Healthy VolunteersPhase 1NCT04052360
Single Oral Dose of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects
A Phase 1 study testing Cenerimod in people with Healthy Volunteers, run by Viatris Innovation GmbH at 1 site in United States.
Trial summary
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian participants. Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Cenerimod
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2019to 2 Nov 2019
- 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
- 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.
- Body mass index of 18.0 to 28.0 kg/m^2 (inclusive) at the screening.
- Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
- No clinically relevant findings on the physical examination at screening.
- Systolic blood pressure 100 to 145 mmHg, diastolic blood pressure 50 to 90 mmHg, and pulse rate 55 to 90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on admission.
- 12-lead ECG without clinically relevant abnormalities, measured after 5 min in the supine position at Screening and on admission.
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- No clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at screening and on admission.
- Negative results from urine drug screen and breath alcohol tests at screening and on admission.
- Subjects must be of Caucasian or Japanese ethnicity.
Who cannot join
- Previous exposure to cenerimod.
- Known hypersensitivity or allergy to natural rubber latex, to or any of the excipients.
- History of major medical or surgical disorders which are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation.
- Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
- Lymphopenia (less than 1.0 x 10^9 cells/L) at screening and on admission.
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- Familial history of sick-sinus syndrome.
- Any cardiac condition or illness (including Electrocardiogram (ECG) abnormalities with a potential to increase the cardiac risk.
- Familial history of sick-sinus syndrome.
- Any recent immunosuppressive treatment.
- History or clinical evidence of alcoholism or drug abuse.
- Excessive caffeine consumption, defined as 800 mg or more per day at screening.
- Nicotine consumption within 3 months prior to screening and inability to refrain from nicotine consumption.
- 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).
- Viral, fungal, bacterial or protozoal infection and / or serology.
- Legal incapacity or limited legal capacity at screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Single-dose Administration of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects
This study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian participants in the other group.
The duration of participation in this study is approximately 75 days from screening to the end of study visit. A screening visit is required within 21 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 4 days (3 nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49 outpatient visit.
- Conditions
- Healthy Volunteers
- Being tested
- Cenerimod, Matching Placebo
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 4 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.
Matching PlaceboDrug
A single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.
| Study group | Role | What they receive |
|---|---|---|
| Cenerimod / ACT-334441 | Experimental | Not described Receives: Drug: Cenerimod |
| Matching Placebo | Placebo comparator | Not described Receives: Drug: Matching Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the plasma concentration-time curve (AUC) for cenerimod
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.
Measured: From Day 1 to Day 49
Secondary outcomes (4)
Maximum plasma concentration (Cmax) for cenerimod
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.
Measured: From Day 1 to Day 49
Time to reach the maximum plasma concentration (tmax) for cenerimod
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.
Measured: From Day 1 to Day 49
Terminal half-life [t(1/2)] of cenerimod
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.
Measured: From Day 1 to Day 49
Lymphocyte count
The lymphocyte count will be used as a measure of immunomodulation (a change in the body's immune system).
Measured: Day 1, Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 28, Day 35, Day 42 and Day 49
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2019
- Study start7 Aug 2019
- Primary completion29 Oct 2019
- Study completion2 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 20 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
- NCT04052360
- Sponsor's protocol ID
- ID-064-104
- Status last verified
- Apr 2020
- First submitted
- 8 Aug 2019
- Last updated
- 22 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- 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
- A Single-center, Double-blind, Placebo-controlled, Randomized Study to Investigate the Tolerability, Safety, Pharmacokinetics, and Pharmacodynamics After Single-dose Administration of 4 mg Cenerimod in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT04052360
- Acronym / sponsor ID
- ID-064-104
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Viatris Innovation GmbHIndustry (pharma, biotech, devices)
- Study start
- 7 Aug 2019 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 2 Nov 2019 (actual)
- First posted
- 9 Aug 2019 (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 study is for research purposes only and is not intended to treat any medical condition. The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of cenerimod following a single dose in healthy Japanese and Caucasian participants. Pharmacokinetics is the study of the absorption and breakdown of the study drug in the body. Pharmacodynamics is the study of the effect of the study drug on the body. There will be 2 groups in the study. 10 Japanese participants in one group and 10 Caucasian participants in the other group.
The duration of participation in this study is approximately 75 days from screening to the end of study visit. A screening visit is required within 21 days prior to the start of the study to determine whether the volunteer qualifies and is willing to participate in this research study. This study requires in-patient stay in the research clinic of 4 days (3 nights) followed by outpatient visits and an end of study visit 3 to 5 days after the day 49 outpatient visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cenerimod / ACT-334441 | Experimental | Drug: Cenerimod |
| Matching Placebo | Placebo comparator | Drug: Matching Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent in a language understandable to the subject prior to any study-mandated procedure.
- Body mass index of 18.0 to 28.0 kg/m^2 (inclusive) at the screening.
- Ability to communicate well with the investigator, in a language understandable to the subject, and to understand and comply with the requirements of the study.
- No clinically relevant findings on the physical examination at screening.
- Systolic blood pressure 100 to 145 mmHg, diastolic blood pressure 50 to 90 mmHg, and pulse rate 55 to 90 bpm (inclusive), measured on the same arm, after 5 min in the supine position at screening and on admission.
Key exclusion criteria (16 listed)
- Previous exposure to cenerimod.
- Known hypersensitivity or allergy to natural rubber latex, to or any of the excipients.
- History of major medical or surgical disorders which are likely to interfere with the absorption, distribution, metabolism, or excretion of the study treatment (appendectomy and herniotomy allowed, cholecystectomy not allowed).
- Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation.
- Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions.
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 4 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions. | Drug | Cenerimod / ACT-334441 |
| Matching PlaceboA single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions. | Drug | Matching Placebo |
Primary outcome
The area under the plasma concentration-time curve (AUC) for cenerimod
Time frame: From Day 1 to Day 49
The plasma PK parameter of cenerimod will be derived by non-compartmental analysis of plasma concentration-time profiles.
4 secondary outcomes
Maximum plasma concentration (Cmax) for cenerimod
Time frame: From Day 1 to Day 49
Time to reach the maximum plasma concentration (tmax) for cenerimod
Time frame: From Day 1 to Day 49
Terminal half-life [t(1/2)] of cenerimod
Time frame: From Day 1 to Day 49
Lymphocyte count
Time frame: Day 1, Day 3, Day 6, Day 9, Day 12, Day 15, Day 18, Day 21, Day 28, Day 35, Day 42 and Day 49
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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Screening Protocol
Pain
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 Volunteers, run by Viatris Innovation GmbH at 1 site in United States.
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 9 inclusion and 16 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 United States. 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. Some participants in this study may receive a placebo. 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?
The area under the plasma concentration-time curve (AUC) for cenerimod (time frame: From Day 1 to Day 49). 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.