Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects

November 11, 2011 updated by: Pfizer

Evaluation Of Regional Glucose Metabolism In Striatum As Measured By [18f]-Fluorodeoxyglucose Positron Emission Tomography Following Single Oral Dose Administration Of PF-02545920 In Healthy Subjects

We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06519
        • Pfizer Investigational Site
      • New Haven, Connecticut, United States, 06520
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy right-handed male and female subjects between the ages of 18 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)
  • An informed consent document signed and dated by the subject
  • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures

Exclusion Criteria:

  • Women of reproductive potential
  • History of agranulocytosis or movement disorder
  • Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stage 1
Drug: PF-02545920
1 and 5 mg tablets, 6 mg single dose
Drug: placebo
matching placebo tablets, single dose
Drug: PF-02545920
1 mg tablets, 3 mg single dose
Drug: PF-02545920
5 mg tablets, 15 mg single dose
Experimental: Stage 2
Drug: PF-02545920
1 and 5 mg tablets, 6 mg single dose
Drug: PF-02545920
1 mg tablets, 3 mg single dose
Drug: PF-02545920
5 mg tablets, 15 mg single dose
Drug: Placebo
matching placebo tablets, single dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

Secondary Outcome Measures

Outcome Measure
Time Frame
Whole brain glucose metabolic rate.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Glucose metabolic rate in striatum determined using data-driven ROI analysis method.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Effect size comparison between standard ROI and data-driven ROI analysis methods using both regional glucose metabolic rate and relative regional glucose metabolic rate.
Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

April 13, 2010

First Submitted That Met QC Criteria

April 14, 2010

First Posted (Estimate)

April 15, 2010

Study Record Updates

Last Update Posted (Estimate)

November 16, 2011

Last Update Submitted That Met QC Criteria

November 11, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • A8241013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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