Table 2.
Summary of key alisertib pharmacokinetic parameters in the fed and fasted states
| Parameter | Alisertib 50 mg | Geometric mean ratio, fed versus fasted (90 % CI) | |
|---|---|---|---|
| Fed state (n = 14) | Fasted state (n = 14) | ||
| Median t max, h (range) | 6.0 (1.9–9.0) | 3.0 (2.0–6.0) | – |
| Mean t ½, h (SD) | 14.9 (4.8) | 16.7 (4.4)a | – |
| Geometric mean C max, nM (CV %) | 1299.9 (36) | 1583.8 (53) | 0.84 (0.66–1.06) |
| Geometric mean AUCtlast, nM*h (CV %) | 21,673.93 (49) | 21,183.04 (60) | 1.04 (0.80–1.34) |
| Geometric mean AUCinf, nM*h (CV %) | 24,934.1 (55) | 26,190.8 (69)a | 0.94 (0.68–1.32) |
AUC tlast/AUC inf area under the concentration–time curve from time zero to last determined concentration-time point/infinity, C max maximum plasma concentration, CI confidence interval, CV coefficient of variation, SD standard deviation, t ½ terminal half-life, t max time to C max
a n = 11