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

Last updated: August 7, 2025
Sponsor: Boehringer Ingelheim
Overall Status: Active - Recruiting

Phase

1

Condition

Primary Biliary Cholangitis

Treatment

BI 1291583

Clinical Study ID

NCT07023354
1397-0024
U1111-1312-8762
  • Ages 18-80
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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 Councilon Harmonisation (ICH) Harmonized Guideline for Good Clinical Practice (GCP) andlocal legislation prior to admission to the trial

  4. Female trial participants who meet any of the following criteria for a highlyeffective contraception from at least 30 days before the first administration oftrial medication until 5 months after trial dosing

  • Use of combined (oestrogen and progestogen containing) hormonal contraceptionthat prevents ovulation (oral, intravaginal or transdermal), plus condom

  • Use of progestogen-only hormonal contraception that inhibits ovulation (onlyinjectables 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 surgicalsuccess (documented absence of sperm) and provided that partner is the solesexual partner of the trial participant

  • Surgically sterilised (including hysterectomy) plus use of condom

  • Postmenopausal, defined as no menses for 1 year without an alternative medicalcause (in questionable cases a blood sample with levels of Follicle StimulatingHormone (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 historyincluding a full physical examination, vital signs (blood pressure (BP), pulse rate (PR)), 12-lead electrocardiogram (ECG), and clinical laboratory tests at bothscreening and admission to trial site, with the exception of findings that in theopinion of the investigator are consistent with the participant's hepatic impairment

  3. Medication and/or treatment regimens must have been stable (i. e., no doseadjustments) for at least 7 days or 5 half-lives (whichever is longer) prior to theplanned randomisation and should be kept stable until study completion. Fluctuatingtreatment regimens may be considered for inclusion on a case-by-case basis if theunderlying disease is under control in the opinion of the investigator and must beagreed 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 tosex, age, smoking habit and weight

Exclusion

Exclusion Criteria:

Exclusion criteria applying to all trial participants:

  1. Any medical condition or finding in the medical examination that in theinvestigator's opinion assessed as clinically relevant, poses a safety risk for thetrial participant or may interfere with the study objectives (except for conditionsassociated with hepatic impairment in trial participant with compromised hepaticfunction)

  2. Any laboratory value outside the reference range that the investigator considers tobe of clinical relevance (apart from values due to underlying disease)

  3. Severe gastrointestinal, renal (estimated Glomerular Filtration Rate (eGFR) ChronicKidney Disease Epidemiology (CKD-EPI) <40 ml/min/1.73 m2 for the hepatic impairedtrial participants and Estimated Glomerular Filtration Rate (eGFR) Chronic KidneyDisease Epidemiology (CKD-EPI) <60 ml/min/1.73 m2 for matched controls),respiratory, cardiovascular, metabolic, immunological or hormonal disorders assessedas 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 pharmacokineticsof the trial medication (except cholecystectomy, appendectomy or simple herniarepair)

  6. Diseases of the central nervous system (including but not limited to any kind ofseizures 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

Study Design

Total Participants: 32
Treatment Group(s): 1
Primary Treatment: BI 1291583
Phase: 1
Study Start date:
July 17, 2025
Estimated Completion Date:
March 20, 2026

Connect with a study center

  • Orlando Clinical Research Center

    Orlando, Florida 32809
    United States

    Active - Recruiting

  • Tranquil Clinical Research

    Houston, Texas 77598
    United States

    Site Not Available

  • American Research Corporation at the Texas Liver Institute

    San Antonio, Texas 78215
    United States

    Active - Recruiting

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