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Trial record 1 of 1 for:    NCT01103726
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Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01103726
Recruitment Status : Completed
First Posted : April 15, 2010
Last Update Posted : November 16, 2011
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE April 13, 2010
First Posted Date  ICMJE April 15, 2010
Last Update Posted Date November 16, 2011
Study Start Date  ICMJE May 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2011)
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. ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
Glucose metabolic rates in striatum using standard Region of Interest (ROI) analysis method. [ Time Frame: Weeks 1,2/3 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2011)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2010)
  • Whole brain glucose metabolic rate. [ Time Frame: Weeks 1,2/3 ]
  • Relative glucose metabolic rate in striatum. [ Time Frame: Weeks 1,2/3 ]
  • Glucose metabolic rate in striatal subregions: putamen and caudate nucleus. [ Time Frame: Weeks 1,2/3 ]
  • Relative glucose metabolic rate in striatal subregions: putamen and caudate nucleus. [ Time Frame: Weeks 1,2/3 ]
  • Glucose metabolic rate in striatum determined using data-driven ROI analysis method. [ Time Frame: Weeks 1,2/3 ]
  • Relative glucose metabolic rate in striatum determined using data-driven ROI analysis method. [ Time Frame: Weeks 1,2/3 ]
  • 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: Weeks 1,2/3 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation Of Striatal Glucose Metabolism With Positron Emission Tomography Following PF-02545920 In Healthy Subjects
Official Title  ICMJE 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
Brief Summary We hypothesize that PF-02545920 will increase glucose metabolism in a part of the brain called the striatum.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: PF-02545920
    1 and 5 mg tablets, 6 mg single dose
  • Drug: placebo
    matching placebo tablets, single dose
  • 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
Study Arms  ICMJE
  • Experimental: Stage 1
    Interventions:
    • Drug: PF-02545920
    • Drug: placebo
  • Experimental: Stage 2
    Interventions:
    • Drug: PF-02545920
    • Drug: PF-02545920
    • Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2011)
34
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2010)
31
Actual Study Completion Date  ICMJE November 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01103726
Other Study ID Numbers  ICMJE A8241013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Yale University
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP