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

NCT07301723 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2026-03-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Viatris Innovation GmbH

    lead INDUSTRY

Principal Investigators

  • Clinical Trials · Viatris Innovation GmbH

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-12-11
Primary Completion
2026-03-18
Completion
2026-03-18

Countries

  • Netherlands

Study Locations

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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 NCT07301723 on ClinicalTrials.gov