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An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers

Last updated on February 17, 2019

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Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511-5473 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Generalized Anxiety Disorder
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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Subjects must meet all of the following inclusion criteria to be eligible for enrollment
into the trial:

1. Healthy male subjects between the ages of 18 and 55 years, inclusive. (Healthy is
defined as no clinically relevant abnormalities identified by a detailed medical
history, full physical examination, including blood pressure and pulse rate
measurement, 12-lead ECG and clinical laboratory tests).

2. Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg
(110 lbs).

3. Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the trial.

4. Subjects who are willing and able to comply with scheduled confinement period,
treatment plan, laboratory tests, and other trial procedures.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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Subjects presenting with any of the following will not be included in the trial:

1. Evidence or history of clinically significant hematological, renal, endocrine,
pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic,
orallergic disease (including drug allergies, but excluding untreated, asymptomatic,
seasonal allergies at time of dosing).

2. Subjects enrolled in a previous radionucleotide study or who have received
radiotherapy within 12 months prior to screening or such that total radioactivity
would exceed acceptable dosimetry.

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

NCT00537615
Pfizer
Completed
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers

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[email protected]

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