PK Parameter | Treatment | N | n | Geometric Mean | 95% CI |
---|---|---|---|---|---|
U | µg | ||||
Part A (single dose) | |||||
AUC(0–24) (h*pg/ml) | 50 | 12 | 0 | NE | NE |
100 | 12 | 2 | 596 | (242, 1467) | |
200 | 13 | 5 | 722 | (370, 1408) | |
500 | 12 | 10 | 2460 | (1564, 3871) | |
1000 | 9 | 8 | 3690 | (2756, 4940) | |
2000 | 12 | 11 | 7781 | (5587, 10,838) | |
Cmax (pg/ml) | 50 | 12 | 12 | 36.9 | (30.3, 45.0) |
100 | 12 | 12 | 90.9 | (75.2, 110) | |
200 | 13 | 12 | 171 | (131, 223) | |
500 | 12 | 12 | 356 | (280, 453) | |
1000 | 9 | 9 | 580 | (433, 777) | |
2000 | 12 | 12 | 1325 | (1009, 1741) | |
Part B (repeat dosing) | |||||
AUC(0–24) (h*pg/ml) | 2000 | Day 1 | 8 | 8163 | (4764, 13,989) |
2000 | Day 14 | 9 | 9942 | (6759, 14,622) | |
Cmax (pg/ml) | 2000 | Day 1 | 9 | 1146 | (819, 1603) |
2000 | Day 14 | 9 | 1306 | (958, 1779) |
Cmax, maximum observed plasma concentration; N, total number of subjects; n, total number of subjects with sufficient samples with detectable levels of drug; NE, not evaluable.