Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects
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
1 other identifier
interventional
34
1 country
3
Brief Summary
We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started May 2010
Longer than P75 for phase_1 healthy
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2010
CompletedFirst Posted
Study publicly available on registry
April 15, 2010
CompletedStudy Start
First participant enrolled
May 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedNovember 16, 2011
November 1, 2011
1.5 years
April 13, 2010
November 11, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (7)
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.
- +2 more secondary outcomes
Study Arms (2)
Stage 1
EXPERIMENTALStage 2
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Women of reproductive potential
- History of agranulocytosis or movement disorder
- Positron Emission Tomography (PET) or Magnetic Resonance Imaging (MRI) contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
- Yale Universitycollaborator
Study Sites (3)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Pfizer Investigational Site
New Haven, Connecticut, 06519, United States
Pfizer Investigational Site
New Haven, Connecticut, 06520, United States
Related Links
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2010
First Posted
April 15, 2010
Study Start
May 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
November 16, 2011
Record last verified: 2011-11