How the medicine BI 1291583 gets into the blood of people with and without liver problems.
Official title: 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.
Run by Boehringer Ingelheim · NCT07023354 · Data updated 2026-11-12
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 |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 32 (estimated) |
| Sponsor | Boehringer Ingelheim Industry-sponsored |
| Locations | 4 sites (Rialto, California and 3 other locations) |
| Status | Recruiting |
| Started | July 17, 2025 |
| Main results expected | December 23, 2026 |
| Study ends | December 23, 2026 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT07023354 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Inland Empire Clinical Trials, LLC
Rialto, California, United States Recruiting -
Orlando Clinical Research Center
Orlando, Florida, United States Completed -
Tranquil Clinical Research
Houston, Texas, United States Completed -
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States Completed
Study contacts
- Study coordinator: Boehringer Ingelheim
- Email: clintriage.rdg@boehringer-ingelheim.com
- Phone: 1-800-243-0127
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Casdatifan pharmacokinetics in moderate hepatic impairment vs normal liver function
This study tests how a single dose of casdatifan behaves in people with moderate liver impairment compared to healthy individuals with normal liver function.
-
How the medicine Atirmociclib behaves in people with healthy liver or with liver disease
This study tests how atirmociclib is processed in the body and how safe it is for adults with normal liver function or with stable mild to severe liver disease.
-
Treprostinil Palmitil Inhalation Powder: how liver function affects drug in a single-dose test
This study tests how mild to severe liver impairment changes the amount of treprostinil palmitil and treprostinil in the body after one 80 mcg dose of TPIP in people with and without liver problems.
-
How liver impairment affects AZD9550 and AZD6234
This trial will test how single subcutaneous doses of two investigational drugs, AZD9550 and AZD6234, are processed and tolerated in adults with moderate or severe liver impairment compared with matched healthy volunteers.
-
How BI 3000202 behaves in the blood in people with and without liver problems
This study tests how BI 3000202 moves through the body in healthy adults and adults with liver impairment.
-
Radiprodil for adults with liver impairment
It will test whether a single 15 mg oral dose of radiprodil is processed differently and tolerated safely in adults with mild, moderate, or severe liver impairment compared with healthy adults.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.