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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 56 participants.
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
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03363815
The ClinicalTrials.gov registry entry for NCT03363815 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 56 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 5 interventions - of which Midazolam is the first listed.
NCT03363815 reports 0 study locations.
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.
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