Liver function may change how evobrutinib works in the body
NCT ID NCT04546789
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at how different levels of liver impairment affect the way the body processes a single dose of the drug evobrutinib. Twenty-four participants with either normal liver function or mild to moderate liver impairment took one dose of the drug. Researchers measured drug levels in the blood and monitored safety. The goal was to understand if liver problems require dose adjustments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- evobrutinib (a BTK inhibitor drug)
- What this could lead to
- If successful, this could help doctors decide the right dose of evobrutinib for people with liver problems.
- What could go wrong
- This is a very early, small study (24 people) focused on drug processing, not on treating a disease. Results may not apply to long-term use or to broader populations.
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
-
Sep 2020
- Finished
-
May 2021
- 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
-
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: * Participants with normal hepatic function only will be overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures, or completion OR * Participants with moderately impaired hepatic function only will be considered to have moderately (Child-Pugh class B and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to Screening OR * Participants with mildly impaired hepatic function only will be considered to have mildly (Child-Pugh class A and confirmed liver cirrhosis) impaired hepatic function and has been clinically stable for at least 1 month prior to Screening * Have a body weight within 50.0 and 120.0 kilogram (kg) and body mass index (BMI) within the range 19.0 and 36.0 kilogram per square meter (kg/m\^2) * Female participants are not pregnant or breastfeeding, and at least one of the following conditions applies * Not a woman of childbearing potential (WOCBP) * Other protocol defined inclusion criteria could apply Exclusion Criteria: * Clinical history of autoimmune disorder with hepatic influence (Hashimoto thyroiditis and rheumatic diseases allowed) * History of any malignancy * Diseases and surgeries of the gastrointestinal tract, which could influence the gastrointestinal anatomy and mobility. Prior history of cholecystectomy or inflammatory bowel disease, and any clinically relevant surgery within 6 months prior to Screening * History of chronic or recurrent acute infection or any bacterial, viral, parasitic or fungal infections within 30 days prior to Screening and at any time between Screening and admission, or hospitalization due to infection within 6 months prior to Screening * History of shingles within 12 months prior to Screening * History of drug hypersensitivity, ascertained or presumptive allergy/hypersensitivity to the active drug substance and/or formulation ingredients; history of serious allergic reactions leading to hospitalization or any other hypersensitivity reaction in general, which may affect the safety of the participant and/or outcome of the trial per the Investigator's discretion * Participants with impaired hepatic function will be excluded who had Primary and secondary biliary cirrhosis. * Participants with impaired hepatic function will be excluded with Clinical evidence of severe ascites. * Participants with impaired hepatic function will be excluded with Hepatic encephalopathy Grade greater than 1 * Other protocol defined exclusion criteria could apply
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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
-
CRS Clinical Research Services Kiel GmbH
Kiel, Germany
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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