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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Tablet
Tablet
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, United States
The percentage of subjects with drug-related Adverse Events (AEs) among different dose regimes over each up-titration
Time frame: Up to day 28
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)
Time frame: Baseline and Up to 72 hours
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: Up to 72 hours
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]
Time frame: Up to 72 hours
Cmax,ss (maximum measured concentration of the analyte in plasma at steady)
Time frame: Up to 72 hours
Change from baseline in seated systolic blood pressure (SBP)
Time frame: Baseline and Up to 28 days
Change from baseline in seated diastolic blood pressure (DBP)
Time frame: Baseline and Up to 28 days
Change from baseline in heart rate (HR)
Time frame: Baseline and Up to 28 days
Change from baseline in body weight
Time frame: Baseline and Up to 28 days
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