To investigate safety, tolerability, and pharmacokinetics of BI 425809 following single rising doses of BI 425809 in healthy male volunteers; To explore dose proportionality of BI 425809 as oral drinking solution; To investigate relative bioavailability of BI 425809 oral drinking solution fasted compared to BI 425809 tablet fasted and tablet fed
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
83
1346.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
frequency [N(%)] of subjects with drug related adverse events (AEs)
Time frame: up to 18 days
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 192 hours
AUC0-infinity (area under the concentration-time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to 192 hours
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BI 425809 tablet
BI 425809 PfOS