Table 2.
Ponatinib pharmacokinetic parameters in plasma under fasted and fed (high-fat and low-fat) conditionsa
| Tmax, hb | Cmax, ng/mL (%CV) | AUC0-t, h × ng/mL (%CV) | AUC0-∞, h × ng/mL (%CV) | T1/2, hc (%CV) | CL/F, L/h (%CV) | V/F, L (%CV) | |
|---|---|---|---|---|---|---|---|
| Fasted (n = 22) | 6·0 (5·0–8·0) | 54·7 (26·1) | 1203 (26·9) | 1273 (28·3) | 24·2 (14·7) | 35·4 (35·0) | 1242 (30·0) |
| High-fat meal (n = 22) | 6·0 (4·0–12·0) | 51·5 (26·3) | 1315 (27·5) | 1392 (29·1) | 23·5 (16·1) | 32·3 (34·2) | 1104 (28·8) |
| Low-fat meal (n = 22) | 5·0 (5·0–8·0) | 51·6 (27·2) | 1175 (28·7) | 1244 (29·7) | 23·3 (14·9) | 36·2 (38·7) | 1278 (37·6) |
Tmax, time to maximum concentration; Cmax, maximum plasma concentration; %CV, coefficient of variation; AUC0-t, area under the concentration–time curve from time zero to the last measurable time point; AUC0-∞, area under the concentration–time curve from zero to infinity; T1/2, terminal elimination half-life; CL/F, clearance after oral administration; V/F, volume in the terminal elimination phase.
a
Geometric mean values with %CV are shown.
b
Value for Tmax is median (range).
c
Value for T1/2 is median.