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NCT04149678 · ClinicalTrials.gov registry record · Phase 1
Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
NCT04149678: Completed Phase 1 study, sponsored by Celgene.
NCT04149678 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04149678, a Phase 1 study, has completed, sponsored by Celgene.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
Study Summary
This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows: * Treatment Group A (reference): A single oral dose of ozanimod 0.46 mg * Treatment Group B (test): A single oral dose of ozanimod 0.46 mg plus a single oral dose of cyclosporine 600 mg
Primary Outcome
Maximum observed plasma concentration
Interventions
- DRUG Cyclosporine
- DRUG Ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2019-10-04 |
| Est. Completion | 2019-12-26 |
| Phase | Phase 1 |
What the finished NCT04149678 record still lists
NCT04149678 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).
The record links to 0 conditions, and to 2 interventions - of which Cyclosporine is the first listed.
NCT04149678 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04149678 about?
NCT04149678 is a clinical study titled "Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites". This is a Phase 1, randomized, parallel-group, open-label study. Forty subjects will be enrolled and will be randomized into 1 of the 2 treatment groups, with 20 subjects in each treatment group(sex will be used as a stratifying factor) as follows: * Treatment Group A (reference): A single oral dos...
What is the current status of trial NCT04149678?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2019-10-04. Estimated completion is 2019-12-26.
What interventions are being tested in trial NCT04149678?
The interventions under investigation include: Cyclosporine (DRUG), Ozanimod (DRUG).
Who is sponsoring clinical trial NCT04149678?
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 NCT04149678's enrollment target sits among peer trials
40 1130th of 2000 higher than 810 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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