Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
PD-0332991 alone · 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 |
|---|---|---|
| Two-Period Fixed-Sequence Arm | EXPERIMENTAL | This arm is comprised of two treatment periods in fixed sequence. Period 1 is 7 days long, while Period 2 is 28 days long. In Period 1 the subjects receive a single 125 mg oral dose of PD-0332991 on Day 1. In Period 2 the subjects receive 4 daily 60 mg oral doses of tamoxifen (Days 1-4), followed by 23 daily 20 mg oral doses of tamoxifen (Days 5-27). On Day 22 of Period 2 the subjects receive a second 125 mg oral dose of PD-0332991. |
| Name | Type | Description |
|---|---|---|
| PD-0332991 alone | DRUG | PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1. |
| Tamoxifen 60 mg | DRUG | On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets). |
| Tamoxifen 20 mg | DRUG | On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses. |
| PD-0332991 combination | DRUG | PD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose. |
Inclusion Criteria: * Healthy male between the ages of 18 and 55 years of age inclusive * Body mass index (BMI) between 17.5 and 30.5 kg/m2 * Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, and other study procedures Exclusion Criteria: * a positive urine d...
PD-0332991 is an investigational small molecule developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial in healthy male volunteers in the United States. The trial evaluated coadministration with tamoxifen and its effect on absorption or elimination. PD-0332991 is also known as palbociclib.
PD-0332991 has been studied in healthy male volunteers in a Phase 1 drug interaction trial, not in a patient population with a disclosed disease. No therapeutic indication for PD-0332991 has been publicly disclosed. The completed trial examined whether coadministration of tamoxifen alters the absorption or elimination of PD-0332991.
PD-0332991 is developed by Pfizer, Inc., which trades under the ticker PFE. Pfizer sponsored the Phase 1 trial of PD-0332991 that evaluated coadministration with tamoxifen in healthy male volunteers. PD-0332991 is also known by the name palbociclib.
PD-0332991 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The completed study enrolled 25 healthy male volunteers in the United States. PD-0332991 is investigational and has not been approved by the FDA for any indication.
PD-0332991 has been evaluated in one completed Phase 1 trial, NCT01821066, titled a study to determine if coadministration of tamoxifen alters the extent or rate of palbociclib (PD-0332991) absorption or elimination in healthy male volunteers. The trial enrolled 25 healthy male participants aged 18 years and older in the United States.
Yes, PD-0332991 is also known as palbociclib. The completed Phase 1 trial NCT01821066 refers to the drug as palbociclib (PD-0332991). Both names refer to the same investigational small molecule developed by Pfizer, Inc. (ticker PFE).