Clinical trial NCT01244880: Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Healthy
Keywords: PF-02545920
ketamine
fMRI
associative Learning
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2010-11-19
Enrollment: 4
Sex: ALL
Minimum age (years): 21
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks
timeFrame: Day 1 of each treatment period
Secondary outcomes:
measure: Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging
timeFrame: Day 1 of each treatment period
measure: Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation
timeFrame: Day 1 of each treatment period
measure: N-back working memory task number correct
timeFrame: Day 1 of each treatment period
measure: Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score
timeFrame: Day 1 of each treatment period
measure: Clinician administered dissociative states scale (CADSS) total score
timeFrame: Day 1 of each treatment period
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
city: New Haven
country: United States
facility: Pfizer Investigational Site
state: Connecticut
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References: