Status:

COMPLETED

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

Lead Sponsor:

Pfizer

Conditions:

Healthy

Eligibility:

MALE

18-55 years

Phase:

PHASE1

Brief Summary

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 plas...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

April 1 2013

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 1 2013

Estimated Enrollment :

25 Patients enrolled

Trial Details

Trial ID

NCT01821066

Start Date

April 1 2013

End Date

August 1 2013

Last Update

October 8 2015

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Pfizer Investigational Site

New Haven, Connecticut, United States, 06511