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

This study has been terminated.
(See termination reason in detailed description.)
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01244880
First received: November 5, 2010
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Healthy
Other: Saline
Drug: PF-02545920
Other: Ketamine
Other: Placebo
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Lateral prefrontal cortex activation as measured by functional MRI (fMRI) BOLD imaging during causal learning and working memory tasks [ Time Frame: Day 1 of each treatment period ] [ Designated as safety issue: No ]

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

Enrollment: 4
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Saline/PF-02545920
Treatments are co-administered
Other: Saline
Saline infusion for 56 minutes
Drug: PF-02545920
PF-02545920 10 mg single dose
Experimental: Ketamine/PF-02545920
Treatments are co-administered
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
Placebo Comparator: Saline/Placebo
Treatments are co-administered
Other: Saline
Saline infusion for 56 minutes
Other: Placebo
Placebo tablet single dose
Experimental: Ketamine/Placebo
Treatments are co-administered
Other: Ketamine
Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
Other: Placebo
Placebo tablet single dose

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

Ages Eligible for Study:   21 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01244880

Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Pfizer Investigational Site
New Haven, Connecticut, United States, 06520
Pfizer Investigational Site
New Haven, Connecticut, United States, 06510
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01244880     History of Changes
Other Study ID Numbers: A8241014
Study First Received: November 5, 2010
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
PF-02545920
ketamine
fMRI
associative Learning

Additional relevant MeSH terms:
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014