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A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants
Sponsor: Viatris Innovation GmbH
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
Conditions
Interventions
Cenerimod (oral)
A single dose of cenerimod, administered as an oral tablet at a strength of 4 mg
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