NCT05718843

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Renal Insufficiency

Interventions

Type	Name	Description
DRUG	BI 425809	Iclepertin orally as film-coated tablet.

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-10-24
• Completion: 2023-10-24
• First posted: 2023-02-08
• Last updated: 2026-03-30
• Results posted: 2026-03-30

Locations

1 site across 1 country: Germany