Safety, tolerability, pharmacokinetics and early pharmacodynamics of single rising oral doses of BI 1021958 tablets in healthy male volunteers (first-in-human trial)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
66
tablet
drinking solution / tablet
SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast
1310.1.1 Boehringer Ingelheim Investigational Site
Biberach, Germany
Number of participants with clinically relevant findings in physical examination
Time frame: up to 14 days postdose
Number of participants with clinically relevant findings in vital signs
Time frame: up to 14 days postdose
Number of participants with clinically significant abnormalities in electrocardiogram (ECG) results
Time frame: up to 14 days postdose
Number of participants with significant changes from baseline laboratory measurements
Time frame: up to 14 days postdose
Number of participants with adverse events
Time frame: up to 14 days postdose
Assessment of tolerability by investigator
Time frame: up to 14 days postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)
Time frame: up to 72h postdose
area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity (AUC0-inf)
Time frame: up to 72h postdose
AUC0-tz (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 up to the last quantifiable data point)
Time frame: up to 72h postdose
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