NCT07486102

A Study to Test How BI 3000202 is Taken up in the Blood of People With and Without Liver Problems

A Phase I, Open-label, Single-dose Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of BI 3000202 in Adults

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 44 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is open to healthy people and people with liver problems. Adults between 18 and 80 years can participate. The purpose of this study is to compare how a medicine called BI 3000202 is handled by the body in people with and without liver problems. All participants take 1 tablet of BI 3000202. Participants with liver problems may also continue their regular treatment for their liver condition. Participants are in the study for about 1 month. During this time, participants visit the study site about 11 times. Where possible, some of these visits may happen by phone. For some visits, participants stay at the study site overnight. Doctors regularly test the amount of BI 3000202 in the blood and check for any health problems.

Conditions

• Healthy
• Hepatic Impairment

Interventions

Type	Name	Description
DRUG	BI 3000202	BI 3000202

Timeline

• Start date: 2026-04-15
• Primary completion: 2027-02-26
• Completion: 2027-02-27
• First posted: 2026-03-20
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study