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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 60 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03958864
The ClinicalTrials.gov registry entry for NCT03958864 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 60 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Celgene, which has 308 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CC-90001 is the first listed.
NCT03958864 reports 0 study locations.
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.
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