Table 4.
Pharmacokinetics of Tenalisib.
| Parameter | 200 mg BID | 400 mg BID | 800 mg BID | 800 mg BID (fed) | ||||
|---|---|---|---|---|---|---|---|---|
| C1D1 | C2D1 | C1D1 | C2D1 | C1D1 | C2D1 | C1D1 | C2D1 | |
| Cmax * (ng/mL) | 1297.3 | 1651.4 | 2196.7 | 2897.7 | 3995.7 | 3231.5 | 2668.0 | 4165.6 |
| AUC0–∞ * (h * ng/mL) | 3538.3 | 4018.0 | 6530.9 | 5603.9 | 17,363.7 | 17,159.4 | 14,538.5 | 14,233.8 |
| AUC(0-τ) * (h * ng/mL) | 3503.0 | 3970.8 | 6415.5 | 5526.8 | 16,424.2 | 16,200.3 | 13,591.2 | 13,555.3 |
| Tmax # (h) | 1.0 | 0.5 | 0.8 | 0.5 | 1.1 | 2.1 | 2.1 | 1.1 |
| t1/2 * (h) | 1.6 | 1.8 | 1.9 | 2.0 | 2.6 | 2.6 | 2.6 | 2.8 |
| λz (h−1) | 0.4 | 0.4 | 0.4 | 0.4 | 0.3 | 0.3 | 0.3 | 0.3 |
Cmax = Maximum plasma concentration; AUC0-∞ = Area under the curve to infinity; AUC(0-τ) = Area under the plasma concentration-time curve from time of administration to the end of the dosing interval; Tmax = Time taken to reach maximum concentration; t1/2 = Elimination half-life. λz = Apparent terminal elimination rate constant; BID = Twice a day; C = Cycle; D = Day. * Geometric mean; # Median.