drugset / Trial / NCT04149678
Drug Interaction Study of the Effect on Cyclosporine on Ozanimod and Major Active Metabolites
RandomizedParallel-groupOpen-labelTreatment
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
Timeline
- Start
- 2019-10-04
- Primary completion
- 2019-11-13
- Completion
- 2019-12-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclosporine | Peptide | 600 mg | Oral |
| Subject | Ozanimod | Small molecule | 0.46 mg | Oral |
Indications
No indication recorded.