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

NCT00537615 | Completed Phase 1

• 1 other identifier: A5361010
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Pharmacokinetic analysis of metabolites if detectable

Interventions

PD 0332334 DRUG

Also known as: imagabalin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (1)

Pfizer Investigational Site

New Haven, Connecticut, 06511-5473, United States

Location

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

imagabalin

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 28, 2007
• First Posted: October 1, 2007
• Study Start: September 1, 2007
• Study Completion: October 1, 2007
• Last Updated: February 17, 2010

Record last verified: 2010-02

Locations

US (1)