NCT05731895

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

Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Hepatic Impairment (Child-Pugh Classification A and B) Compared With Matched Male and Female Participants With Normal Hepatic Function (an Open-label, Non-randomised, Single-dose, Parallel, Individualmatched Design Trial)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This study is open to people with and without liver problems. People can join the study if they are 18 to 79 years of age and have a body mass index (BMI) between 18.5 and 35 kg/m2. Iclepertin (also called BI 425809) is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having liver problems influences how iclepertin is taken up in the body. All participants take iclepertin once as a tablet. Participants are in the study for 2 to 3 weeks. During the first part of the study, they stay at the study site for 4 nights. Afterwards, there are 5 visits to the study site and 1 call. The site staff measures the amount of iclepertin in the blood. The doctors also regularly check participants' health and take note of any unwanted effects.

Conditions

• Hepatic Insufficiency

Interventions

Type	Name	Description
DRUG	Iclepertin	A single dose of 10 milligram iclepertin as a film-coated tablet following an overnight fast of at least 10 hours.

Timeline

• Start date: 2023-03-08
• Primary completion: 2023-12-11
• Completion: 2023-12-11
• First posted: 2023-02-16
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

1 site across 1 country: Germany