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# | ||
| gMean | gCV (%) | gMean | gCV (%) | |
| Cmax (nmol·L−1) | 710 | 20.7 | 955 | 15.5 |
| AUC0−∞ (nmol·h·L−1) | 5910 | 21.2 | 8700¶ | 17.2 |
| fe0–120 (%) | 12.5¶ | 45.2 | 12.1+ | 13.4 |
| CLR,0–120 (mL·min−1) | 30.5+ | 21.5 | 25.2+ | 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 0–120 h after first drug administration; CLR,0–120: renal clearance of the analyte in plasma over the time interval 0–120 h after first drug administration. #: fasted, n=6; ¶: n=5; +: n=4.