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NCT04528290 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects
A Phase 1 study, sponsored by Celgene.
- Completed
- Registry status
- Phase 1
- Development phase
- 56
- Enrollment target
NCT04528290: Completed Phase 1 study, sponsored by Celgene.
NCT04528290 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
NCT04528290, 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 Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as follows: * Treatment Group A (reference): Current ozanimod capsule formulation * Treatment Group B (test): Ozanimod granule formulation participants will be screened within 28 days prior to dosing. Eligible participants will be admitted to the clinical research unit one day before dosing (Day -1) and will be domiciled until Day 15. On Day 1, a single oral dose of 0.92 mg of ozanimod will be administered using either the current capsule formulation (Group A) or the granule formulation (Group B). Participants will be contacted by telephone 30 ± 5 days after dosing for a follow up safety assessment.
Primary Outcome
Maximum observed plasma concentration
Interventions
- DRUG Ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 1 |
What the finished NCT04528290 record still lists
NCT04528290 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 1 intervention - of which Ozanimod is the first listed.
NCT04528290 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04528290 about?
NCT04528290 is a clinical study titled "A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects". This is a Phase 1, open-label, randomized, parallel-group, single-dose study. Approximately 56 participants will be enrolled and randomized into 1 of the 2 treatment groups, with 28 participants in each treatment group as follows: * Treatment Group A (reference): Current ozanimod capsule formulatio...
What is the current status of trial NCT04528290?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 56 participants. The study started on 2020-10-07. Estimated completion is 2021-06-01.
What interventions are being tested in trial NCT04528290?
The interventions under investigation include: Ozanimod (DRUG).
Who is sponsoring clinical trial NCT04528290?
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 NCT04528290'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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