CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 36 enrolled
Drug / intervention
BI 425809drug
Likely dose
Not stated in 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/NCT05718843
NCT05718843Phase 1Completed

Pharmacokinetics, Safety and Tolerability of BI 425809 (Iclepertin) Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe, Moderate and Mild) Compared With Matched Male and Female Participants With Normal Renal Function (an Open-label, Non-randomised, Single-dose, Parallel, Individual-matched Design Trial)

Boehringer Ingelheim·interventional·Posted Feb 8, 2023·Updated Mar 30, 2026

In Brief

A Phase 1 clinical trial evaluating BI 425809 for Renal Insufficiency. Completed, enrolled 36 participants across 1 site.

Detailed Summary

This study is open to people with and without kidney problems. People can join the study if they are 18 years or older and have a body mass index (BMI) between 18.5 and 35 kg/m2. Iclepertin is a medicine that is being developed to treat diseases of the brain. The purpose of this study is to find out whether having kidney 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 this time, they visit the study site 6 times. For one of the visits, participants stay 4 nights at the study site. 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
2023202420252026
First PostedFeb 8, 2023
Enrollment StartFeb 1, 2023
Primary CompletionOct 24, 2023
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 3.4 years ago

Interventions

BI 425809drug

Iclepertin orally as film-coated tablet.