CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 29 enrolled
Drug / intervention
Iclepertindrug
Likely dose
Iclepertin 10 milligramfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05731895
NCT05731895Phase 1Completed

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)

Boehringer Ingelheim·interventional·Posted Feb 16, 2023·Updated Apr 24, 2026

In Brief

A Phase 1 clinical trial evaluating Iclepertin for Hepatic Insufficiency. Completed, enrolled 29 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
202420252026
First PostedFeb 16, 2023
Enrollment StartMar 8, 2023
Primary CompletionDec 11, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.4 years ago

Interventions

Iclepertindrug

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