Clinical Trial

A Study to Test How BI 1584862 is Taken up in the Blood of People With and Without Liver Problems

Completed Phase 1
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 changes
critical Trial completed 2026-05-29
critical Trial status changed: Recruiting → Active, Not Recruiting 2026-05-15
notable Primary completion moved earlier: 2026-06-27 -> 2026-05-11 2026-04-28
minor Completion moved earlier: 2026-06-29 -> 2026-05-11 2026-04-28
Trial Details
NCT Number NCT06957756
Lead Sponsor Boehringer Ingelheim
Conditions Hepatic Insufficiency
Enrollment 43 participants
Start Date 2025-08-06
Primary Completion 2026-05-21 (estimated)
Study Completion 2026-05-21 (estimated)
Updated on ClinicalTrials.gov 2026-07-07