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

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.

Timeline

Start

2023-03-08

Primary completion

2023-12-11

Completion

2023-12-11

Publications

• Choi H, Madari S, Daalman E, English BA, Halabi A, Hohl K, Shatillo Y, Weidinger N, Desch M. The Influence of Renal or Hepatic Impairment on the Pharmacokinetics of Iclepertin (BI 425809): Results from Two Phase I Open-Label, Non-randomised, Single Dose, Parallel Design Studies. Drugs R D. 2026 Mar;26(1):83-100. doi: 10.1007/s40268-026-00537-w. Epub 2026 Mar 28.

Drugs

Indications