NCT04819464

A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod

An Open-label, Parallel-group Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Cenerimod After Single-dose Administration in Subjects With Hepatic Impairment and in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This is a prospective, open-label, single-dose, phase 1 study, to assess the effect of mild and moderate hepatic impairment on the pharmacokinetics of cenerimod (ACT-334441).

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	Cenerimod	A single oral dose of 0.5 mg.

Timeline

• Start date: 2021-08-25
• Primary completion: 2024-08-18
• Completion: 2024-08-18
• First posted: 2021-03-29
• Last updated: 2025-09-22

Locations

2 sites across 2 countries: Hungary, Portugal