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

Completed · Phase 1

Conditions studied: Generalized Anxiety Disorder

In brief

The purpose of this study is to investigate the absorption, metabolism and excretion of \[14C\] PD 0332334 to characterize plasma, fecal and urinary radioactivity and identify any metabolites of \[14C\] PD 0332334.

Key facts

Study ID

NCT00537615

Run by

Pfizer

People needed

6

Starts

2007-09-01

Expected to finish

2007-10-01

Last updated by the study team

2010-02-17

Who can join

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

You may qualify if…

• Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
• 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).
• Body Mass Index (BMI) of approximately 18 to 30 kg/m2; and a total body weight >50 kg (110 lbs).
• 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.
• Subjects who are willing and able to comply with scheduled confinement period, treatment plan, laboratory tests, and other trial procedures.

You may not qualify if…

• Subjects presenting with any of the following will not be included in the trial:
• 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).
• 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.
• Subjects whose occupation requires exposure to radiation or monitoring of radiation exposure.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.