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# | ||
| gMean | gCV (%) | gMean | gCV (%) | |
| Cmax (nmol·L−1) | 103 | 28.2 | 229 | 29.9 |
| AUCτ,1 (nmol·h·L−1) | 564 | 24.8 | 1370 | 15.9 |
| Cmax,ss (nmol·L−1) | 164 | 21.3 | 348 | 14.1 |
| AUCτ,ss (nmol·h·L−1) | 1050 | 25.7 | 2300 | 15.8 |
| RA,Cmax | 1.60 | 35.0 | 1.52 | 23.6 |
| RA,AUC | 1.85 | 9.91 | 1.68 | 14.8 |
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.