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A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems
Sponsor: Boehringer Ingelheim
Summary
This study is open to adults between 18 and 80 years of age. People with a body mass index (BMI) between 18 and 42 kg/m2 can take part. This study includes people with mild, moderate, and severe liver problems, and people without liver problems as a matching control. The purpose of this study is to find out how mild, moderate, and severe liver problems affect how the body handles a medicine called BI 1584862. Participants take BI 1584862 once. Participants with liver problems are treated in a step-by-step approach with a few days in between for the doctors to review the data and to make sure the participants can tolerate the treatment. Participants may continue their regular treatment for their liver problems during the study. Participants are in the study for about 5 weeks. During this time, they visit the study site 3 times. This also includes an overnight stay for 4 nights. During study visits, the doctors regularly check participants' health and take note of any unwanted effects. To assess the study endpoints, the site staff regularly takes blood samples.
Official title: Pharmacokinetics, Safety and Tolerability of BI 1584862 in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Class A, B, and C) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomized, Single-dose, Parallel, Individual-matched Design Trial)
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2025-08-06
Completion Date
2026-06-29
Last Updated
2026-02-17
Healthy Volunteers
Yes
Conditions
Interventions
BI 1584862
BI 1584862
Locations (3)
Arizona Clinical Trials - Chandler
Chandler, Arizona, United States
Omega Research Orlando, LLC
Orlando, Florida, United States
American Research Corporation
San Antonio, Texas, United States