are being tested in trial NCT03958864?
The interventions under investigation include: CC-90001 (DRUG).
Who is sponsoring clinical trial NCT03958864?
This trial is sponsored by Celgene, which has 308 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03958864's enrollment target sits among peer trials
60 831st of 2000 higher than 1,106 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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