Actively Recruiting
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
Led by Boehringer Ingelheim · Updated on 2026-04-29
32
Participants Needed
3
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 80 years at screening
- Body mass index (BMI) between 18.5 and 42 kg/m² (inclusive)
- Signed and dated written informed consent as per guidelines before joining the trial
- Female participants must use highly effective contraception methods from 30 days before dosing until 5 months after dosing, including combined hormonal contraception plus condom, progestogen-only contraception plus condom, intrauterine devices plus condom, sexual abstinence, vasectomised partner with medical confirmation, surgical sterilization plus condom, or be postmenopausal
- Participants with liver impairment must have Child-Pugh classification A (5-6 points), B (7-9 points), or C (10-15 points)
- No significant abnormalities except those consistent with liver impairment based on medical history, physical exam, vital signs, ECG, and lab tests at screening and admission
- Medication or treatment regimens stable for at least 7 days or 5 half-lives before randomization and maintained during the study
- Participants with normal liver function must be matched by sex, age, smoking habit, and weight to those with hepatic impairment
You will not qualify if you...
- Any medical condition or finding that poses a safety risk or interferes with study objectives, except related to hepatic impairment for those with liver issues
- Any laboratory value outside reference range considered clinically relevant except due to underlying disease
- Severe gastrointestinal, renal (eGFR <40 ml/min/1.73 m² for hepatic impaired; <60 ml/min/1.73 m² for controls), respiratory, cardiovascular, metabolic, immunological, or hormonal disorders deemed clinically relevant
- Alpha fetoprotein levels above 50 ng/mL at screening
- Gastrointestinal surgery that could affect medicine absorption, except cholecystectomy, appendectomy, or simple hernia repair
- Central nervous system diseases including seizures, stroke, or relevant neurological or psychiatric disorders
- History of orthostatic hypotension, fainting, or blackouts
- Relevant chronic or acute infections
- Additional exclusion criteria as applicable by investigators or protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
2
Tranquil Clinical Research
Houston, Texas, United States, 77598
Completed
3
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
B
Boehringer Ingelheim
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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