A Study To Determine If Coadministration Of Tamoxifen Alters The Extent Or Rate Of Palbociclib (PD-0332991) Absorption Or Elimination In Healthy Male Volunteers

Pfizer

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: PD-0332991 combination; Drug: Tamoxifen 60 mg; Drug: PD-0332991 alone; Drug: Tamoxifen 20 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01821066

A5481026

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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 drug screen
• a supine systolic blood pressure >140 mm Hg, or diastolic blood pressure >90 mm H.
• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Two-Period Fixed-Sequence Arm

Experimental group

Description:

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.

Treatment:

Drug: Tamoxifen 20 mg

Drug: Tamoxifen 60 mg

Drug: PD-0332991 alone

Drug: PD-0332991 combination