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A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems

Description

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood. Study participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons. Participants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.

Conditions

HealthyHepatic Impairment
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HealthyHepatic Impairment

Study Overview

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Study Details

Study overview

This study is open to adults aged between 18 and 80 years of age with a body mass index (BMI) of 18.5 to 42 kg/m². People with or without liver problems can take part in the study. The purpose of this study is to find out how much of a medicine called BI 1291583 gets into the blood of people with and without liver problems. BI 1291583 is being developed to treat people with bronchiectasis, a chronic disease of the lungs. People living with this condition often also have liver problems. Therefore, it is important to find out whether liver problems influence the amount of BI 1291583 that gets into the blood. Study participants receive a single dose of BI 1291583 as a tablet taken by mouth. Participants are divided into 4 groups based on how well their liver works: 1 group without liver problems, and 3 groups with mild, moderate, and severe liver problems. Each participant without liver problems is matched with participants from the other groups based on factors such as age, sex, smoking habits, and body weight to ensure accurate comparisons. Participants are in the study for about 3 months. They stay for 3 days at the study site and also visit the study site up to 9 times. During these visits, the doctors collect information about participants' health. To assess the study endpoints, the doctors regularly take blood samples from the participants. The doctors regularly check participants' health and take note of any unwanted effects.

Open Label, Single Dose, Parallel-group Study to Evaluate the PK and the Safety and Tolerability of Single Oral Doses of BI 1291583 in Trial Participants With Mild, Moderate and Severe Hepatic Impairment as Compared to Matched, Hepatically Healthy Trial Participants.

A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems

Condition
Healthy
Intervention / Treatment

-

Contacts and Locations

Orlando

Orlando Clinical Research Center, Orlando, Florida, United States, 32809

Houston

Tranquil Clinical Research, Houston, Texas, United States, 77598

San Antonio

American Research Corporation at the Texas Liver Institute, San Antonio, Texas, United States, 78215

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Any medical condition or finding in the medical examination that in the investigator's opinion assessed as clinically relevant, poses a safety risk for the trial participant or may interfere with the study objectives (except for conditions associated with hepatic impairment in trial participant with compromised hepatic function)
  • 2. Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)
  • 3. Severe gastrointestinal, renal (estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology (CKD-EPI) \<40 ml/min/1.73 m2 for the hepatic impaired trial participants and Estimated Glomerular Filtration Rate (eGFR) Chronic Kidney Disease Epidemiology (CKD-EPI) \<60 ml/min/1.73 m2 for matched controls), respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessed as clinically relevant by the Investigator
  • 4. Alpha fetoprotein \>50 ng/mL (\>50 µg/L) at screening
  • 5. Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair)
  • 6. Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
  • 7. History of relevant orthostatic hypotension, fainting spells, or blackouts
  • 8. Relevant chronic or acute infections
  • 9. Further exclusion criteria apply

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Boehringer Ingelheim,

Study Record Dates

2026-03-20