To investigate the safety, tolerability, pharmacokinetics (including dose proportionality assessment), and pharmacodynamics of single rising oral doses of BI 1181181 (Single rising dose (SRD) part) Secondly, to investigate the relative bioavailability of the tablet versus the powder for oral solution (PfOS) and the effect of food on the pharmacokinetics of BI 1181181 (Bioavailability/Food effect (BA/FE) part)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
65
single dose (low to high dose)
powder for oral solution
tablet, fasted
Placebo to BI 1181181
tablet, fed
1344.1.1 Boehringer Ingelheim Investigational Site
Ingelheim, Germany
Number (%) of subjects with drug-related adverse events (AEs)
Time frame: up to 72 h
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)
Time frame: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
Aet1-t2 (Amount of analyte that is eliminated in urine from the time point t1 to timepoint t2 after single dose administration)
Time frame: up to 72 h
Cmax (maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
tmax (time from dosing to maximum measured concentration of the analyte in plasma)
Time frame: up to 72 h
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 72 h
t1/2 (terminal half-life of the analyte in plasma)
Time frame: up to 72 h
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