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

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.

Timeline

Start

2020-10-07

Primary completion

2021-05-19

Completion

2021-06-01

Drugs

Indications

No indication recorded.