A Study in People With Normal Kidney Function and People With Reduced Kidney Function to Test How BI 764198 is Processed in the Body

Phase 1

Completed

• Conditions: Healthy; Chronic Kidney Disease
• Interventions: Drug: BI 764198

• Registration Number: NCT04176536
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The main objective of this trial is to investigate the influence of moderate and severe renal impairment on the pharmacokinetics of a single dose of BI 764198 in comparison to a group of matched controls with normal renal function.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-11-22
• Study First Posted: 2019-11-25
• Study Start: 2019-12-10
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-17
• Last Update Posted: 2020-12-19

Recruitment & Eligibility

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

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
All participants	BI 764198	-

Primary Outcome Measures

Name	Time	Method
Cmax (maximum measured concentration of the analyte in plasma)	Up to 96 hours
AUC0-∞ (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)	Up to 96 hours

Secondary Outcome Measures

Name	Time	Method
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 the last quantifiable data point)	Up to 96 hours

Trial Locations

Locations (1)

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