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A single 125 mg oral dose of the investigational compound PD-0332991 will be administered alone and after steady-state dosing of tamoxifen to determine if coadministration of tamoxifen alters the plasma pharmacokinetics of PD-0332991 in healthy male volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PD-0332991 alone | Drug | PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)] of PD-0332991 | 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). | 0-144 hrs post PD-0332991 dose |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PD-0332991 | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) | 0-144 hrs post PD-0332991 dose |
| Maximum Observed Plasma Concentration (Cmax) of PD-0332991 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | New Haven | Connecticut | 06511 | United States |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Tamoxifen 60 mg | Drug | On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets). |
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| Tamoxifen 20 mg | Drug | On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses. |
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| 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. |
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| 0-144 hrs post PD-0332991 dose |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) of PD-0332991 | 0-144 hrs post PD-0332991 dose |
| Plasma Decay Half-Life (t1/2) of PD-0332991 | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. | 0-144 hrs post PD-0332991 dose |
| Apparent Oral Clearance (CL/F) of PD-0332991 | Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood. | 0-144 hrs post PD-0332991 dose |
| Apparent Volume of Distribution (Vz/F) of PD-0332991 | Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed. | 0-144 hrs post PD-0332991 dose |
| Minimum Observed Plasma Trough Concentration (Cmin) of tamoxifen | Days 1, 5, 12, 21, 22, and 28 of Period 2 |
| Minimum Observed Plasma Trough Concentration (Cmin) of 4-hydroxytamoxifen | Days 1, 5, 12, 21, 22, and 28 of Period 2 |
| Minimum Observed Plasma Trough Concentration (Cmin) of N-desmethyltamoxifen | Days 1, 5, 12, 21, 22, and 28 of Period 2 |
| Minimum Observed Plasma Trough Concentration (Cmin) of endoxifen | Days 1, 5, 12, 21, 22, and 28 of Period 2 |
| ID | Term |
|---|---|
| C500026 | palbociclib |
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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