HealthyPhase 1NCT05004311
The Effect of Severe Kidney Impairment on Cenerimod Pharmacokinetics
A Phase 1 study testing Cenerimod in people with Healthy and Renal Impairment, run by Viatris Innovation GmbH at 1 site in Portugal.
Trial summary
To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Renal 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
- 16 participants
- Where
- 1 sitePortugal
- Study dates
- 27 Sep 2021to 10 Aug 2023
- 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 65 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 childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use a highly effective method of contraception.
- Women of non-childbearing potential.
- Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at Screening
- Negative SARS-CoV-2 reverse transcription polymerase chain reaction test on Day -1.
- Additional inclusion criteria for participants with severe renal impairment
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- Estimated glomerular filtration rate (eGFR) at screening using the Modification of Diet in Renal Disease formula less-than 30 mL/min/1.73 m2 for participants with renal impairment. The eGFR value should be confirmed on Day -1.
- Systolic blood pressure (SBP) 100 to 180 mmHg, diastolic BP (DBP) 50 to 105 mmHg, and pulse rate 60 to 100 bpm (inclusive), on Day 1 pre-dose.
- Stable concomitant medications for at least 3 weeks prior to screening and up to Day 1.
- Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinanalysis) except for those related to renal impairment at Screening and on Day-1.
- Additional inclusion criteria for control participants
- eGFR at Screening using the Modification of Diet in Renal Disease formula of ≥ 90 mL/min/1.73 m2.
- SBP 90 to 139 mmHg, DBP 60 to 89 mmHg, and pulse rate 60 to 99 bpm, measured on the same arm, after 5 min in the supine position at screening and on Day 1 pre-dose.
Who cannot join
- Pregnant or lactating women.
- Participation in a clinical study involving study treatment administration within 3 months prior to screening or participation in more than 2 clinical studies within 1 year prior to Screening.
- Previous exposure to cenerimod.
- Known hypersensitivity to any excipients of the treatment formulation.
- Clinically relevant abnormalities on a 12-lead electrocardiogram at Screening and Day -1.
- Previous treatment with anti-arrhythmic medications of class Ia or III within 2 weeks or 5 half-lives, whichever is longer, prior to study treatment administration.
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- History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, or excretion of the study treatment except for renal disease, appendectomy, herniotomy, or cholecystectomy.
- Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
- Legal incapacity or limited legal capacity at Screening.
- Additional exclusion criteria for participants with severe renal impairment:
- Presence of severe cardiac disease.
- End-stage renal disease that requires dialysis.
- History of severe renal artery stenosis.
- Serum potassium concentration > 5.5 mmol/L.
- Presence of unstable diabetes mellitus.
- Strict fluid restriction.
- Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) except for those related to renal impairment at Screening and on Day -1.
- Additional exclusion criteria for control participants
- Clinically relevant findings on the physical examination at Screening.
- Clinically relevant findings in clinical laboratory tests.
Trial locations and contacts
1 site in 1 country.
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 Severe Renal Impairment and Control Subjects
To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
- Conditions
- Healthy, Renal Impairment
- Being tested
- Cenerimod
- Medical subject headings
- Renal Insufficiency
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 cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions
| Study group | Role | What they receive |
|---|---|---|
| Group A (severe renal function impairment) | Experimental | Eight (8) participants with severe renal impairment. Receives: Drug: Cenerimod |
| Group B (healthy) | Experimental | Eight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A. 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 curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod
Measured: Total duration: up to 52 days
Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod
Measured: Total duration: up to 52 days
The maximum plasma concentration (Cmax) of cenerimod
Measured: Total duration: up to 52 days
The time to reach Cmax (tmax) of cenerimod
Measured: Total duration: up to 52 days
Terminal half-life (t½) of cenerimod
Measured: Total duration: up to 52 days
Apparent oral clearance (CL/F) of cenerimod
Measured: Total duration: up to 52 days
Extent of cenerimod protein plasma binding (PPB)
Measured: Total duration: up to 52 days
Apparent volume of distribution (Vz/F) of cenerimod
Measured: Total duration: up to 52 days
Secondary outcomes (5)
Total lymphocyte count count.
Measured: Total duration: up to 66 days
Change from baseline at each time point of measurement in electrocardiogram QT interval
Measured: Total duration: up to 66 days
Change from baseline in body weight
Measured: Total duration: up to 66 days
Change from baseline in systolic and diastolic blood pressure (in the supine position)
Measured: Total duration: up to 66 days
Incidence of abnormal laboratory test results
Measured: Total duration: up to 66 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start27 Sep 2021
- Primary completion27 Jul 2023
- Study completion10 Aug 2023
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 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
- NCT05004311
- Sponsor's protocol ID
- ID-064-107
- Other IDs
- 2021-001522-21
- Status last verified
- Aug 2023
- First submitted
- 3 Aug 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 Severe Renal Impairment and Control Subjects
- ClinicalTrials.gov ID
- NCT05004311
- Acronym / sponsor ID
- ID-064-107
- Conditions
- Healthy, Renal Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 13 Aug 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.
To investigate the PK of cenerimod in participants with severe renal impairment as compared to healthy control participants.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (severe renal function impairment) | Experimental | Drug: CenerimodEight (8) participants with severe renal impairment. |
| Group B (healthy) | Experimental | Drug: CenerimodEight (8) control participants, matched to the 8 severe renal impaired participants enrolled in Group A. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Signed informed consent in a language understandable to the participant prior to any study-mandated procedure.
- Women of childbearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on Day -1, and agree to consistently and correctly use a highly effective method of contraception.
- Women of non-childbearing potential.
- Body mass index of 18.0 to 35.0 kg/m2 (inclusive) at Screening
- Negative SARS-CoV-2 reverse transcription polymerase chain reaction test on Day -1.
Key exclusion criteria (20 listed)
- Pregnant or lactating women.
- Participation in a clinical study involving study treatment administration within 3 months prior to screening or participation in more than 2 clinical studies within 1 year prior to Screening.
- Previous exposure to cenerimod.
- Known hypersensitivity to any excipients of the treatment formulation.
- Clinically relevant abnormalities on a 12-lead electrocardiogram at Screening and Day -1.
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 cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions | Drug | Group A (severe renal function impairment), Group B (healthy) |
Primary outcome
Area under the plasma concentration-time curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod
Time frame: Total duration: up to 52 days
Area under the plasma concentration-time curve (AUC from 0 to infinity) of cenerimod
Time frame: Total duration: up to 52 days
The maximum plasma concentration (Cmax) of cenerimod
Time frame: Total duration: up to 52 days
The time to reach Cmax (tmax) of cenerimod
Time frame: Total duration: up to 52 days
Terminal half-life (t½) of cenerimod
Time frame: Total duration: up to 52 days
Apparent oral clearance (CL/F) of cenerimod
Time frame: Total duration: up to 52 days
Extent of cenerimod protein plasma binding (PPB)
Time frame: Total duration: up to 52 days
Apparent volume of distribution (Vz/F) of cenerimod
Time frame: Total duration: up to 52 days
5 secondary outcomes
Total lymphocyte count count.
Time frame: Total duration: up to 66 days
Change from baseline at each time point of measurement in electrocardiogram QT interval
Time frame: Total duration: up to 66 days
Change from baseline in body weight
Time frame: Total duration: up to 66 days
Change from baseline in systolic and diastolic blood pressure (in the supine position)
Time frame: Total duration: up to 66 days
Incidence of abnormal laboratory test results
Time frame: Total duration: up to 66 days
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
1 site in 1 country: 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 Renal Impairment, run by Viatris Innovation GmbH at 1 site in Portugal.
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 14 inclusion and 20 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 1 site in 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 curve (AUC) from time zero to time t of the last measured concentration above the limit of quantification (AUC0-t) of cenerimod (time frame: Total duration: up to 52 days). 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.