Actively Recruiting
Open Label, Single Dose, Parallel-group Study to Evaluate the PK and the Safety and Tolerability of Single Oral Doses of BI 1291583 in People With Mild, Moderate and Severe Liver Impairment Compared to Healthy Participants
Led by Boehringer Ingelheim · Updated on 2026-05-28
32
Participants Needed
3
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying how the medicine BI 1291583 is absorbed into the blood in adults aged 18 to 80 years with a body mass index (BMI) between 18.5 and 42 kg/m². This study focuses on people with bronchiectasis, a long-term lung condition, and examines whether having liver problems affects the amount of BI 1291583 in the blood. Participants include those with varying degrees of liver function, as liver issues are common in people with bronchiectasis. Participants receive one oral dose of BI 1291583 and are divided into four groups based on liver health: healthy liver function, and mild, moderate, or severe liver impairment. Each healthy participant is matched with others in the liver impairment groups by age, sex, smoking habits, and weight to allow accurate comparisons. The study is open-label and non-randomized. The study lasts about three months, involving a three-day stay at the study site and up to nine visits. During these visits, doctors collect health information and take regular blood samples to measure BI 1291583 levels and monitor safety. Researchers track the area under the curve (AUC) and maximum concentration (Cmax) of BI 1291583 in plasma to understand how the drug behaves in different liver conditions.
CONDITIONS
Brief Title
A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 80 years at screening
- Body Mass Index (BMI) between 18.5 and 42 kg/m²
- Signed informed consent according to international and local regulations
- For females, use of highly effective contraception from 30 days before dosing until 5 months after dosing
- Participants with liver impairment must have Child-Pugh classification A, B, or C
- Stable medication or treatment regimens for at least 7 days or 5 half-lives before randomization
- Healthy participants must be matched to liver impaired participants by sex, age, smoking habits, and weight
You will not qualify if you...
- Any medical condition posing safety risk or interfering with study objectives, except those related to liver impairment
- Clinically relevant abnormal laboratory values not related to liver disease
- Severe gastrointestinal, kidney, lung, heart, metabolic, immune, or hormonal disorders
- Alpha fetoprotein level greater than 50 ng/mL at screening
- Gastrointestinal surgery that may affect drug absorption, except certain minor surgeries
- Central nervous system diseases, including seizures, stroke, or psychiatric disorders
- History of orthostatic hypotension or fainting spells
- Relevant acute or chronic infections
- Other exclusion criteria as specified by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 29 days
Participants receive a single oral dose of BI 1291583 to evaluate how the drug is processed in the blood.
1 dosing visit and multiple follow-up visits for blood sampling up to Day 29
Trial Site Locations
Total: 3 locations
1
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
Actively Recruiting
2
Tranquil Clinical Research
Houston, Texas, United States, 77598
Completed
3
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States, 78215
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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