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

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

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: PF-02545920
* Drug: placebo
* Drug: PF-02545920
* Drug: PF-02545920
* Drug: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole brain glucose metabolic rate. |  | Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. | 
| Relative glucose metabolic rate in striatum. |  | Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. | 
| Glucose metabolic rate in striatal subregions: putamen and caudate nucleus. |  | Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. | 
| Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus. |  | Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. | 
| Glucose metabolic rate in striatum determined using data-driven ROI analysis method. |  | Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. | 
| Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method. |  | 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. |  | Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FDG-PET, regional cerebral glucose metabolism, striatum, PDE10 inhibitor