Healthy men swallow drug, get radioactive tracer to measure absorption
NCT ID NCT07301723
First seen Jun 27, 2026 · Last updated Jul 15, 2026 · Updated 2 times
Summary
This study measured how much of the drug cenerimod gets into the blood after swallowing a tablet. Six healthy men took one pill, then received a tiny radioactive version of the drug through a vein. They stayed at the clinic for 4 days and returned for checkups over 3 months. The goal was purely to understand the drug's absorption, not to treat any disease.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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6 people
The number who actually took part.
- Started
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Dec 2025
- Finished
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Mar 2026
- Lead sponsor
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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
-
18 to 65 years
- Sex
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Male participants only
- Healthy volunteers
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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: 1. Signed and dated informed consent form in a language understandable to the participant prior to any trial-mandated procedure. 2. 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. 3. Body mass index 18.0-29.9 kg/m\^2 (inclusive) at Screening. 4. Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the trial requirements. 5. 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. 6. 12-lead safety ECG: QTcF \< 450 ms, QRS interval \< 120 ms, PR interval \< 200 ms, and heart rate 55-100 bpm, and without clinically relevant abnormalities, measured after 5 min in the supine position at Screening and prior to oral dosing on the day of study treatment administration. Main Exclusion Criteria: 1. Previous exposure to cenerimod. 2. Known hypersensitivity to any excipients of the trial intervention formulations. 3. Known hypersensitivity or allergy to natural rubber latex. 4. History of major medical or surgical disorders which, in the opinion of the investigator, are likely to interfere with the absorption, distribution, metabolism, or excretion of the trial interventions (appendectomy and herniotomy allowed, cholecystectomy not allowed). 5. Acute, ongoing, recurrent, or chronic systemic disease able to interfere with the evaluation of the trial results. 6. Clinically relevant history of fainting, collapse, syncope, orthostatic hypotension, or vasovagal reactions. 7. Lymphopenia (\< 0.9 x 10\^9 cells/L) at Screening or on the day prior to study treatment administration. 8. Family history of sick-sinus syndrome. 9. Any cardiac condition or illness (including ECG abnormalities) with a potential to increase the cardiac risk of the participant based on the standard 12-lead ECG at Screening or pre-dose on the day of study treatment administration. 10. History or presence of cardiac rhythm disorders (e.g., sinoatrial heart block, sick-sinus syndrome, 2nd or 3rd degree atrioventricular block, long QT syndrome, symptomatic bradycardia, atrial flutter, or atrial fibrillation). 11. Previous treatment with antiarrhythmic medications of class Ia or III within 2 weeks or 5 elimination half-lives, whichever is longer, prior to oral dosing. 12. Clinically relevant findings in clinical laboratory tests (hematology, clinical chemistry, and urinalysis) at Screening or on the day prior to 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
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Pharmaceutical Research Associates Group B.V.
Groningen, 9728, Netherlands
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