TABLE 3

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

Parameter (unit)BI 1015550 6 mg twice daily#BI 1015550 12 mg twice daily#
gMeangCV (%)gMeangCV (%)
Cmax (nmol·L−1)10328.222929.9
AUCτ,1 (nmol·h·L−1)56424.8137015.9
Cmax,ss (nmol·L−1)16421.334814.1
AUCτ,ss (nmol·h·L−1)105025.7230015.8
RA,Cmax1.6035.01.5223.6
RA,AUC1.859.911.6814.8

gMean: geometric mean; gCV: geometric coefficient of variation; Cmax­: maximum measured concentration of analyte in plasma; AUCτ,1: area under the concentration–time curve for the analyte in plasma over a uniform dosing interval τ after the first dose; Cmax,ss: maximum measured concentration of analyte in plasma at steady state over a uniform dosing interval τ; AUCτ,ss: area under the concentration–time curve of the analyte in plasma at steady state over a uniform dosing interval τ; RA,Cmax: accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ, expressed as a ratio of Cmax at steady state and after a single dose; RA,AUC: accumulation ratio of the analyte in plasma after multiple dose administration over a uniform dosing interval τ, expressed as a ratio of AUC at steady state and after a single dose. #: fed, n=8.