TABLE 2

Phase I study in healthy male subjects: summary of pharmacokinetic parameters of BI 1015550 in the single rising dose part

Parameter (unit)BI 1015550 36 mg#BI 1015550 48 mg#
gMeangCV (%)gMeangCV (%)
Cmax (nmol·L−1)71020.795515.5
AUC0−∞ (nmol·h·L−1)591021.2870017.2
fe0–120 (%)12.545.212.1+13.4
CLR,0–120 (mL·min−1)30.5+21.525.2+20.6

gMean: geometric mean; gCV: geometric coefficient of variation; Cmax­: maximum measured concentration of analyte in plasma; AUC0–: area under the concentration–time curve of the analyte in plasma over the time interval from 0 extrapolated to ∞; fe0–120: fraction of administered drug excreted unchanged in urine over the time interval 0–120h after first drug administration; CLR,0–120: renal clearance of the analyte in plasma over the time interval 0–120h after first drug administration. #: fasted, n=6; : n=5; +: n=4.