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COMPLETED
NCT07301723
PHASE1

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants

Sponsor: Viatris Innovation GmbH

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn about the absolute bioavailability of cenerimod in healthy participants. It will also provide information about the safety of cenerimod. Participants will receive one tablet with cenerimod, followed by an intravenous (i.v.) infusion with a 14C-radiolabeled cenerimod microtracer (cenerimod with a very low dose of radioactivity) 6 hours later. Participants will stay at the clinic for a total of 4 days, and will return to the clinic for further tests over the course of approximately 3 months.

Official title: A Single-center, Open-label Trial to Determine the Absolute Bioavailability of Cenerimod Using an Intravenous 14C-radiolabeled Cenerimod Microtracer in Healthy Male Participants

Key Details

Gender

MALE

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2025-12-11

Completion Date

2026-03-18

Last Updated

2026-07-14

Healthy Volunteers

Yes

Interventions

DRUG

Cenerimod (oral)

A single dose of cenerimod, administered as an oral tablet at a strength of 4 mg

DRUG

14C-Cenerimod (i.v.)

A single i.v. dose of 7.5 µg 14C-radiolabeled cenerimod (34.5 kBq), with administration starting 6 h after administration of the oral dose.

Locations (1)

Pharmaceutical Research Associates Group B.V.

Groningen, Netherlands