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

Phase 1

Completed

• Conditions: Renal Insufficiency
• Interventions: Drug: BI 425809

• Registration Number: NCT05718843
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-30
• Study First Submitted QC: 2023-01-30
• Study Start: 2023-02-01
• Study First Posted: 2023-02-08
• Primary Completion: 2023-10-24
• Study Completion: 2023-10-24
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-17
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 3: Participants with moderate renal impairment	BI 425809	-
Group 4: Participants with normal renal function matching Group 3	BI 425809	-
Group 1: Participants with severe renal impairment	BI 425809	-
Group 6: Participants with normal renal function matching Group 5	BI 425809	-
Group 5: Participants with mild renal impairment	BI 425809	-
Group 2: Participants with normal renal function individually matched to participants of Group 1	BI 425809	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to 7 days.
Maximum measured concentration of BI 425809 in plasma (Cmax)	Up to 7 days.

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of BI 425809 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)	Up to 7 days.

Trial Locations

Locations (1)

CRS Clinical Research Services Kiel GmbH; 🇩🇪 Kiel, Germany