A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Liver Problems
- Registration Number
- NCT05661344
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
This study is open to adults aged 18 years and older. People without liver problems and people who have mild or moderate liver problems can join the study.
The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without liver problems. Liver problems may change how a medicine is processed in the body.
Participants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants' blood. Then they compare the results between the groups of participants with and without liver problems. The doctors also check participants' health and take note of any unwanted effects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 4: participants with normal hepatic function individually matched to participants of Group 2 BI 1015550 One participant with normal hepatic function may match one participant in one or both groups of participants with hepatic impairment. The matching criteria of the participants with normal hepatic function to the participants with hepatic impairment: Age (± 10 years) Gender Weight (± 15%) Group 1: participants with mild hepatic impairment (Child-Pugh A) BI 1015550 - Group 3: participants with normal hepatic function individually matched to participants of Group 1 BI 1015550 One participant with normal hepatic function may match one participant in one or both groups of participants with hepatic impairment. The matching criteria of the participants with normal hepatic function to the participants with hepatic impairment: Age (± 10 years) Gender Weight (± 15%) Group 2: participants with moderate hepatic impairment (Child-Pugh B) BI 1015550 -
- Primary Outcome Measures
Name Time Method Maximum measured concentration of the analyte in plasma (Cmax) up to 7 days 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) up to 7 days
- 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-∞) up to 7 days
Trial Locations
- Locations (1)
CRS Clinical Research Services Kiel GmbH
🇩🇪Kiel, Germany