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

Phase 1

Terminated

• Conditions: Healthy
• Interventions: Other: Saline; Other: Ketamine; Drug: PF-02545920; Other: Placebo

• Registration Number: NCT01244880
• Lead Sponsor: Pfizer

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 Timeline

• Study First Submitted: 2010-11-05
• Study First Submitted QC: 2010-11-18
• Study First Posted: 2010-11-19
• Study Start: 2011-04
• Primary Completion: 2012-08
• Study Completion: 2012-08
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-19
• Last Update Posted: 2014-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Saline/PF-02545920	Saline	Treatments are co-administered
Saline/PF-02545920	PF-02545920	Treatments are co-administered
Ketamine/PF-02545920	Ketamine	Treatments are co-administered
Ketamine/PF-02545920	PF-02545920	Treatments are co-administered
Saline/Placebo	Saline	Treatments are co-administered
Saline/Placebo	Placebo	Treatments are co-administered
Ketamine/Placebo	Ketamine	Treatments are co-administered
Ketamine/Placebo	Placebo	Treatments are co-administered

Primary Outcome Measures

Name	Time	Method
Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks	Day 1 of each treatment period

Secondary Outcome Measures

Name	Time	Method
N-back working memory task number correct	Day 1 of each treatment period
Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score	Day 1 of each treatment period
Clinician administered dissociative states scale (CADSS) total score	Day 1 of each treatment period
Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging	Day 1 of each treatment period
Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation	Day 1 of each treatment period

Trial Locations

Locations (1)

Pfizer Investigational Site; 🇺🇸 New Haven, Connecticut, United States