Table 2.
Parameter | Dose of ACE910 (mg/kg) | ||||||
---|---|---|---|---|---|---|---|
Japanese | White | ||||||
0.01 | 0.1 | 0.3 | 1 | 0.1 | 0.3 | 1 | |
N | 6 | 6 | 6 | 6 | 6 | 6 | 6 |
Cmax (μg/mL) | 0.0675 ± 0.0120 | 0.655 ± 0.0837 | 1.72 ± 0.377 | 5.92 ± 1.24 | 0.603 ± 0.0825 | 2.12 ± 0.244 | 5.56 ± 0.812 |
Tmax (d) | 14.1 (5.00-28.0) |
12.0 (7.00-14.1) |
10.1 (7.00-11.1) |
10.1 (4.00-14.2) |
12.6 (7.00-21.2) |
7.00 (3.00-14.2) |
8.53 (7.00-15.2) |
AUCinf (d × μg/mL) | NC | 30.2 ± 9.28 | 86.5 ± 17.9 | 266 ± 50.0 | 34.6 ± 12.6 | 112 ± 18.2 | 304 ± 79.3 |
t1/2 (d) | NC | 28.3 ± 4.77 | 30.3 ± 4.12 | 29.0 ± 3.26 | 28.8 ± 10.4 | 34.4 ± 6.55 | 32.2 ± 6.68 |
MRT (d) | NC | 44.5 ± 6.26 | 47.3 ± 8.25 | 43.1 ± 4.57 | 47.9 ± 14.6 | 50.8 ± 9.26 | 49.3 ± 9.96 |
CL/F (mL/d/kg) | NC | 3.51 ± 0.776 | 3.61 ± 0.845 | 3.91 ± 0.840 | 3.16 ± 0.933 | 2.75 ± 0.470 | 3.49 ± 0.931 |
Vd/F (mL/kg) | NC | 140 ± 24.1 | 156 ± 28.8 | 163 ± 35.6 | 121 ± 34.8 | 133 ± 14.9 | 156 ± 20.3 |
Data are presented as mean ± standard deviation for Cmax, AUCinf, t1/2, MRT, CL/F, Vd/F, or median (range) for Tmax. Summary statistics were not calculated when a PK parameter was not calculable in the majority of subjects at a certain dose group.
NC, not calculated (N = 2).