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

Last updated on May 9, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06510 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Female subjects who are pregnant or breastfeeding.

- Any evidence of significant psychosis-like symptoms.

- Known sensitivity to ketamine.

NCT01244880
Pfizer
Terminated
Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects

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Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects
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
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.
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.
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Healthy
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
August 2012
August 2012   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01244880
A8241014
No
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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