Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Palbociclib administered Fasted
Palbociclib administered · 1 trial · 1 indication
AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8). It is obtained from AUC (0 - t) plus AUC (t - 8).
| Arm | Type | Description |
|---|---|---|
| Palbociclib given to healthy volunteers | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Palbociclib administered Fasted | DRUG | palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose |
| Palbociclib administered Fed high calorie | DRUG | palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose |
| Palbociclib administered Fed low calorie | DRUG | palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose |
| Palbociclib administered Fed moderate calorie | DRUG | palbociclib given between moderate calorie meal; capsule form, 125 mg single dose |
Inclusion Criteria: * Healthy male subjects and/or female subjects of non-childbearing potential between the ages of 18 and 55 years * Evidence of a personally signed and dated informed consent document indicating that the subject (or a legal representative) has been informed of all pertinent aspec...