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Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects

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.
 
ClinicalTrials.gov Identifier: NCT01244880
Recruitment Status : Terminated (See termination reason in detailed description.)
First Posted : November 19, 2010
Last Update Posted : March 21, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 5, 2010
First Posted Date  ICMJE November 19, 2010
Last Update Posted Date March 21, 2014
Study Start Date  ICMJE April 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks [ Time Frame: Day 1 of each treatment period ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
  • Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging [ Time Frame: 70-100 min. post study drug dosing ]
  • Causal learning task prediction error score [ Time Frame: 70-85 min. post study drug dosing ]
  • Working memory task score [ Time Frame: 85-100 min. post study drug dosing ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 16, 2012)
  • Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging [ Time Frame: Day 1 of each treatment period ]
  • Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation [ Time Frame: Day 1 of each treatment period ]
  • N-back working memory task number correct [ Time Frame: Day 1 of each treatment period ]
  • Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score [ Time Frame: Day 1 of each treatment period ]
  • Clinician administered dissociative states scale (CADSS) total score [ Time Frame: Day 1 of each treatment period ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2010)
  • Lateral prefrontal cortex activation as measured by arterial spin labelling imaging [ Time Frame: 70-100 min. post study drug dosing ]
  • Positive and Negative Syndrome Scale (PANSS) positive and negative subscale score [ Time Frame: 120 min. post study drug dosing ]
  • Clinician administered dissociative states scale (CADSS) score [ Time Frame: 130 min. post study drug dosing ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects
Official Title  ICMJE Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, 2-Way, 4-Period Crossover Study To Assess Effects Of PF-02545920 On Ketamine-Induced Aberrant Prefrontal Response To Associative Learning In Healthy Subjects
Brief Summary To evaluate whether PF-02545920 reduces the effects of ketamine on brain activation during causal learning as measured by fMRI compared to placebo in healthy human subjects, and to evaluate whether behavioral measures of abnormal causal learning under ketamine are reduced by treatment with PF 02545920.
Detailed Description The study was terminated on November 2, 2012 due to a reassessment of the likelihood of the study meeting its scientific objectives in light of data with the investigational drug obtained from another clinical study. The decision to terminate the trial was not based on any safety concerns.
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
  • Other: Saline
    Saline infusion for 56 minutes
  • Drug: PF-02545920
    PF-02545920 10 mg single dose
  • Other: Ketamine

    Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes

    PF-02545920 10 mg tablet

  • Drug: PF-02545920
    PF-02545920 10 mg tablet single dose
  • Other: Placebo
    Placebo tablet single dose
  • Other: Ketamine
    Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
Study Arms  ICMJE
  • Experimental: Saline/PF-02545920
    Treatments are co-administered
    Interventions:
    • Other: Saline
    • Drug: PF-02545920
  • Experimental: Ketamine/PF-02545920
    Treatments are co-administered
    Interventions:
    • Other: Ketamine
    • Drug: PF-02545920
  • Placebo Comparator: Saline/Placebo
    Treatments are co-administered
    Interventions:
    • Other: Saline
    • Other: Placebo
  • Experimental: Ketamine/Placebo
    Treatments are co-administered
    Interventions:
    • Other: Ketamine
    • Other: 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 Terminated
Actual Enrollment  ICMJE
 (submitted: November 27, 2012)
4
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2010)
20
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Healthy male and/or female subjects between the ages of 21 and 45 years, inclusive. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs). (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
  • Right handed as determined by handedness questionnaire.
  • Able to read and write English as a primary language.

Exclusion Criteria:

  • Female subjects who are pregnant or breastfeeding.
  • Any evidence of significant psychosis-like symptoms.
  • Known sensitivity to ketamine.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 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 NCT01244880
Other Study ID Numbers  ICMJE A8241014
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Pfizer
Original Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Current Study Sponsor  ICMJE Pfizer
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date March 2014

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