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NCT03363815 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT03363815: Completed Phase 1 study, sponsored by Celgene.
NCT03363815 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 56 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
NCT03363815, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 56 participants
- Enrollment target
Study Summary
This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label, two-period study. The study parts can be run in any order and can be, but do not have to be, run in parallel. Subjects may participate in one part only. For each part, each subject will participate as follows: * Screening (Days -21 through -2) * Baseline phase for each study period (Periods 1 and 2) * Treatment phase for each study period (Periods 1 and 2) * Follow-up telephone call
Primary Outcome
Maximum observed plasma concentration
Interventions
- DRUG Midazolam
- DRUG Omeprazole
- DRUG Warfarin
- DIETARY_SUPPLEMENT Vitamin K
- DRUG CC-90001
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2017-12-04 |
| Est. Completion | 2018-07-29 |
| Phase | Phase 1 |
What the finished NCT03363815 record still lists
NCT03363815 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 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 5 interventions - of which Midazolam is the first listed.
NCT03363815 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03363815 about?
NCT03363815 is a clinical study titled "A Study to Evaluate the Effect of Multiple Doses of CC-90001 on the Pharmacokinetics of Omeprazole, Midazolam, Warfarin, Rosuvastatin, Metformin, Digoxin, and Nintedanib in Healthy Adult Subjects". This is a four-part study to evaluate the effect of multiple doses of CC-90001 on the PK, safety, and tolerability of single doses of omeprazole, midazolam, warfarin, rosuvastatin, metformin, digoxin, and nintedanib in healthy subjects. Each study part is a nonrandomized, fixed-sequence, open-label,...
What is the current status of trial NCT03363815?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2017-12-04. Estimated completion is 2018-07-29.
What interventions are being tested in trial NCT03363815?
The interventions under investigation include: Midazolam (DRUG), Omeprazole (DRUG), Warfarin (DRUG), Vitamin K (DIETARY_SUPPLEMENT), CC-90001 (DRUG).
Who is sponsoring clinical trial NCT03363815?
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 NCT03363815's enrollment target sits among peer trials
56 902nd of 2000 higher than 1,083 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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