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 alone is an investigational small molecule being studied in healthy volunteers. In the completed Phase 1 trial, it was used to assess how tamoxifen coadministration affects the absorption or elimination of palbociclib (PD-0332991) in healthy male subjects. The drug is not approved and remains in clinical development.
PD-0332991 alone is being developed by Pfizer, Inc., which trades under the ticker PFE. The company sponsored the Phase 1 clinical trial of this drug in healthy volunteers.
PD-0332991 alone is in Phase 1 clinical development. The single trial for this drug, NCT01821066, is a Phase 1 study that has been completed. The drug is investigational and not yet approved for any use.
PD-0332991 alone is associated with one completed Phase 1 trial, NCT01821066. This study enrolled 25 healthy male volunteers in the United States to evaluate whether coadministration of tamoxifen changes the absorption or elimination of palbociclib (PD-0332991).
Yes, PD-0332991 alone is also known as palbociclib. The clinical trial NCT01821066 refers to the drug as palbociclib (PD-0332991), indicating that PD-0332991 is the investigational code name for palbociclib.