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Completed

NCT Number: NCT01103726

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, New Haven, Connecticut, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PF-02545920

Drug

1 and 5 mg tablets, 6 mg single dose

Placebo

Drug

matching placebo tablets, single dose

Primary outcomes

  1. 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.

Secondary outcomes

  1. Whole brain glucose metabolic rate.

    Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

  2. Relative glucose metabolic rate in striatum.

    Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

  3. Glucose metabolic rate in striatal subregions: putamen and caudate nucleus.

    Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

  4. Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus.

    Time frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Pfizer

Industry

Collaborators

  • Yale University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 15, 2010
Registry last updated
Nov 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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