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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01244880
• Other study ID #: A8241014
• Status: Terminated
• Phase: Phase 1
• First received: November 5, 2010
• Last updated: March 19, 2014
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: March 2014
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

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:
• Saline
Saline infusion for 56 minutes
• Placebo
Placebo tablet single dose
• Ketamine
Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
• Placebo
Placebo tablet single dose

Locations

Country	Name	City	State
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut
United States	Pfizer Investigational Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Lateral prefrontal cortex activation during causal learning and working memory tasks as measured by arterial spin labelling imaging		Day 1 of each treatment period	No
Secondary	Causal learning task prediction error score for stimulus/outcome associations across 3 stages of learning and expectancy violation		Day 1 of each treatment period	No
Secondary	N-back working memory task number correct		Day 1 of each treatment period	No
Secondary	Positive and Negative Syndrome Scale (PANSS) positive and negative subscale total score		Day 1 of each treatment period	No
Secondary	Clinician administered dissociative states scale (CADSS) total score		Day 1 of each treatment period	No

External Links

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