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Liver function may change how this drug works

NCT ID NCT05661344

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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.

Hepatic Insufficiency liver disorder liver failure

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.