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

Launched by BOEHRINGER INGELHEIM · Jun 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how a new medicine called BI 1291583 behaves in the blood of people with and without liver problems. BI 1291583 is being developed to help treat bronchiectasis, a long-term lung condition, and because many people with this lung condition also have liver issues, the study wants to see if liver problems affect how the medicine is absorbed and processed in the body.

Adults between 18 and 80 years old with a body weight within a certain range may be eligible to join, whether they have healthy livers or varying levels of liver impairment (mild, moderate, or severe). Participants will take a single dose of the medicine as a tablet and will be grouped based on their liver health. The study lasts about three months and involves staying at the study site for a few days, with several follow-up visits where doctors will take blood samples and monitor health to understand how the medicine works and check for any side effects. This information will help ensure the medicine is safe and effective for people with different liver conditions.

Gender

ALL

Eligibility criteria

• Inclusion Criteria :
• • 1. Male or female trial participants aged ≥18 and ≤80 years at screening
• • 2. Body Mass Index (BMI) of 18.5 to 42 kg/m² (inclusive)
• • 3. Signed and dated written informed consent in accordance with International Council on Harmonisation (ICH) Harmonized Guideline for Good Clinical Practice (GCP) and local legislation prior to admission to the trial
• • 4. Female trial participants who meet any of the following criteria for a highly effective contraception from at least 30 days before the first administration of trial medication until 5 months after trial dosing
• • 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)
• In addition to the overall inclusion criteria given, trial participants with impaired hepatic function must fulfil the following criteria:
• • 1. Hepatic impairment classified as Child-Pugh A (score 5-6 points) or Child-Pugh B (score 7-9 points) or Child Pugh C (score 10-15 points)
• • 2. Absence of significant abnormalities, as based on a complete medical history including a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at both screening and admission to trial site, with the exception of findings that in the opinion of the investigator are consistent with the participant's hepatic impairment
• • 3. Medication and/or treatment regimens must have been stable (i. e., no dose adjustments) for at least 7 days or 5 half-lives (whichever is longer) prior to the planned randomisation and should be kept stable until study completion. Fluctuating treatment regimens may be considered for inclusion on a case-by-case basis if the underlying disease is under control in the opinion of the investigator and must be agreed to by both the investigator and the sponsor's medical monitor
• In addition to the overall inclusion criteria given, trial participants with normal hepatic function must fulfill the following criteria:
• • 1. Individually matched to trial participation with hepatic impairment according to sex, age, smoking habit and weight
• Exclusion Criteria:
• Exclusion criteria applying to all trial participants:
• • 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