NCT04149678

Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites

A Phase 1, Randomized, Parallel-group, Open-label Study to Evaluate the Effect of Cyclosporine on the Single-dose Pharmacokinetics of Ozanimod and Major Active Metabolites in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Celgene · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	Ozanimod	Ozanimod
DRUG	Cyclosporine	Cyclosporine

Timeline

• Start date: 2019-10-04
• Primary completion: 2019-11-13
• Completion: 2019-12-26
• First posted: 2019-11-04
• Last updated: 2020-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study