Liver study checks how cenerimod behaves in the body
NCT ID NCT04819464
First seen Jun 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This completed Phase 1 study looked at how a single 0.5 mg dose of the drug cenerimod is processed in 24 people — some with mild or moderate liver impairment and some healthy. The goal was to see if liver problems change drug levels or safety. Participants were monitored for side effects and drug concentration in the blood.
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 single 0.5 mg oral dose)
- What this could lead to
- If successful, this study could help doctors understand how to dose cenerimod safely for patients with liver problems.
- What could go wrong
- This is an early Phase 1 study with only 24 people, so results may not apply to everyone. It only tests a single dose, not long-term use.
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
-
24 people
The number who actually took part.
- Started
-
Aug 2021
- Finished
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Aug 2024
- 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 79 years
- Sex
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Anyone
- 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 participant prior to any study-mandated procedure. * Women of child bearing potential must have a negative serum pregnancy test at screening, a negative urine pregnancy test on Day -1, and must agree to consistently and correctly use a highly effective method of contraception (i.e., failure rate of less than 1%). * Women of non-childbearing potential must have a medical history of previous bilateral salpingectomy, salpingo-oophorectomy or hysterectomy, premature ovarian failure confirmed by a specialist gynecologist; or, be post-menopausal, defined as 12 consecutive months with amenorrhea prior to screening without alternative medical cause and confirmed with a follicle-stimulating hormone test. * Body mass index of 18.0 to 32.0 kg/m2 (inclusive) at screening. * Negative SARS-CoV-2-testing prior to Day -1 or documented vaccination against COVID-19 at least 3 months prior screening. * Ability to communicate well with the investigator, in a language understandable to the participant, and to understand and comply with the requirements of the study. Exclusion Criteria: General (Group A, B and C) * Pregnant or lactating women. * Participation in a clinical study involving study treatment administration within 30 days prior to screening or in more than 2 clinical studies within 1 year prior to screening. * Previous exposure to cenerimod. * History or clinical evidence of any disease and/or existence of any surgical or medical condition, which might interfere with the absorption, distribution, metabolism, elimination (ADME) of the study treatment except for those related to liver cirrhosis or appendectomy and herniotomy. * International Normalized Ratio greater than 2 at screening. * Encephalopathy grade greater than or equal to 1. * Clinically relevant abnormalities on a 12-lead ECG, recorded after 5 minutes in the supine position at screening and on Day 1 pre-dose. * Presence of herpes simplex, disseminated zoster, or other opportunistic infections. * Vaccination with live or live attenuated vaccines in the previous 4 weeks. * Previous treatment with antiarrhythmic medications of class Ia or III 2 weeks or 5 half-lives, whichever is longer, prior to study treatment administration. * Active retinopathy or macular edema at screening. * Severe chronic obstructive pulmonary disease at screening. * Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol. * Legal incapacity or limited legal capacity at screening. Additional exclusion criteria for participants with hepatic impairment (Group A and B) * Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening and on Day -1, except for those related to liver cirrhosis. Additional exclusion criteria for healthy subjects (Group C) * Clinically relevant findings in clinical laboratory tests (hematology, coagulation, clinical chemistry, and urinalysis) at screening and on Day -1. * 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) within 2 weeks or 5 t½ prior to study treatment administration, whichever is longer (excluding contraceptives and HRT). * Aspartate aminotransferase and alanine aminotransferase above the upper limit of normal.
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Conditions
The condition(s) this trial relates to.
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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BlueClinical Phase 1 Hospital de Prelado
Porto, 4250-449, Portugal
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CRU Hungary
Kistarcsa, H2143, Hungary
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