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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537615
• Other study ID #: A5361010
• Status: Completed
• Phase: Phase 1
• First received: September 28, 2007
• Last updated: February 16, 2010
• Start date: September 2007
• Est. completion date: October 2007

Study information

• Verified date: February 2010
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: October 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

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:

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• PD 0332334

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

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