CompletedPhase 1

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants

Netherlands6 participantsStarted 2025-12-11

Plain-language summary

The goal of this clinical trial is to learn about the absolute bioavailability of cenerimod in healthy participants. It will also provide information about the safety of cenerimod. Participants will receive one tablet with cenerimod, followed by an intravenous (i.v.) infusion with a 14C-radiolabeled cenerimod microtracer (cenerimod with a very low dose of radioactivity) 6 hours later. Participants will stay at the clinic for a total of 4 days, and will return to the clinic for further tests over the course of approximately 3 months.

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed and dated informed consent form in a language understandable to the participant prior to any trial-mandated procedure.
. Healthy male participant aged between 18 and 65 years (inclusive) at Screening. Healthy is defined as no clinically relevant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations.
. Body mass index 18.0-29.9 kg/m\^2 (inclusive) at Screening.
. Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the trial requirements.
. Systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, and pulse rate 55-100 bpm (inclusive), measured on either arm (same arm used for both Screening and on the day of study treatment administration), after 5 min in the supine position at Screening and prior to oral dosing on the day of study treatment administration.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Absolute bioavailability

Timeframe: Up to 98 days post-dose

Trial details

NCT IDNCT07301723

SponsorViatris Innovation GmbH

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-03-18

View on ClinicalTrials.gov More Healthy Subjects trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Signed and dated informed consent form in a language understandable to the participant prior to any trial-mandated procedure.
. Healthy male participant aged between 18 and 65 years (inclusive) at Screening. Healthy is defined as no clinically relevant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital signs measurements, and clinical laboratory evaluations.
. Body mass index 18.0-29.9 kg/m\^2 (inclusive) at Screening.
. Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the trial requirements.
. Systolic blood pressure 90-140 mmHg, diastolic blood pressure 60-90 mmHg, and pulse rate 55-100 bpm (inclusive), measured on either arm (same arm used for both Screening and on the day of study treatment administration), after 5 min in the supine position at Screening and prior to oral dosing on the day of study treatment administration.

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

A Trial to Evaluate the Absolute Bioavailability of Cenerimod in Healthy Male Participants

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria