Table 5.
Mean steady-state pharmacokinetic parameters for onalespiba.
| Dose | Dose | No. of | Cmax | AUC24 | CL | Vz | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| level | (mg/m2) | Visit | patients | (ng/mL) | (ng h/mL) | (L/h/m2) | (L/m2) | ||||
| 0 | 20 | C1D1 | 3 | 51.2 | (62.9) | 312.8 | (32.8) | 52.3 | (34.3) | 777 | (28.9) |
| 0 | 20 | C1D15 | 2 | 46.7 | (8.2) | 305.8 | (12.3) | 49.7 | (21.6) | 899 | (1.6) |
| 1 | 40 | C1D1 | 4 | 128.2 | (61.3) | 672.8 | (10.9) | 49.4 | (13.4) | 1,290 | (179) |
| 1 | 40 | C1D15 | 3 | 116.8 | (78.4) | 657.5 | (6.8) | 51.1 | (5.4) | 732 | (3.2) |
| 2 | 40 | C1D1 | 4 | 140.6 | (188.5) | 602.4 | (48.9) | 57.0 | (48.2) | 786 | (34.8) |
| 2 | 40 | C1D15 | 3 | 196.7 | (115) | 782.7 | (53.4) | 44.7 | (52.8) | 561 | (53.6) |
| 3 | 80 | C1D1 | 5 | 238.4 | (94.4) | 1207.0 | (17.3) | 58.3 | (14.7) | 718 | (15.4) |
| 3 | 80 | C1D15 | 3 | 278.2 | (64.1) | 1073.2 | (23.6) | 69.2 | (25.2) | 662 | (28.4) |
| 2a | 80 | C1D1 | 3 | 271.6 | (127) | 1461.7 | (59.0) | 47.1 | (57.7) | 624 | (50.2) |
| 2a | 80 | C1D15 | 3 | 267.0 | (175) | 1241.7 | (52.6) | 57.0 | (46.9) | 684 | (57.1) |
| 3a | 120 | C1D1 | 5 | 560.3 | (99.1) | 2082.8 | (34.2) | 49.4 | (33.4) | 614 | (59.4) |
| 3a | 120 | C1D15 | 2 | 390.3 | (38.5) | 2003.1 | (11.6) | 53.7 | (8.0) | 597 | (16.6) |
aData are reported as the geometric mean (geometric %CV).