The aim of the study is to investigate the safety, tolerability, and pharmacokinetics of multiple rising doses of BI 425809 tablets given orally once daily for 12 days to young and elderly healthy male and female volunteers and to compare single dose pharmacokinetics of BI 425809 given in the morning and in the evening.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
96
Tablets
Tablets
1346.2.1 Boehringer Ingelheim Investigational Site
Mannheim, Germany
frequency [N(%)] of subjects with drug related adverse events (AEs)
Time frame: up to 25 days after first drug administration
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the last quantifiable data point) only part II
Time frame: up to 96 hours
Cmax (maximum measured concentration of the analyte in plasma) only part II
Time frame: up to 96 hours
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 hours after first dose
AUCt,ss (area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 216 hours after last dose
Cmax,ss (maximum measured concentration of the analyte in plasma at steady state over a uniform dosing interval t)
Time frame: up to 216 hours after last dose
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) only part II
Time frame: up to 96 hours
AUCt 0-24(area under the concentration-time curve of the analyte in plasma over a uniform dosing interval t after administration of the first dose)
Time frame: up to 72 hours after first dose
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