Safety,tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BI 1021958 after single rising doses (SRD) in healthy Asian male volunteers
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
matching placebo in each dose level
BI 1021958
matching placebo in each dose level
1310.3.8201 Boehringer Ingelheim Investigational Site
Seoul, South Korea
The number (%) of subjects with related adverse events.
Time frame: up to 17 days postdose
AUC0-inf (area under the concentration-time curve of BI 1021958 in plasma over the time interval from 0 extrapolated to infinity)
Time frame: up to day 4 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 day 4 postdose
AUC0-12 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 12 h)
Time frame: up to day 4 postdose
Cmax (maximum measured concentration of BI 1021958 in plasma)
Time frame: up to day 4 postdose
AUC0-24 (area under the concentration-time curve of BI 1021958 in plasma over the time interval from the time point 0 until the time point 24 h)
Time frame: up to day 4 postdose
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BI 1021958
BI 1021958
BI 1021958
BI 1021958
matching placebo in each dose level
matching placebo in each dose level
matching placebo in each dose level