A Study to Test How Different Doses of BI 685509 Are Tolerated in Patients With Liver Problems

Phase 1

Completed

• Conditions: Healthy; Hepatic Insufficiency
• Interventions: Drug: BI 685509; Drug: Placebo

• Registration Number: NCT03842761
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The primary objective of this trial is the evaluation of safety and tolerability in patients with mild to moderate hepatic impairment \[Child-Turcotte-Pugh (CTP) classification A and B\] over different dose regimes of BI 685509 compared to placebo. A secondary objective is to investigate pharmacokinetics of different doses of BI 685509 in patients with mild to moderate hepatic impairment (CTP A and CTP B). In addition, another secondary objective is to compare safety, tolerability, and pharmacokinetics in patients with mild to moderate hepatic impairment (CTP A and CTP B) of single BI 685509 dose to individually matched healthy volunteers

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-02-13
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-15
• Study Start: 2019-03-06
• Primary Completion: 2021-04-09
• Study Completion: 2021-05-20
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose group 3	BI 685509	High Dose
Dose Group 4	BI 685509	Dose for healthy volunteers dependent on results from prior dose groups with patients
Dose Group 4	Placebo	Dose for healthy volunteers dependent on results from prior dose groups with patients
Dose group 2	Placebo	Medium Dose
Dose group 2	BI 685509	Medium Dose
Dose group 3	Placebo	High Dose
Dose group 1	BI 685509	Low Dose
Dose group 1	Placebo	Low Dose

Primary Outcome Measures

Name	Time	Method
The percentage of subjects with drug-related Adverse Events (AEs) among different dose regimes over each up-titration	Up to day 28

Secondary Outcome Measures

Name	Time	Method
AUCτ,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval τ) [AUCτ,ss will be AUC0-12,ss for bid dosing]	Up to 72 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady)	Up to 72 hours
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to time of the last quantifiable data point)	Baseline and Up to 72 hours
Cmax (maximum measured concentration of the analyte in plasma)	Up to 72 hours
Change from baseline in body weight	Baseline and Up to 28 days
Change from baseline in seated systolic blood pressure (SBP)	Baseline and Up to 28 days
Change from baseline in seated diastolic blood pressure (DBP)	Baseline and Up to 28 days
Change from baseline in heart rate (HR)	Baseline and Up to 28 days

Trial Locations

Locations (1)

American Research Corporation at the Texas Liver Institute; 🇺🇸 San Antonio, Texas, United States