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RECRUITING
NCT06957756
PHASE1

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

Sponsor: Boehringer Ingelheim

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.

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

Interventions

DRUG

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