Table 3 Summary of BAL27862 PK parameters for cycle 1, day 1 across dose cohorts.
Arm | Tmax (h) | Cmax (ng/mL) | Cmax/dose (ng/mL/mg) | AUClast (h × ng/mL) | T1/2 (h) | AUCinf (h × ng/mL) | CL/F (mL/h) | Vz/F (mL) |
|---|---|---|---|---|---|---|---|---|
15 mg/m2 | ||||||||
N Obs | 1 | 1 | 1 | 1 | 1 | 1 | 1 | 1 |
Mean | 2.5 | 154 | 9.62 | 1810 | 18.1 | 2110 | 7610 | 199,000 |
Geometric mean | 2.5 | 154 | 9.62 | 1810 | 18.1 | 2110 | 7610 | 199,000 |
CV% geometric mean | — | — | — | — | — | — | — | — |
30 mg/m2 | ||||||||
N Obs | 36 | 36 | 36 | 36 | 36 | 36 | 36 | 36 |
Mean | 2.17 | 271 | 7.5 | 2680 | 14.4 | 4150 | 11,500 | 200,000 |
Geometric mean | 2.13 | 267 | 7.3 | 2530 | 12.6 | 3620 | 10,100 | 183,000 |
CV% geometric mean | 16.7 | 19.8 | 24.1 | 35.3 | 57.2 | 55.7 | 58.7 | 41.3 |
45 mg/m2 | ||||||||
N Obs | 8 | 8 | 8 | 8 | 8 | 8 | 8 | 8 |
Mean | 2.39 | 356 | 7.02 | 4340 | 13.6 | 5770 | 12,000 | 190,000 |
Geometric mean | 2.3 | 346 | 6.8 | 3960 | 12.5 | 5090 | 10,000 | 180,000 |
CV% geometric mean | 28.8 | 26.3 | 29.2 | 51.9 | 47.7 | 62.9 | 67 | 33.7 |
60 mg/m2 | ||||||||
N Obs | 21 | 21 | 21 | 21 | 21 | 21 | 21 | 21 |
Mean | 2.41 | 498 | 6.98 | 6040 | 14.3 | 7920 | 10,600 | 206,000 |
Geometric mean | 2.34 | 484 | 6.79 | 5580 | 13.8 | 7180 | 9910 | 197,000 |
CV% geometric mean | 23.8 | 25.1 | 25 | 39.7 | 26.5 | 44.5 | 41 | 32.8 |
80 mg/m2 | ||||||||
N Obs | 7 | 7 | 7 | 7 | 7 | 7 | 7 | 7 |
Mean | 2.35 | 606 | 6.28 | 7760 | 12.9 | 8560 | 12,700 | 227,000 |
Geometric mean | 2.33 | 601 | 6.25 | 7330 | 12.5 | 7950 | 12,100 | 218,000 |
CV% geometric mean | 14.3 | 13.1 | 11 | 36.2 | 26.7 | 40.5 | 35.8 | 31.2 |
