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

Purpose

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.

Condition	Intervention	Phase
Anxiety Disorders	Drug: PD 0332334	Phase I

MedlinePlus related topics:

Anxiety

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Pharmacokinetics Study

Official Title:	A Phase 1 Open-Label Single-Radiolabeled Dose Study To Investigate The Absorption, Metabolism And Excretion Of [14C] PD 0332334 In Six Healthy Male Volunteers

Further study details as provided by Pfizer:

Primary Outcome Measures:

Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F.
Total 14C data in blood, urine and feces
Ratio of radioactivity in red blood cells to plasma (RBC/plasma)
Cumulative recovery of radioactivity in urine and feces
Identification of metabolites in feces, plasma and urine if possible
Plasma, urine and fecal PD 0332334 pharmacokinetic parameters - Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F, V/F, CLR, Ae24 and Ae24(%)

Secondary Outcome Measures:

Pharmacokinetic analysis of metabolites if detectable

Estimated Enrollment:	6
Study Start Date:	October 2007
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537615

Locations


United States, Connecticut
	Pfizer Investigational Site
	New Haven, Connecticut, United States, 06511-5473

Sponsors and Collaborators

Pfizer

Investigators


Study Director:	Pfizer CT.gov Call Center	Pfizer

More Information

To obtain contact information for a study center near you, click here. This link exits the ClinicalTrials.gov site

Study ID Numbers:	A5361010
First Received:	September 28, 2007
Last Updated:	January 16, 2008
ClinicalTrials.gov Identifier:	NCT00537615
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anxiety Disorders

Mental Disorders

Healthy

ClinicalTrials.gov processed this record on October 24, 2008

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00537615