Liver function may change how this drug works
NCT ID NCT05661344
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study looks at how the drug BI 1015550 is absorbed and processed in the blood of people with mild or moderate liver problems compared to those with healthy livers. About 28 adults took a single dose and had blood samples taken over several days. The goal is to understand if liver impairment affects drug levels, which could guide future dosing recommendations.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BI 1015550 (Nerandomilast)
- What this could lead to
- If successful, this study could help doctors determine the right dose of BI 1015550 for patients with liver problems, making the drug safer and more effective.
- What could go wrong
- This is a very early, small study (28 people) focused on drug levels, not on treating any disease. Results may not apply to all patients, and the drug could still cause side effects.
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
-
28 people
The number who actually took part.
- Started
-
Feb 2023
- Finished
-
Sep 2023
- 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 applicable to all participants * Male or female participants * Age 18-79 years (inclusive) * Body Mass Index (BMI) of 18.5 to 35 kilogram per square meter (kg/m2) (inclusive) * Signed and dated written informed consent in accordance with Guideline for Guideline for Good Clinical Practice - Good Clinical Practice (ICH-GCP) and local legislation prior to admission to the trial * Male participants are not required to use contraception * Women of childbearing potential are allowed to participate provided they use a highly effective contraception from at least 30 days before the administration of trial medication until 7 days after trial completion. Of note, oral hormonal contraceptives are not considered as highly effective in this study due to the potential CYP3A induction by BI 1015550. Methods of contraception considered adequate for female participants of childbearing potential are listed in the protocol. Inclusion criteria applying only to participants with impaired hepatic function * Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points) * further inclusion criteria apply Inclusion criteria applying only to participants with normal hepatic function * Individually matched to participants with hepatic impairment according to sex, age, and weight * further inclusion criteria apply Exclusion criteria applying to all participants * Any evidence of a concomitant disease assessed as clinically relevant by the investigator * Cholecystectomy or other surgery of the gastrointestinal tract that could interfere with the pharmacokinetic(s) (PK) of the trial medication (except appendectomy or simple hernia repair) * Diseases of the central nervous system (CNS) (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders (including but not limited to major depressive disorder) * History of relevant orthostatic hypotension, fainting spells, or blackouts * Relevant chronic or acute infections * Any documented active or suspected malignancy or history of malignancy within 5 years prior to screening, except appropriately treated basal cell carcinoma of the skin or squamous cell carcinoma in situ of the skin or in situ carcinoma of uterine cervix * further exclusion criteria apply Exclusion criteria applying only to participants with hepatic impairment * A marked prolongation of time from the start of the Q wave to the end of the T wave (QT)/ QT corrected for heart rate (QTc) interval (such as QT Corrected by the Fridericia Formula (QTcF) intervals that are repeatedly greater than 480 milliseconds (ms) in males or repeatedly greater than 500 ms in females) or any other relevant Electrocardiogram (ECG) finding at screening * further exclusion criteria apply Exclusion criteria applying only to participants with normal hepatic function * Any finding in the medical examination (including blood pressure (BP), pulse rate (PR) or ECG) deviating from normal and assessed as clinically relevant by the investigator * further exclusion criteria 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, 24105, Germany
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Other studies related to the condition(s) this trial covers.
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