Last reviewed · How we verify
NCT04819464
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod
Phase 1 trial testing Cenerimod in Healthy in 24 participants. Completed in 18 August 2024.
18 August 2024
Quick facts
| Lead sponsor | Viatris Innovation GmbH |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | sequential |
| Masking | none |
| Primary purpose | other |
| Enrollment | 24 |
| Start date | 25 August 2021 |
| Primary completion | 18 August 2024 |
| Estimated completion | 18 August 2024 |
| Sites | 2 locations across Portugal, Hungary |
Drugs / interventions tested
- Cenerimod — full drug profile →
Conditions studied
- Healthy — all drugs for Healthy →
- Hepatic Impairment — all drugs for Hepatic Impairment →
Sponsor
Viatris Innovation GmbH — full company profile →
Who can join
Adults 18 to 79, any sex, with Healthy or Hepatic Impairment. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04819464
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cenerimod
Trials testing the same drug.
- NCT05672576 — A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosu · Phase 3 · active not recruiting
- NCT05648500 — A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythemat · Phase 3 · recruiting
- NCT05004311 — The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics · Phase 1 · completed
- NCT04052360 — Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects · Phase 1 · completed
- NCT02914223 — A Study to Evaluate Cenerimod in Healthy Male Subjects · Phase 1 · completed
Other recruiting trials for Healthy
Currently open trials in the same condition.
- NCT06707207 — Predicting Future Errors During Skill Performance · recruiting
- NCT07169630 — PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI) · Phase 1 · recruiting
- NCT07499414 — The Effects of the Bile Acid Supplement, 7-keto Lithocholic Acid, on Human Gut Microbiota and Risk Factors for Disease. · NA · recruiting
- NCT07496697 — Effects of Electroacupuncture at NP82 and SP15 on Bowel Motility in Healthy Subjects · NA · recruiting
- NCT06431932 — Pilot Trial of Fisetin in Healthy Volunteers and Older Patients With Multimorbidity · Phase 1, PHASE2 · recruiting
Other Viatris Innovation GmbH trials
Trials by the same sponsor.
- NCT07301723 — A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants · Phase 1 · completed
- NCT07133191 — A Trial to Compare What the Body Does to Selatogrel and the Effect of Selatogrel in Japanese and Caucasian Healthy Parti · Phase 1 · completed
- NCT05672576 — A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosu · Phase 3 · active not recruiting
- NCT05648500 — A Research Study to Evaluate the Effects of a New Oral Medicine Called Cenerimod in Adults With Systemic Lupus Erythemat · Phase 3 · recruiting
- NCT05004311 — The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04819464 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Viatris Innovation GmbH
- Last refreshed: 22 September 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04819464.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing