Healthy SubjectsPhase 1NCT02914223
A Study to Evaluate Cenerimod in Healthy Male Subjects
A Phase 1 study testing Cenerimod in people with Healthy Subjects, run by Viatris Innovation GmbH at 1 site in Netherlands.
Trial summary
The main objective of the study is to investigate the rate and routes of elimination of cenerimod and the mass balance in urine, feces, and expired air Read more about this study
- Who is it for?
- Ages 45 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- 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
- 6 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2016to 1 Dec 2016
- 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 45 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Healthy male subjects aged between 45 and 65 years (inclusive) at screening
- No clinically significant findings on the physical examination at screening
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
- Systolic blood pressure (SBP) 100-145 mmHg and diastolic blood pressure (DBP) 50-90 mmHg, measured on either arm, after 5 min in the supine position at screening and at Day 1 pre-dose
- Heart rate (HR) 55-90 bpm (inclusive) measured with 12-lead ECG after 5 min in the supine position at screening and at Day 1 pre-dose
Who cannot join
- Known hypersensitivity to cenerimod or to S1P receptor modulators, or to any excipients of the cenerimod drug formulation
- 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- History or clinical evidence suggestive of active or latent tuberculosis including a positive QuantiFERON®-TB test at screening
- Any cardiac condition or illness (including 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on the standard 12-lead ECG at screening and at Day 1 pre-dose
- Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv)
- Any circumstances or conditions, which, in the opinion of the investigator, may affect the subject's full participation in the study or compliance with the protocol
- Any immunosuppressive treatment within 6 weeks or within 5 elimination half-lives of the immunosuppressive treatment, whichever is longer, before study treatment administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single-center, Open-label Study With 14C-radiolabeled Cenerimod to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
The main objective of the study is to investigate the rate and routes of elimination of cenerimod and the mass balance in urine, feces, and expired air
- Conditions
- Healthy Subjects
- Being tested
- Cenerimod
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CenerimodDrug
Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod
| Study group | Role | What they receive |
|---|---|---|
| Treatment and observation period | Experimental | On Day 1, subjects will receive a single oral dose of 2 mg 14C-radiolabeled cenerimod. Subjects will be followed for 21 days during which blood, urine, feces, and expired air samples will be collected Receives: Drug: Cenerimod |
| Extended observation period | Experimental | In case, radioactivity recovery does not meet the stopping criteria described in the protocol, the subjects will have to come for a maximum of 7 24-h in-clinic visits during which blood, urine, feces, and expired air samples will be collected Receives: Drug: Cenerimod |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative excretion calculated by summing up the daily radioactivity excretion measured by means of liquid scintillation counting in urine, feces, and expired air (if applicable)
Measured: From baseline up to a maximum of 99 days
Secondary outcomes (9)
Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma
Cmax is derived from the observed plasma concentration-time curves
Measured: From baseline up to a maximum of 99 days
tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma
Tmax is derived from the observed plasma concentration-time curves
Measured: From baseline up to a maximum of 99 days
t1/2 (terminal half-life)
Measured: From baseline up to a maximum of 99 days
Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma
AUC is defined for the time intervals from zero to time t of the last measured concentration above the limit of quantification and from zero to infinity
Measured: From baseline up to a maximum of 99 days
Incidence of safety events of interest
Events of interest are any abnormalities in ECG, vital signs or laboratory test results
Measured: From baseline up to a maximum of 99 days
Number of participants with adverse events (AEs)
Treatment-emergent AEs and treatment emergent serious AEs
Measured: From baseline up to a maximum of 99 days
Cenerimod metabolites profiling in plasma
Relative abundance expressed as percent of cenerimod
Measured: From baseline up to a maximum of 99 days
Cenerimod metabolites profiling in urine
Relative abundance expressed as percent of cenerimod
Measured: From baseline up to a maximum of 99 days
Cenerimod metabolites profiling in feces
Relative abundance expressed as percent of cenerimod
Measured: From baseline up to a maximum of 99 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start1 Sep 2016
- Primary completion1 Dec 2016
- Study completion1 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 6 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
- NCT02914223
- Sponsor's protocol ID
- AC-064-103
- Status last verified
- Jul 2018
- First submitted
- 13 Sep 2016
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- 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
- Single-center, Open-label Study With 14C-radiolabeled Cenerimod to Investigate the Mass Balance, Pharmacokinetics, and Metabolism Following Single Oral Administration to Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT02914223
- Acronym / sponsor ID
- AC-064-103
- Conditions
- Healthy Subjects
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2016
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Dec 2016 (actual)
- First posted
- 26 Sep 2016 (estimated)
- 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.
The main objective of the study is to investigate the rate and routes of elimination of cenerimod and the mass balance in urine, feces, and expired air
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment and observation period | Experimental | Drug: CenerimodOn Day 1, subjects will receive a single oral dose of 2 mg 14C-radiolabeled cenerimod. Subjects will be followed for 21 days during which blood, urine, feces, and expired air samples will be collected |
| Extended observation period | Experimental | Drug: CenerimodIn case, radioactivity recovery does not meet the stopping criteria described in the protocol, the subjects will have to come for a maximum of 7 24-h in-clinic visits during which blood, urine, feces, and expired air samples will be collected |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure
- Healthy male subjects aged between 45 and 65 years (inclusive) at screening
- No clinically significant findings on the physical examination at screening
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 (inclusive) at screening
- Systolic blood pressure (SBP) 100-145 mmHg and diastolic blood pressure (DBP) 50-90 mmHg, measured on either arm, after 5 min in the supine position at screening and at Day 1 pre-dose
Key exclusion criteria (7 listed)
- Known hypersensitivity to cenerimod or to S1P receptor modulators, or to any excipients of the cenerimod drug formulation
- 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 (appendectomy and herniotomy allowed, cholecystectomy not allowed)
- History or clinical evidence suggestive of active or latent tuberculosis including a positive QuantiFERON®-TB test at screening
- Any cardiac condition or illness (including 12-lead ECG abnormalities) with a potential to increase the cardiac risk of the subject based on the standard 12-lead ECG at screening and at Day 1 pre-dose
- Participation in another study with a radiation burden of > 0.1 mSv and ≤ 1 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv)
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 |
|---|---|---|
| CenerimodOral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod | Drug | Extended observation period, Treatment and observation period |
Primary outcome
Cumulative excretion calculated by summing up the daily radioactivity excretion measured by means of liquid scintillation counting in urine, feces, and expired air (if applicable)
Time frame: From baseline up to a maximum of 99 days
9 secondary outcomes
Cmax (maximum plasma concentration) of 14C-radioactivity in whole blood and plasma
Time frame: From baseline up to a maximum of 99 days
tmax (time to reach Cmax) of 14C-radioactivity in whole blood and plasma
Time frame: From baseline up to a maximum of 99 days
t1/2 (terminal half-life)
Time frame: From baseline up to a maximum of 99 days
Area under the plasma concentration-time curve (AUC) of 14C-radioactivity in whole blood and plasma
Time frame: From baseline up to a maximum of 99 days
Incidence of safety events of interest
Time frame: From baseline up to a maximum of 99 days
Number of participants with adverse events (AEs)
Time frame: From baseline up to a maximum of 99 days
Cenerimod metabolites profiling in plasma
Time frame: From baseline up to a maximum of 99 days
Cenerimod metabolites profiling in urine
Time frame: From baseline up to a maximum of 99 days
Cenerimod metabolites profiling in feces
Time frame: From baseline up to a maximum of 99 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.
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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 Subjects, run by Viatris Innovation GmbH at 1 site in Netherlands.
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 7 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 Netherlands. 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?
Cumulative excretion calculated by summing up the daily radioactivity excretion measured by means of liquid scintillation counting in urine, feces, and expired air (if applicable) (time frame: From baseline up to a maximum of 99 days). 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.