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Early safety check for cenerimod in healthy people

NCT ID NCT04052360

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This early-stage study tested a single 4 mg dose of the drug cenerimod in 20 healthy volunteers (10 Japanese and 10 Caucasian). The goal was not to treat any disease but to see how safe the drug is and how the body absorbs and breaks it down. Participants stayed in the clinic for 4 days and had follow-up visits over about 75 days.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
cenerimod

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

20 people

The number who actually took part.

Started

Aug 2019

Finished

Nov 2019

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

18 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

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. * 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. * 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. Exclusion Criteria: * 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. * 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.

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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

  • Anaheim Clinical Trials

    Anaheim, California, 92801, United States

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