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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01103726
First Posted: April 15, 2010
Last Update Posted: November 16, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Yale University
Information provided by (Responsible Party):
Pfizer
  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
Intervention Model: Crossover Assignment
Masking: Triple (Participant, 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

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. ]

Secondary Outcome Measures:
  • Whole brain glucose metabolic rate. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ]
  • Relative glucose metabolic rate in striatum. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ]
  • Glucose metabolic rate in striatal subregions: putamen and caudate nucleus. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ]
  • Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus. [ Time Frame: Stage 1: Day 1, 8. Stage 2: Day 1, 8, 15. ]
  • 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. ]
  • 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. ]
  • 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. ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01103726


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
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:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01103726     History of Changes
Other Study ID Numbers: A8241013
First Submitted: April 13, 2010
First Posted: April 15, 2010
Last Update Posted: November 16, 2011
Last Verified: November 2011

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