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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Saline/PF-02545920

Treatments are co-administered

Group Type EXPERIMENTAL

Saline

Intervention Type OTHER

Saline infusion for 56 minutes

PF-02545920

Intervention Type DRUG

PF-02545920 10 mg single dose

Ketamine/PF-02545920

Treatments are co-administered

Group Type EXPERIMENTAL

Ketamine

Intervention Type OTHER

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

PF-02545920 10 mg tablet

PF-02545920

Intervention Type DRUG

PF-02545920 10 mg tablet single dose

Saline/Placebo

Treatments are co-administered

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type OTHER

Saline infusion for 56 minutes

Placebo

Intervention Type OTHER

Placebo tablet single dose

Ketamine/Placebo

Treatments are co-administered

Group Type EXPERIMENTAL

Ketamine

Intervention Type OTHER

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

Placebo

Intervention Type OTHER

Placebo tablet single dose

Interventions

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Saline

Saline infusion for 56 minutes

Intervention Type OTHER

PF-02545920

PF-02545920 10 mg single dose

Intervention Type DRUG

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

Intervention Type OTHER

PF-02545920

PF-02545920 10 mg tablet single dose

Intervention Type DRUG

Saline

Saline infusion for 56 minutes

Intervention Type OTHER

Placebo

Placebo tablet single dose

Intervention Type OTHER

Ketamine

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

Intervention Type OTHER

Placebo

Placebo tablet single dose

Intervention Type OTHER

Eligibility Criteria

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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.