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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00537615
Recruitment Status : Completed
First Posted : October 1, 2007
Last Update Posted : February 17, 2010
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Brief 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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: PD 0332334 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Study Start Date : September 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Intervention Details:
    Drug: PD 0332334
    Other Name: imagabalin

Primary Outcome Measures :
  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 Outcome Measures :
  1. Pharmacokinetic analysis of metabolites if detectable

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00537615

United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511-5473
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer

Additional Information: Identifier: NCT00537615     History of Changes
Other Study ID Numbers: A5361010
First Posted: October 1, 2007    Key Record Dates
Last Update Posted: February 17, 2010
Last Verified: February 2010

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders