Healthy men help scientists track how cenerimod exits the body
NCT ID NCT02914223
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study gave a single dose of a radiolabeled drug called cenerimod to 6 healthy men aged 45-65. The goal was to see how quickly and by what routes (urine, feces, breath) the drug leaves the body. It is a Phase 1 trial with no treatment benefit, purely to gather information for future research.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- cenerimod (a drug being tested for immune-related conditions)
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
6 people
The number who actually took part.
- Start date
-
Sep 2016
- Finished
-
Dec 2016
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
45 to 65 years
- Sex
-
Male participants only
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
PRA Health Science
Groningen, 9728 NZ, Netherlands
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