Table 4.
Pharmacokinetic Parameters Obtained from Plasma Samples of Patients Receiving Daily Oral Dose of Palbociclib on Day 15 of Cycle 2.
Tmax (h) | Ctrough (ng/mL) | Cmax (ng/mL) | Dose-normalized Cmax (ng/mL) | AUC0-24h (h ng/mL) | Dose-normalized AUC0-24h (h ng/mL) | |
---|---|---|---|---|---|---|
100 mg daily dose cohort (n=2) | ||||||
Subject 002 | 8 | 49.4 | 70 | 70 | 1,476 | 1,476 |
Subject 003 | 8 | 65.2 | 101 | 101 | 2,012 | 2,012 |
Summary | 8 | 56.8 | 84 | 84 | 1,723 | 1,723 |
125 mg daily dose cohort (n=4) | ||||||
Subject 004 | 4 | 83.2 | 141 | 113 | 2,679 | 2,142 |
Subject 005 | 4 | 76.8 | 144 | 115 | 2,724 | 2,179 |
Subject 006 | 8 | 52.1 | 145 | 116 | 2,231 | 1,785 |
Subject 009 | 4 | 55.6 | 107 | 86 | 1,792 | 1,434 |
Summary | 4 (4-8) | 66 (23) | 133 (14) | 106 (14) | 2,324 (19) | 1,859 (19) |
Data are median (range) for Tmax and geometric mean (coefficient of variation%, CV%) for Cmax, AUC0-24h and dose-normalized AUC0-24h