Study of BI 1291583 in People With and Without Liver Problems

This study is looking at a medicine called BI 1291583, which is being developed to treat a lung condition called bronchiectasis. Many people with bronchiectasis also have liver problems. The main goal of this study is to see how much of BI 1291583 gets into the blood of people with and without liver problems. This helps researchers understand if liver problems change how the body handles the medicine. You can join if you are an adult between 18 and 80 years old with a Body Mass Index (BMI) between 18.5 and 42 kg/m². The study plans to include 32 participants and is currently unclear about its recruitment status.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 32 participants, including healthy individuals and those with liver problems.
What's involved
Participants will receive a single dose of BI 1291583 as a tablet taken by mouth.
Compensation
Not stated in the trial record.
Follow-up
Researchers will measure the amount of BI 1291583 in your blood for up to 29 days after you take the medicine.

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NCT07023354

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

Recruiting
PHASE1Ages 18–80InterventionalTreatment
Boehringer Ingelheim
~32 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:BI 1291583

At a glance

Recruiting sites
2 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 672 h (AUC0-672h)
Measured over Up to Day 29
+1 more outcome measured
Healthy
Hepatic Impairment
4 sites across 3 states
Texas2
California1
Florida1

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Eligibility criteria

Inclusion

Use of combined (oestrogen and progestogen containing) hormonal contraception that prevents ovulation (oral, intravaginal or transdermal), plus condom
Use of progestogen-only hormonal contraception that inhibits ovulation (only injectables or implants), plus condom
Use of intrauterine device (IUD) or intrauterine hormone-releasing system (IUS) plus use of condom
Sexually abstinent
A vasectomised sexual partner who received medical assessment of the surgical success (documented absence of sperm) and provided that partner is the sole sexual partner of the trial participant
Surgically sterilised (including hysterectomy) plus use of condom
Postmenopausal, defined as no menses for 1 year without an alternative medical cause (in questionable cases a blood sample with levels of Follicle Stimulating Hormone (FSH) above 25 U/L and oestradiol below 30 ng/L is confirmatory)
  • Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 672 h (AUC0-672h)Up to Day 29
  • Maximum measured concentration of the analyte in plasma (Cmax)Up to Day 29