NCT06272058

A Study to Test How Avenciguat (BI 685509) is Taken up in the Body of People With and Without Liver Problems

Pharmacokinetics, Safety, and Tolerability of BI 685509 in Subjects With Severe Liver Impairment (Child-Pugh Classification C) as Compared to Healthy Subjects

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

This study is open to people with and without severe liver problems. People can join the study if they are 18 to 80 years of age and have a body mass index (BMI) between 18.5 and 42 kg/m2. Avenciguat (BI 685509) is a medicine that is being developed to treat high blood pressure in the portal vein (main vessel going to the liver). The purpose of this study is to find out whether having liver problems influences how Avenciguat (BI 685509) is taken up in the body. All participants take Avenciguat (BI 685509) once as a tablet. Participants are in the study for slightly longer than 1 month. Following the screening period of about 4 weeks, they stay at the study site for 4 nights. Afterwards, there are 2 visits to the study site. The site staff measures the amount of Avenciguat (BI 685509) in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Healthy
• Liver Diseases

Interventions

Type	Name	Description
DRUG	Avenciguat (BI 685509)	Avenciguat (BI 685509)

Timeline

• Start date: 2024-05-03
• Primary completion: 2024-07-02
• Completion: 2024-07-02
• First posted: 2024-02-22
• Last updated: 2025-07-17

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study