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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 40 participants.
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
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04149678
The ClinicalTrials.gov registry entry for NCT04149678 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 40 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 2 interventions - of which Cyclosporine is the first listed.
NCT04149678 reports 0 study locations.
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.
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