Effects Of PF-02545920 On Ketamine-Induced Abnormal Prefrontal Brain Response To Associative Learning In Healthy Subjects
This study has been completed.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01244880
First received: November 5, 2010
Last updated: November 27, 2012
Last verified: November 2012
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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 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
|
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
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, 06510 | |
| Pfizer Investigational Site | |
| New Haven, Connecticut, United States, 06520 | |
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: | November 27, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pfizer:
|
PF-02545920 ketamine fMRI associative Learning |
Additional relevant MeSH terms:
|
Ketamine Anesthetics, Dissociative Anesthetics, Intravenous Anesthetics, General Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents |
Therapeutic Uses Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Analgesics Sensory System Agents Peripheral Nervous System Agents |
ClinicalTrials.gov processed this record on May 19, 2013