Table 5.
Descriptive statistics for V-7404 plasma pharmacokinetic parameters for multiple ascending doses administered twice daily, day 14 (pharmacokinetic assessment set)
| Cohort/dose (mg) | Statisticb | AUC0–tau (ng · h/ml) | Cmax (ng/ml) | Cmax(0–4 h) (ng/ml) | Cmax(4–24 h) (ng/ml) | tmax (h)a | tmax(0–4 h) (h)a | tmax(4–24 h) (h)a | t1/2 (h) | CLss/F (liters/h) | Vz/F (liters) | Cavg (ng/ml) | RAUC | RCmax |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 4/2,000 BID (n = 8) | n | 5 | 5 | 5 | 5 | 5 | 5 | 5 | 4 | 5 | 4 | 5 | 5 | 5 |
| GeoMean | 1883 | 1011 | 827.7 | 896.7 | 4.25 | 0.25 | 0.50 | 2.270 | 2125 | 6542 | 78.55 | 0.9987 | 0.9799 | |
| GeoCV% | 35.4 | 41.0 | 56.5 | 55.8 | 0.25, 4.50 | 0.25, 0.75 | 0.25, 0.52 | 110.6 | 35.3 | 157.6 | 35.6 | 17.2 | 22.8 |
a
Median, minimum, and maximum presented for tmax. tmax, time to Cmax; tmax(0–4 h), tmax during the first dosing interval of the day; tmax(4–24 h), tmax during the second dosing interval of the day.
b
Three participants were withdrawn before day 14 dosing, so n = 5 for the day 14 pharmacokinetic profile.