NCT06528665

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

A Pharmacokinetic, Safety and Tolerability Formulation Screening Comparing Corplex Ozanimod TDS to Oral Ozanimod Capsules in Healthy Adults Subjects

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 24 (actual)
• Sponsor: Corium Innovations, Inc. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Detailed description

This is a single-dose, single-center, open-label, randomized, parallel relative bioavailability study (4 treatments and 1 period) of 3 test products of a Transdermal Delivery System of Ozanimod (Corplex Ozanimod TDS) with the Reference Listed Drug (Zeposia Capsule 0.92 mg), recruiting around 24 healthy (male: female = 1:1) subjects under fasting conditions. The following goals will be procured through this study: 1. To determine the pharmacokinetic profiles of Ozanimod and its' major metabolites (CC112273 and CC1084037) from the Corplex Ozanimod TDS (OZ-TDS 1, OZ-TDS 2 and OZ-TDS 3 manufactured by Corium Innovations, Inc.) (Test Product 1, Test Product 2 and Test Product 3) and the comparator (Zeposia Capsule 0.92 mg manufactured by Bristol Myers Squibb) (Reference Product) in healthy subjects; 2. To compare the relative bioavailability between the Corplex Ozanimod TDS and the oral capsules in healthy subjects; 3. To compare three formulations of the Corplex Ozanimod TDS in healthy subjects; 4. To determine the safety and tolerability of the Corplex Ozanimod TDS vs the oral capsules in healthy subjects.

Conditions

• Multiple Sclerosis
• Ulcerative Colitis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-02-10
• Primary completion: 2025-03-16
• Completion: 2025-04-16
• First posted: 2024-07-30
• Last updated: 2026-02-25

Locations

1 site across 1 country: Malaysia

Regulatory

• FDA-regulated drug study