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

NCT04819464 | Completed Phase 1

• 2 other identifiers: ID-064-1062020-006002-23
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 2

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

Outcome Measures

Primary Outcomes (8)

• Area under the plasma concentration-time curves (AUC0-t): cenerimod

  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

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

• Maximum plasma concentration (Cmax): cenerimod.

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

• Time to reach Cmax (tmax): cenerimod

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

• Terminal half-life (t½): cenerimod

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

• Plasma protein binding of cenerimod

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

• Apparent clearance (CL/F) of cenerimod

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

• Apparent volume of distribution (Vz/F) of cenerimod

  Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.

Secondary Outcomes (6)

• Total lymphocyte count

  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

  Pre-defined times on Day 1 (pre-dose) up to Day 105.

• Change from baseline in body weight

  Day -1 and Day 105.

• Change from baseline in systolic and diastolic blood pressure (in the supine position)

  Predefined times on Day 1 (pre-dose) up to Day 105.

• Incidence of abnormal laboratory test results

  Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 105.

Study Arms (3)

Group A: Participants with mild hepatic impairment

EXPERIMENTAL

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

Drug: Cenerimod

Group B: Participants with moderate hepatic impairment

EXPERIMENTAL

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

Drug: Cenerimod

Group C:Healthy participants

EXPERIMENTAL

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

Drug: Cenerimod

Interventions

Cenerimod DRUG

A single oral dose of 0.5 mg.

Also known as: ACT-334441

Group A: Participants with mild hepatic impairment; Group B: Participants with moderate hepatic impairment; Group C:Healthy participants

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Viatris Innovation GmbH: lead

Study Sites (2)

CRU Hungary

Kistarcsa, H2143, Hungary

Location

BlueClinical Phase 1 Hospital de Prelado

Porto, 4250-449, Portugal

Location

MeSH Terms

Interventions

cenerimod

Study Officials

• Clinical Trials

  Viatris Innovation GmbH

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The 3 groups will be sequentially studied. Dosing will start in the participants with mild hepatic impairment.

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 29, 2021
• Study Start: August 25, 2021
• Primary Completion: August 18, 2024
• Study Completion: August 18, 2024
• Last Updated: September 22, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1); PT (1)