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

Phase 1

Completed

• Conditions: Hepatic Insufficiency
• Interventions: Drug: BI 425809 (iclepertin)

• Registration Number: NCT05731895
• Lead Sponsor: Boehringer Ingelheim

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-02-08
• Study First Submitted QC: 2023-02-08
• Study First Posted: 2023-02-16
• Study Start: 2023-03-08
• Status Verified: 2023-12
• Primary Completion: 2023-12-11
• Study Completion: 2023-12-11
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 3: Participants with normal hepatic function individually matched to participants of Arm 1	BI 425809 (iclepertin)	-
Arm 1: Participants with mild hepatic impairment (Child-Pugh A)	BI 425809 (iclepertin)	-
Arm 2: Participants with moderate hepatic impairment (Child-Pugh B)	BI 425809 (iclepertin)	-
Arm 4: Participants with normal hepatic function individually matched to participants of Arm 2	BI 425809 (iclepertin)	-

Primary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 to the last quantifiable data point (AUC0-tz)	Up to 9 days
Maximum measured concentration of iclepertin in plasma (Cmax)	Up to 9 days

Secondary Outcome Measures

Name	Time	Method
Area under the concentration-time curve of iclepertin in plasma over the time interval from 0 extrapolated to infinity (AUC0-∞)	Up to 9 days

Trial Locations

Locations (1)

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