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CompletedNCT00537615Updated Feb 17, 2010

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

A Phase 1 interventional study of PD 0332334 in Generalized Anxiety Disorder, sponsored by Pfizer. Completed at 1 site in United States. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2010-02-17.

Sponsored by Pfizer · Phase 1, Interventional, and Diagnostic

Phase
Phase 1
Study type
Interventional
Enrollment
6
Allocation
Non-randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Generalized Anxiety Disorder
03

In context

Generalized Anxiety Disorder

146 studies on the registry are indexed under Generalized Anxiety Disorder; 86 are open to participants now.

This study's enrollment of 6 is below the median of 100 across 120 interventional studies indexed under Generalized Anxiety Disorder.

Browse Generalized Anxiety Disorder studies →

Lead sponsor

Pfizer is the lead sponsor of 3,323 studies on the registry; 145 are open to participants now.

Of its 597 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
6 participants (actual)

Interventions

06

What researchers measure

Primary outcomes

  1. Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F.

  2. Total 14C data in blood, urine and feces

  3. Ratio of radioactivity in red blood cells to plasma (RBC/plasma)

  4. Cumulative recovery of radioactivity in urine and feces

  5. Identification of metabolites in feces, plasma and urine if possible

  6. Plasma, urine and fecal PD 0332334 pharmacokinetic parameters - Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F, V/F, CLR, Ae24 and Ae24(%)

Secondary outcomes

  1. Pharmacokinetic analysis of metabolites if detectable

07

Study locations

1 site
  • Pfizer Investigational Site
    New Haven, Connecticut 06511-5473, United States
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References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00537615
Lead sponsor
Pfizer
First posted
Oct 1, 2007
Start date
Sep 2007
Completion
Oct 2007
Last update
Feb 17, 2010

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2010. You cannot join it, but the record below documents what was studied.

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