HealthyPhase 1NCT04819464
A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of a Single Dose of Cenerimod
A Phase 1 study testing Cenerimod in people with Healthy and Hepatic Impairment, run by Viatris Innovation GmbH at 2 sites in 2 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hepatic Impairment
- What is being tested?
- Cenerimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Aug 2021to 18 Aug 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
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
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
- Being tested
- Cenerimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenerimodDrug
Also called ACT-334441
A single oral dose of 0.5 mg.
| Study group | Role | What they receive |
|---|---|---|
| Group A: Participants with mild hepatic impairment | Experimental | Participants with mild hepatic impairment (Child-Pugh Score of 5 to 6). Receives: Drug: Cenerimod |
| Group B: Participants with moderate hepatic impairment | Experimental | Participants with moderate hepatic impairment (Child-Pugh Score of 7 to 9). Receives: Drug: Cenerimod |
| Group C:Healthy participants | Experimental | Healthy participants will be matched to the participants with hepatic impairment based on age and body weight. Receives: Drug: Cenerimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration-time curves (AUC0-t): cenerimod
Measured: 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
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Maximum plasma concentration (Cmax): cenerimod.
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Time to reach Cmax (tmax): cenerimod
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Terminal half-life (t½): cenerimod
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Plasma protein binding of cenerimod
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Apparent clearance (CL/F) of cenerimod
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Apparent volume of distribution (Vz/F) of cenerimod
Measured: Multiple pharmacokinetic sampling at predefined times on Day 1 (pre-dose) up to Day 98.
Secondary outcomes (6)
Total lymphocyte count
Measured: 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
Measured: Pre-defined times on Day 1 (pre-dose) up to Day 105.
Change from baseline in body weight
Measured: Day -1 and Day 105.
Change from baseline in systolic and diastolic blood pressure (in the supine position)
Measured: Predefined times on Day 1 (pre-dose) up to Day 105.
Incidence of abnormal laboratory test results
Measured: Multiple sampling at predefined times on Day 1 (pre-dose) up to Day 105.
Adverse events and serious adverse events
Measured: Day 1 up to Day 105.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2021
- Study start25 Aug 2021
- Primary completion18 Aug 2024
- Study completion18 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- The 3 groups will be sequentially studied. Dosing will start in the participants with mild hepatic impairment.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viatris Innovation GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Viatris Innovation GmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819464
- Sponsor's protocol ID
- ID-064-106
- Other IDs
- 2020-006002-23
- Status last verified
- Sep 2024
- First submitted
- 16 Mar 2021
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04819464
- Acronym / sponsor ID
- ID-064-106
- Conditions
- Healthy, Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 25 Aug 2021 (actual)
- Primary completion
- 18 Aug 2024 (actual)
- Study completion
- 18 Aug 2024 (actual)
- First posted
- 29 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The 3 groups will be sequentially studied. Dosing will start in the participants with mild hepatic impairment.
| Arm | Type | Receives |
|---|---|---|
| Group A: Participants with mild hepatic impairment | Experimental | Drug: CenerimodParticipants with mild hepatic impairment (Child-Pugh Score of 5 to 6). |
| Group B: Participants with moderate hepatic impairment | Experimental | Drug: CenerimodParticipants with moderate hepatic impairment (Child-Pugh Score of 7 to 9). |
| Group C:Healthy participants | Experimental | Drug: CenerimodHealthy participants will be matched to the participants with hepatic impairment based on age and body weight. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CenerimodAlso: ACT-334441A single oral dose of 0.5 mg. | Drug | Group A: Participants with mild hepatic impairment, Group B: Participants with moderate hepatic impairment, Group C:Healthy participants |
Primary outcome
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.
6 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Viatris Innovation GmbH
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cenerimod in people with Healthy and Hepatic Impairment, run by Viatris Innovation GmbH at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary, Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2025.