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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 is a Phase 1 study that has completed, run by Celgene. The registered enrollment target is 56 participants.
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.
Interventions
- DRUG Ozanimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2020-10-07 |
| Est. Completion | 2021-06-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04528290
The ClinicalTrials.gov registry entry for NCT04528290 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 1 intervention - of which Ozanimod is the first listed.
NCT04528290 reports 0 study locations.
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.
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