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

NCT ID: NCT04819464

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-25
• Study Completion Date: 2024-08-18

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).

Conditions

Healthy; Hepatic Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Group A: Participants with mild hepatic impairment

Participants with mild hepatic impairment (Child-Pugh Score of 5 to 6).

Group Type: EXPERIMENTAL

Cenerimod

Intervention Type: DRUG

A single oral dose of 0.5 mg.

Group B: Participants with moderate hepatic impairment

Participants with moderate hepatic impairment (Child-Pugh Score of 7 to 9).

Group Type: EXPERIMENTAL

Cenerimod

Intervention Type: DRUG

A single oral dose of 0.5 mg.

Group C:Healthy participants

Healthy participants will be matched to the participants with hepatic impairment based on age and body weight.

Group Type: EXPERIMENTAL

Cenerimod

Intervention Type: DRUG

A single oral dose of 0.5 mg.

Interventions

Cenerimod

A single oral dose of 0.5 mg.

Intervention Type: DRUG

Other Intervention Names

ACT-334441

Eligibility Criteria

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.

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 79 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Viatris Innovation GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Viatris Innovation GmbH

Locations

CRU Hungary

Kistarcsa, , Hungary

BlueClinical Phase 1 Hospital de Prelado

Porto, , Portugal

Countries

Hungary; Portugal

Other Identifiers

2020-006002-23

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ID-064-106

Identifier Type: -

Identifier Source: org_study_id