NCT07301723

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: Male
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy Subjects

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-12-11
• Primary completion: 2026-03-18
• Completion: 2026-03-18
• First posted: 2025-12-24
• Last updated: 2026-03-30

Locations

1 site across 1 country: Netherlands