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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PF-02545920; Drug: Placebo

• Registration Number: NCT01103726
• Lead Sponsor: Pfizer

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-13
• Study First Submitted QC: 2010-04-14
• Study First Posted: 2010-04-15
• Study Start: 2010-05
• Status Verified: 2011-11
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Last Update Submitted: 2011-11-11
• Last Update Posted: 2011-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Stage 2	Placebo	-
Stage 1	PF-02545920	-
Stage 1	Placebo	-
Stage 2	PF-02545920	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States