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

Conditions

• Healthy
• Hepatic Impairment

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Accepted

Interventions

• BI 1291583 — DRUG
  BI 1291583

Study Details

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.

Key Dates

Start date

Jul 17, 2025

Status verified

Jun 2026

Primary completion

Sep 17, 2026

Completion

Sep 17, 2026

Study Design

Enrollment

32 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Group 1: Participants with mild liver impairment
  Child-Pugh classification A; score of 5 - 6 points. The Child-Pugh score assesses chronic liver disease severity, factoring in three lab parameters (total bilirubin, serum albumin, and prothrombin time), ascites, and hepatic encephalopathy. Scores are categorized as follows: 5-6 (Class A, mild), 7-9 (Class B, moderate), and 10-15 (Class C, severe), with higher scores indicating more severe disease.
• Experimental: Group 2: Participants with moderate liver impairment
  Child-Pugh classification B; score of 7 - 9 points. The Child-Pugh score assesses chronic liver disease severity, factoring in three lab parameters (total bilirubin, serum albumin, and prothrombin time), ascites, and hepatic encephalopathy. Scores are categorized as follows: 5-6 (Class A, mild), 7-9 (Class B, moderate), and 10-15 (Class C, severe), with higher scores indicating more severe disease.
• Experimental: Group 3: Participants with severe liver impairment
  Child-Pugh classification C; score of 10-15 points. The Child-Pugh score assesses chronic liver disease severity, factoring in three lab parameters (total bilirubin, serum albumin, and prothrombin time), ascites, and hepatic encephalopathy. Scores are categorized as follows: 5-6 (Class A, mild), 7-9 (Class B, moderate), and 10-15 (Class C, severe), with higher scores indicating more severe disease.
• Experimental: Group 4: Healthy trial participants with normal liver function
  Matched to 8 demographic clusters generated from the 24 trial participants of Groups 1 through 3.

Primary Outcome Measure

Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 672 h (AUC0-672h) [ Time Frame: Up to Day 29 ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (3)

Find similar trials in Orlando, FL

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