How the medicine BI 1291583 gets into the blood of people with and without liver problems.

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.

This will test how a single oral dose of BI 1291583 enters the bloodstream in adults with and without liver impairment.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Boehringer Ingelheim (Industry-sponsored)
• Locations: 3 sites (Orlando, Florida and 2 other locations)
• Trial ID: NCT07023354 on ClinicalTrials.gov

What this trial studies

Adults aged 18–80 with a BMI of 18.5–42 kg/m², including healthy volunteers and people with mild, moderate, or severe hepatic impairment, are enrolled. Each participant receives a single oral tablet of BI 1291583 and has blood samples taken over time to measure drug concentrations and pharmacokinetics. Participants without liver problems are matched to those with impairment by factors such as age, sex, and smoking status to allow direct comparison. The study compares blood levels across liver-function groups to determine whether liver impairment changes how much drug reaches the bloodstream.

Who should consider this trial

Good fit: Adults aged 18–80 years with BMI 18.5–42 kg/m² who are either healthy or have documented mild, moderate, or severe hepatic impairment and can give informed consent are eligible.

Not a fit: Because this is a single-dose pharmacokinetic study, participants are unlikely to receive direct therapeutic benefit from the medication during the trial.

Why it matters

Potential benefit: If successful, the results could help determine whether dosing changes are needed for people with liver problems who may take BI 1291583 for bronchiectasis.

How similar studies have performed: Comparing drug pharmacokinetics across liver-function groups is a standard and well-established method that has guided dosing for many medications, though BI 1291583 itself is still under development.

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

Where this trial is running

Orlando, Florida and 2 other locations

• Orlando Clinical Research Center — Orlando, Florida, United States (Recruiting)
• Tranquil Clinical Research — Houston, Texas, United States (Completed)
• American Research Corporation at the Texas Liver Institute — San Antonio, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Boehringer Ingelheim

Conditions Healthy; Hepatic Impairment