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

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PD 0332334
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site

Outcomes

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

Full Information

First Posted
September 28, 2007
Last Updated
February 16, 2010
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00537615
Brief Title
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
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 Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
PD 0332334
Other Intervention Name(s)
imagabalin
Primary Outcome Measure Information:
Title
Radioactivity parameters in plasma and whole blood - Cmax , Tmax , AUCinf, AUClast, t1/2, CL/F and V/F.
Title
Total 14C data in blood, urine and feces
Title
Ratio of radioactivity in red blood cells to plasma (RBC/plasma)
Title
Cumulative recovery of radioactivity in urine and feces
Title
Identification of metabolites in feces, plasma and urine if possible
Title
Plasma, urine and fecal PD 0332334 pharmacokinetic parameters - Cmax, Tmax, AUClast, AUCinf, t1/2, CL/F, V/F, CLR, Ae24 and Ae24(%)
Secondary Outcome Measure Information:
Title
Pharmacokinetic analysis of metabolites if detectable

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511-5473
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A5361010&StudyName=An%20open-label%20study%20to%20investigate%20the%20absorption%2C%20metabolism%20and%20excretion%20of%20radiolabeled%20PD%200332334%20in%20six%20healthy%20male%20volunteers
Description
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An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers

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