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

Completed · Phase 1

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01821066

Run by

Pfizer

People needed

25

Starts

2013-04-01

Expected to finish

2013-08-01

Last updated by the study team

2015-10-08

Who can join

Age: 18 and older, up to 55. Sex: male. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pfizer Investigational Site — New Haven, Connecticut, United States

Full record on ClinicalTrials.gov

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