Table 1.
Blood collection plan
Sample (Blood) |
Volume (mL) | Cycle | Day | Sample No. | Scheduled time relative to BEZ235 dosing post-dose (hours) |
---|---|---|---|---|---|
3 | 1 | 1 | 1 | Pre-dose | |
2 | 1 h post-dose | ||||
3 | 1 | 1 | 3 | 2 h post-dose | |
3 | 1 | 1 | 4 | 3 h post-dose | |
5 | 5 h post dose | ||||
3 | 1 | 1 | 6 | 8–12 h post-dose | |
(optional) | 3 | 1 | 2 | 7 | 24 h post-dose (trough) |
3 | 1 | 15 | 8 | Pre-dose | |
3 | 1 | 15 | 9 | 1 h post-dose | |
3 | 1 | 15 | 10 | 3 h post-dose | |
3 | 1 | 15 | 11 | 5 h post-dose | |
(optional) | 3 | 1 | 15 | 12 | 8–12 h post-dose |
Blood sample collection plan in the BEZ 235 phase I trial for PK and PD analysis is shown