Table 4.
Vorinostat (mg) |
Alisertib (mg) |
Cmax (ng/mL) |
Tmax (h) |
AUC0-tau (μg/mL•h) |
Cl/F (L/h) |
t½ (h) |
N |
---|---|---|---|---|---|---|---|
Schedule I | |||||||
200 | 30 | 504 | 1.00 | 1.40 | 143 | 1.73 | 1 |
200 | 40 | 335 (148) | 0.98 (0.04) | 0.956 (0.503) | 243 (128) | 2.31 (1.19) | 2 |
200 | All | 391 (143) | 0.98 (0.03) | 1.10 (0.44) | 210 (107) | 2.12 (0.91) | 3 |
400 | 30 | 806 (582) | 2.58 (1.86) | 2.94 (1.43) | 163 (70) | 2.61 (0.99) | 6 |
All | All | 2.05 (1.67) | 180 (82) | 2.43 (0.93) | 9 | ||
Schedule II | |||||||
200 | 20 | 318 (216) | 2.25 (1.58) | 1.03 (0.54) | 369 (504) | 2.16 (1.29) | 18 |
200 | 30 | 324 (132) | 2.49 (1.76) | 1.01 (0.35) | 219 (79) | 2.29 (1.06) | 6 |
200 | All | 319 (196) | 2.31 (1.59) | 1.03 (0.49) | 331 (440) | 2.19 (1.21) | 24 |
Both Schedules | |||||||
All | 20 | 318 (216) | 2.25 (1.58) | 1.03 (0.54) | 369 (504) | 2.16 (1.29) | 18 |
All | 30 | 560 (455) | 2.42 (1.71) | 1.85 (1.32) | 189 (75) | 2.38 (0.97) | 13 |
All | 40 | 335 (148) | 0.98 (0.04) | 0.956 (0.503) | 243 (128) | 2.31 (1.19) | 2 |
All | All | 2.24 (1.59) | 293 (387) | 2.25 (1.14) | 33 |
Mean (standard deviation).
Median extrapolated portion of AUC0-tau was 0.51 % (range 0-45%).