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A Study to Evaluate the Relative Bioavailability of a Pediatric Granule Formulation of Ozanimod in Healthy Adult Subjects

NCT04528290 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2021-09-20

No results posted yet for this 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.

Conditions

  • Healthy Volunteers

Interventions

DRUG

Ozanimod

Ozanimod capsule formulation of 0.92mg

DRUG

Ozanimod

Ozanimod, granule formulation of 0.92mg

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-10-07
Primary Completion
2021-05-19
Completion
2021-06-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04528290 on ClinicalTrials.gov