Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
palbociclib commercial free base · 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 |
|---|---|---|
| Cohort 1: Palbociclib under fed conditions | EXPERIMENTAL | - |
| Cohort 2: Palbociclib under fed conditions | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| palbociclib commercial free base | DRUG | 125 mg oral capsule single dose |
| famotidine | DRUG | 20 mg oral tablet 10 hours before and 2 hours after palbociclib |
| rabeprazole | DRUG | 2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib |
| antacid | DRUG | 30 mL orally once (2h before palbociclib) |
Inclusion Criteria: * Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive. * Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight \>50 kg (110 lbs). * Willing and able to comply with all scheduled visits, treatment plan, l...
Palbociclib commercial free base is an investigational small molecule being studied in healthy volunteers. It is being evaluated in a Phase 1 clinical trial to assess the effects of three different stomach acid reducing agents when given with palbociclib and food. The study is not intended to treat a disease.
Palbociclib commercial free base is being developed by Pfizer, Inc., a company traded on the New York Stock Exchange under the ticker symbol PFE. The company is conducting clinical research on this small molecule drug candidate.
Palbociclib commercial free base is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The single clinical trial for this drug has been completed.
Palbociclib commercial free base has one completed clinical trial, identified as NCT02097329. This Phase 1 study, titled "Study Of Three Different Stomach Acid Reducing Agents When Given With Palbociclib (PD-0332991) And Food," enrolled 27 healthy volunteers in the United States.
Yes, palbociclib commercial free base is also known as PD-0332991. The clinical trial NCT02097329 references this alternative name in its title, indicating that both names refer to the same drug substance being studied by Pfizer.