---
title: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod
nct_id: NCT04819464
overall_status: COMPLETED
phase: PHASE1
sponsor: Viatris Innovation GmbH
study_type: INTERVENTIONAL
primary_condition: Healthy
countries: Hungary, Portugal
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04819464.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04819464"
ct_last_update_post_date: 2025-09-22
last_seen_at: "2026-05-12T06:35:56.613Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod

**Official Title:** 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

**NCT ID:** [NCT04819464](https://clinicaltrials.gov/study/NCT04819464)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 24
- **Lead Sponsor:** Viatris Innovation GmbH
- **Conditions:** Healthy, Hepatic Impairment
- **Start Date:** 2021-08-25
- **Completion Date:** 2024-08-18
- **CT.gov Last Update:** 2025-09-22

## Brief 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).

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 79 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
* Women of child bearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on Day -1, and must agree to consistently and correctly use a highly effective method of contraception (i.e., failure rate of less than 1%).
* Women of non-childbearing potential must have a medical history of previous bilateral salpingectomy, salpingo-oophorectomy or hysterectomy, premature ovarian failure confirmed by a specialist gynecologist; or, be post-menopausal, defined as 12 consecutive months with amenorrhea prior to screening without alternative medical cause and confirmed with a follicle-stimulating hormone test.
* Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening.
* Negative SARS-CoV-2-testing prior to Day -1 or documented vaccination against COVID-19 at least 3 months prior screening.
* Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the requirements of the study.

Exclusion Criteria:

General (Group A, B and C)

* Pregnant or lactating women.
* Participation in a clinical study involving study treatment administration within 30 days prior to screening or in more than 2 clinical studies within 1 year prior to screening.
* Previous exposure to cenerimod.
* History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, elimination (ADME) of the study treatment except for those related to liver cirrhosis or appendectomy and herniotomy.
* International Normalized Ratio greater than 2 at screening.
* Encephalopathy grade greater than or equal to 1.
* Clinically relevant abnormalities on a 12-lead ECG, recorded after 5 minutes in the supine position at screening and on Day 1 pre-dose.
* Presence of herpes simplex, disseminated zoster, or other opportunistic infections.
* Vaccination with live or live attenuated vaccines in the previous 4 weeks.
* Previous treatment with antiarrhythmic medications of class Ia or III 2 weeks or 5 half-lives, whichever is longer, prior to study treatment administration.
* Active retinopathy or macular edema at screening.
* Severe chronic obstructive pulmonary disease at screening.
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol.
* Legal incapacity or limited legal capacity at screening.

Additional exclusion criteria for participants with hepatic impairment (Group A and B)

* Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening and on Day -1, except for those related to liver cirrhosis.

Additional exclusion criteria for healthy subjects (Group C)

* Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening and on Day -1.
* Previous treatment with any prescribed medications (including vaccines) or over-the-counter (OTC) medications (including herbal medicines such as St. John\'s Wort, homeopathic preparations, vitamins, and minerals) within 2 weeks or 5 t½ prior to study treatment administration, whichever is longer (excluding contraceptives and HRT).
* Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
```

## Arms

- **Group A: Participants with mild hepatic impairment** (EXPERIMENTAL) — Participants with mild hepatic impairment (Child-Pugh Score of 5 to 6).
- **Group B: Participants with moderate hepatic impairment** (EXPERIMENTAL) — Participants with moderate hepatic impairment (Child-Pugh Score of 7 to 9).
- **Group C:Healthy participants** (EXPERIMENTAL) — Healthy participants will be matched to the participants with hepatic impairment based on age and body weight.

## Interventions

- **Cenerimod** (DRUG) — A single oral dose of 0.5 mg.

## Primary Outcomes

- **Area under the plasma concentration-time curves (AUC0-t): cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Area under the plasma concentration-time curve from zero to infinity (AUC0-inf): cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Maximum plasma concentration (Cmax): cenerimod.** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Time to reach Cmax (tmax): cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Terminal half-life (t½): cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Plasma protein binding of cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Apparent clearance (CL/F) of cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Apparent volume of distribution (Vz/F) of cenerimod** _(time frame: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_

## Secondary Outcomes

- **Total lymphocyte count** _(time frame: Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 98.)_
- **Change from baseline at each time point of measurement in electrocardiogram QT interval** _(time frame: Pre-defined times on Day 1 (pre-dose) up to Day 105.)_
- **Change from baseline in body weight** _(time frame: Day -1 and Day 105.)_
- **Change from baseline in systolic and diastolic blood pressure (in the supine position)** _(time frame: Predefined times on Day 1 (pre-dose) up to Day 105.)_
- **Incidence of abnormal laboratory test results** _(time frame: Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 105.)_
- **Adverse events and serious adverse events** _(time frame: Day 1 up to Day 105.)_

## Locations (2)

- CRU Hungary, Kistarcsa, Hungary
- BlueClinical Phase 1 Hospital de Prelado, Porto, Portugal

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.cru hungary|kistarcsa||hungary` — added _(2026-05-12)_
- `locations.blueclinical phase 1 hospital de prelado|porto||portugal` — added _(2026-05-12)_

---

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