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A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

Last updated on March 14, 2019

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Study Location
Pfizer Investigational Site
Tacoma, Washington, 98418 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- A Healthy Male Volunteer between 18 and 55 years of age inclusive

- A Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 and a total body weight >50kg

- A signed informed consent document

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular,hepatic,psychiatric, neurologic, or
allergic disease.

- A positive urine drug or urine cotinine screen.

- Concurrent use of herbal or prescription medications or treatment with an
investigational drug within 30 days or 5 half-lives preceding first dose of study
medication.

- Subjects whose occupation requires exposure to radiation or monitoring of radiation
exposure.

- Subjects with a history of irregular bowel movements (eg, regular episodes of diarrhea
or constipation, irritable bowel syndrome (IBS) or lactose intolerance).

NCT01756768
Pfizer
Completed
A Single-Radiolabeled Dose Mass Balance Study To Investigate The Absorption, Metabolism, And Excretion Of [14C] Palbociclib (PD-0332991) In Healthy Male Volunteers

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