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

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01103726
First received: April 13, 2010
Last updated: November 11, 2011
Last verified: November 2011
  Purpose

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


Condition Intervention Phase
Healthy
Drug: PF-02545920
Drug: placebo
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Whole brain glucose metabolic rate. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]
  • Relative glucose metabolic rate in striatum. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]
  • Glucose metabolic rate in striatal subregions: putamen and caudate nucleus. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]
  • Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]
  • Glucose metabolic rate in striatum determined using data-driven ROI analysis method. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]
  • Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]
  • Effect size comparison between standard ROI and data-driven ROI analysis methods using both regional glucose metabolic rate and relative regional glucose metabolic rate. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ] [ Designated as safety issue: No ]

Enrollment: 34
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stage 1 Drug: PF-02545920
1 and 5 mg tablets, 6 mg single dose
Drug: placebo
matching placebo tablets, single dose
Experimental: Stage 2 Drug: PF-02545920
1 mg tablets, 3 mg single dose
Drug: PF-02545920
5 mg tablets, 15 mg single dose
Drug: Placebo
matching placebo tablets, single dose

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01103726

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Pfizer
Yale University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01103726     History of Changes
Other Study ID Numbers: A8241013
Study First Received: April 13, 2010
Last Updated: November 11, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
FDG-PET
regional cerebral glucose metabolism
striatum
PDE10 inhibitor

ClinicalTrials.gov processed this record on April 17, 2014