TABLE 2.
Plasma PK of EDP-420 following a single oral dose
| Parameter (n = 6) | Mean of CV% | EDP-420 dose
|
||||
|---|---|---|---|---|---|---|
| 100 mg | 200 mg | 400 mg | 800 mg | 1,200 mg | ||
| AUC0-∞ (ng·h/ml) | Mean | 3,432 | 7,713 | 14,400 | 33,890 | 38,280 |
| CV% | 10.6 | 25.5 | 28.9 | 35 | 27.1 | |
| AUC0-last (ng·h/ml) | Mean | 3,400 | 7,654 | 14,270 | 33,370 | 37,400 |
| CV% | 10.7 | 25.5 | 27.8 | 33.4 | 26.7 | |
| Cmax (ng/ml) | Mean | 196 | 360 | 542 | 1,066 | 1,076 |
| CV% | 14.8 | 26.4 | 22.9 | 28.4 | 20.7 | |
| Tmax (h) | Median | 1.75 | 2.50 | 3.25 | 4.26 | 5.00 |
| Range | 1.50-5.00 | 1.50-3.50 | 1.50-5.00 | 2.00-6.00 | 3.50-6.00 | |
| t1/2 (h) | Mean | 15.6 | 15.8 | 15.8 | 17.6 | 20.1 |
| CV% | 18.2 | 17.1 | 18.5 | 26.9 | 12.8 | |
| λz (h−1) | Mean | 0.0444 | 0.0440 | 0.0438 | 0.0393 | 0.0344 |
| CV% | 17.9 | 16.2 | 17.4 | 21.9 | 14.1 | |
| CLpo (liters/h) | Mean | 29.1 | 25.9 | 27.8 | 23.6 | 31.4 |
| CV% | 10.6 | 31.5 | 23.6 | 39.3 | 29.5 | |
| Vz/F (liters) | Mean | 656 | 589 | 635 | 601 | 909 |
| CV% | 24.0 | 18.4 | 24.2 | 30.6 | 23.1 | |