A Study to Test How BI 1291583 is Taken up in the Blood of People With and Without Liver Problems
- Registration Number
- NCT07023354
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 32
Not provided
Exclusion criteria applying to all trial participants:
- 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)
- Any laboratory value outside the reference range that the investigator considers to be of clinical relevance (apart from values due to underlying disease)
- 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
- Alpha fetoprotein >50 ng/mL (>50 µg/L) at screening
- Surgery of the gastrointestinal tract that could interfere with the pharmacokinetics of the trial medication (except cholecystectomy, appendectomy or simple hernia repair)
- Diseases of the central nervous system (including but not limited to any kind of seizures or stroke), and other relevant neurological or psychiatric disorders
- History of relevant orthostatic hypotension, fainting spells, or blackouts
- Relevant chronic or acute infections
- Further exclusion criteria apply
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1: Participants with mild liver impairment BI 1291583 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. Group 2: Participants with moderate liver impairment BI 1291583 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. Group 3: Participants with severe liver impairment BI 1291583 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. Group 4: Healthy trial participants with normal liver function BI 1291583 Matched to 8 demographic clusters generated from the 24 trial participants of Groups 1 through 3.
- Primary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to 672 h (AUC0-672h) Up to Day 29 Maximum measured concentration of the analyte in plasma (Cmax) Up to Day 29
- Secondary Outcome Measures
Name Time Method Area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞ of BI 1291583) Up to Day 29 Area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz of BI 1291583) Up to Day 29
Trial Locations
- Locations (3)
Orlando Clinical Research Center
🇺🇸Orlando, Florida, United States
Tranquil Clinical Research
🇺🇸Houston, Texas, United States
American Research Corporation at the Texas Liver Institute
🇺🇸San Antonio, Texas, United States