Table 3. Summary Pharmacokinetic Parameters on D-7 by Dose Level of AZD3965.
Dose Level (mg) | Number of Patients | Cmax (ng/mL) | AUC0-24 (ng/mL•h) | Half-Life (h) | Cl/F (L/h) | Vz/F (L) |
---|---|---|---|---|---|---|
5 | 3 | 21.7–65.6 | 212±85 | 51.9±4.9 | 14.9±3.7 | 1115±290 |
10 | 5 | 28.2–182.2 | 731±311 | 45.4±6.4 | 9.5±1.9 | 630±174 |
20 | 13 | 117.6–431.2 | 1521±497 | 36.5±5.7 | 11.4±3.8 | 595±206 |
30 | 11 | 191.2–808.0 | 3466±1952 | 38.1±10.4 | 9.5±5.2 | 534±363 |
Dose level of 20 mg includes data from AZD3965 20 mg OD and 10 mg BD dose cohorts (both received 20 mg on D-7) and dose level of 30 mg includes data from AZD3965 30 mg OD and 15 mg BD dose cohorts (both received 30 mg on D-7). All values expressed as mean ± standard deviation, except for Cmax, where range is presented.
Abbreviations: AUC0-24, area under the curve during 24 hours; Cmax, maximum observed plasma concentration; Cl/F, apparent clearance of distribution; D=day; Vz/F, apparent volume of distribution.