Clinical trial NCT01103726: Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: FDG-PET
regional cerebral glucose metabolism
striatum
PDE10 inhibitor
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Yale University
First posted: 2010-04-15
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Secondary outcomes:
measure: Whole brain glucose metabolic rate.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
measure: Relative glucose metabolic rate in striatum.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
measure: Glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
measure: Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
measure: Glucose metabolic rate in striatum determined using data-driven ROI analysis method.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
measure: Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
measure: Effect size comparison between standard ROI and data-driven ROI analysis methods using both regional glucose metabolic rate and relative regional glucose metabolic rate.
timeFrame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: