Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01821066 | A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers | PHASE1 | COMPLETED | 25 | — | — | Apr 1, 2013 | Aug 1, 2013 | Oct 8, 2015 | 1 | United States |
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...