NCT05004311

The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Viatris Innovation GmbH · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.

Conditions

• Healthy
• Renal Impairment

Interventions

Type	Name	Description
DRUG	Cenerimod	A single oral dose of 0.5 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions

Timeline

• Start date: 2021-09-27
• Primary completion: 2023-07-27
• Completion: 2023-08-10
• First posted: 2021-08-13
• Last updated: 2025-09-22

Locations

1 site across 1 country: Portugal