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

NCT ID: NCT01103726

Last Updated: 2011-11-16

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Stage 1

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

1 and 5 mg tablets, 6 mg single dose

placebo

Intervention Type DRUG

matching placebo tablets, single dose

Stage 2

Group Type EXPERIMENTAL

PF-02545920

Intervention Type DRUG

1 mg tablets, 3 mg single dose

PF-02545920

Intervention Type DRUG

5 mg tablets, 15 mg single dose

Placebo

Intervention Type DRUG

matching placebo tablets, single dose

Interventions

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PF-02545920

1 and 5 mg tablets, 6 mg single dose

Intervention Type DRUG

placebo

matching placebo tablets, single dose

Intervention Type DRUG

PF-02545920

1 mg tablets, 3 mg single dose

Intervention Type DRUG

PF-02545920

5 mg tablets, 15 mg single dose

Intervention Type DRUG

Placebo

matching placebo tablets, single dose

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Pfizer Investigational Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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A8241013

Identifier Type: -

Identifier Source: org_study_id