Table 4. Summary statistics* of Nilotinib pharmacokinetic parameter values at steady-state (Day 8 or 15).
Cohort 1 n=15 |
Cohort 2 n=6 |
Cohort 3 n=6 |
Cohort 4 n=5 |
Cohort 5 n=12 |
|
---|---|---|---|---|---|
Nilotinib dose | 400 mg bid | 200 mg qd | 400 mg qd | 400 mg bid | 400 mg bid |
Imatinib dose | 0 mg | 400 mg bid | 400 mg bid | 400 mg bid | 400 mg qd |
tmax, h | 2.8 (0-9.8) |
4.0 2.9-6.3) |
6.4 (1.9-23.8) |
2.1 (0-12.5) |
0 (0-5.0) |
Cmax, ng/mL | 1644±828 | 655±277 | 1236±705 | 2160±756 | 2509±1266 |
Cavg, ng/mL | 1172±587 | 438±150 | 863±472 | 1617±610 | 1642±701 |
AUC0-t, ng*h/mL | 13636±6617 | 10474±3491 | 20498±11135 | 18717±8516 | 16760±9450 |
CL/F, L/h | 35.6±16.7† | 21.5±9.3† | 25.6±13.8† | 24.8±10.0† | 19.1±6.1‡ |
Median (range) for tmax and mean±SD for other PK parameters.
CL/F was estimated as dose/AUC0-t.
n=3; CL/F was estimated as dose/AUCτ.