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

NCT04149678 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2020-08-24

No results posted yet for this study

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

DRUG

Ozanimod

Ozanimod

DRUG

Cyclosporine

Cyclosporine

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Jonathan Tran, Pharm.D · Celgene

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-10-04
Primary Completion
2019-11-13
Completion
2019-12-26
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 NCT04149678 on ClinicalTrials.gov