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Determine PK Profiles of Ozanimod and Its' Major Metabolites in Healthy Subjects

NCT06528665 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2026-02-25

No results posted yet for this study

Summary

The goal of this clinical trial is to learn how Ozanimod drug can be administered to the healthy subjects via transdermal delivery system (TDS, patch) to achieve better drug absorption and delivery than via oral capsules (Zeposia). Researchers will compare two administered routes of Ozanimod TDS and oral Zeposia in drug pharmacokinetics, tolerability and safety. Participants will either take one capsule only or wear a patch on his/her arm for 7 days, and blood samples will be collected to measure drug concentrations and local skin reactions will be also observed.

Conditions

Interventions

DRUG

ZEPOSIA® indicated for the treatment of: Relapsing forms of multiple sclerosis, and active ulcerative colitis in adults

ZEPOSIA® * Titration is required for treatment initiation. * The recommended maintenance dosage is 0.92 mg orally once daily. * If a dose is missed within the first 2 weeks of treatment, reinitiate with the titration regimen. If a dose is missed after the first 2 weeks of treatment, continue treatment as planned.

Sponsors & Collaborators

  • Corium Innovations, Inc.

    lead INDUSTRY

Principal Investigators

  • Damenthi Nair, MD · Hospital Ampang, 68000 Ampang, Malaysia

Eligibility

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

Timeline & Regulatory

Start
2025-02-10
Primary Completion
2025-03-16
Completion
2025-04-16
FDA Drug
Yes

Countries

  • Malaysia

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Entities

Diseases

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 NCT06528665 on ClinicalTrials.gov