NCT05718648

A Study to Test How BI 1015550 is Taken up in the Blood of People With and Without Kidney Problems

Pharmacokinetics, Safety and Tolerability of BI 1015550 Following Oral Administration in Male and Female Participants With Different Degrees of Renal Impairment (Severe and Moderate) as Compared With Individually 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: 26 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

Summary

This study is open to adults aged 18 years and older. People without kidney problems and people who have moderate or severe kidney problems can join the study. The purpose of this study is to find out how a medicine called BI 1015550 is taken up in the blood of people with and without kidney problems. Kidney problems may change how a medicine is taken up in the blood. All participants take a single tablet of BI 1015550. Participants are in the study for about 2 weeks. During this time, they visit the study site 6 times. On the second visit, participants stay overnight at the study site for 4 nights. At the visits, doctors take blood samples to measure the levels of BI 1015550 in participants' blood. Then they compare the results between the groups of participants with and without kidney problems. The doctors also check participants' health and take note of any unwanted effects.

Conditions

• Renal Insufficiency
• Healthy

Interventions

Type	Name	Description
DRUG	BI 1015550	BI 1015550

Timeline

• Start date: 2023-02-09
• Primary completion: 2023-08-15
• Completion: 2023-08-15
• First posted: 2023-02-08
• Last updated: 2025-11-28
• Results posted: 2025-11-28

Locations

1 site across 1 country: Germany