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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01103726

Enrollment

Registered

2010-04-15

Start date

2010-05-31

Completion date

2011-11-30

Last updated

2011-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

Keywords

FDG-PET, regional cerebral glucose metabolism, striatum, PDE10 inhibitor

Brief summary

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

Interventions

DRUGPF-02545920

1 and 5 mg tablets, 6 mg single dose

DRUGplacebo

matching placebo tablets, single dose

DRUGPlacebo

matching placebo tablets, single dose

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	Time frame
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.
Whole brain glucose metabolic rate.	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.
Glucose metabolic rate in striatum determined using data-driven ROI analysis method.	Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026