Table 5. Summary statistics on exposure metrics stratified by dose level.
| Geometric Mean (CV%) | |||||||
|---|---|---|---|---|---|---|---|
| Dose level | (mg/kg) | 0.015 | 0.3 | 1 | 3 | 6 | 10 |
| N | 12 | 3 | 4 | 12 | 3 | 3 | |
| Cmax | (ng/mL) | 297 (50.9) |
5,722 (35.7) |
24,650 (20.4) |
76,126 (25.7) |
152,872 (7.51) | 197,890 (7.02) |
| Cmax/dose | (ng/mL)/µg | 0.251 (52.5) |
0.334 (33.1) |
0.384 (21.6) |
0.345 (25.0) |
0.42(5.78) | 0.290 (8.28) |
| Cmin (28 days) | (ng/mL) | 8.56 (370) |
972 (65.6) |
5615 (9.79) |
13,935 (31.9) |
29,810 (19.4) |
39,455 (36.3) |
| AUC0–28 | (ng·day/mL) | 1519 (70.2) |
49,240 (47.4) | 263,355 (11.8) | 719,907 (20.8) |
1,347,718 (16.7) | 2,006,586 (12.2) |
| AUC0–28 /dose | (ng·day/mL)/µg | 1.28 (78.4) |
2.88 (28.8) |
4.10 (11.6) |
3.26 (20.7) |
3.74 (11.0) |
2.94 18.0) |
N: Number of patients; CV%: coefficient of variation of the geometric mean; Cmax: maximum concentration; Cmin (28 days): trough concentration at day 28; AUC0–28: AUC single dose between 0 and day 28; Dose: actual dose in µg.