Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
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...
Palbociclib administered refers to an oral small molecule drug developed by Pfizer, Inc. (NYSE: PFE). It is an investigational CDK4 and CDK6 inhibitor. The specific indication for this formulation has not been disclosed. It has been studied in a Phase 1 trial in healthy volunteers to characterize the effect of food on its absorption.
Palbociclib administered targets CDK4, CDK6, and CCND1. It is a small molecule inhibitor that blocks these cyclin-dependent kinases, which are involved in cell cycle regulation. By inhibiting CDK4 and CDK6, it may interfere with cancer cell proliferation. The drug is being developed by Pfizer, Inc. (NYSE: PFE).
Palbociclib administered is developed by Pfizer, Inc., which trades on the New York Stock Exchange under the ticker symbol PFE. Pfizer is a global pharmaceutical company. The drug is an investigational small molecule CDK4 and CDK6 inhibitor.
Palbociclib administered is in Phase 1 clinical development. It is investigational and has not been approved by the FDA for any indication. The Phase 1 trial has been completed. The drug is being developed by Pfizer, Inc. (NYSE: PFE).
Palbociclib administered has been studied in one completed Phase 1 clinical trial, NCT01904747, titled "Characterization Of The Effect Of Food On Palbociclib (PD-0332991) Absorption." The trial enrolled 28 healthy adult volunteers in the United States. It was an uncontrolled, non-randomized study.
Palbociclib administered fasted is an alternative name for palbociclib administered. Both refer to the same investigational drug developed by Pfizer, Inc. (NYSE: PFE). The fasted designation likely relates to the food-effect study, NCT01904747, which examined palbociclib absorption under fasting conditions.