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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2007-10-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Interventions

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PD 0332334

Intervention Type DRUG

Other Intervention Names

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imagabalin

Eligibility Criteria

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Inclusion Criteria

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes