A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers

Study Overview
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Brief Summary
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To assess if PF-04958242 can attenuate the ketamine-induced cognitive impairment in verbal learning and memory, episodic memory and spatial working memory in healthy volunteers.

Detailed Description
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This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

Official Title
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A Randomized, Subject And Investigator Blinded, Sponsor Open Placebo Controlled, 2 Way, Crossover Phase 1b Study To Examine The Effects Of PF-04958242 On Ketamine Induced Cognitive Impairment In Healthy Male Volunteers

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: PF-04958242
* Drug: Ketamine
* Drug: Placebo
* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male subjects 21 - 45 years old. Able to read and write English as primary language. Subjects who are willing to comply with study procedures. Exclusion Criteria: History of any substance abuse or dependence disorder meeting DSM-IV criteria and/or by SCID-NP within the past 12 months, with the exception of nicotine. Known sensitivity to ketamine Any history of DSM-IV Axis I psychiatric disorders, determined by SCID-NP interview or diagnoses in the view of the investigator.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04958242<br>PF-04958242 and ketamine | Drug: PF-04958242<br>* PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5<br>Drug: Ketamine<br>* At 60 minutes after the 0.25 mg dose of PF-04958242 on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.<br>|
| Placebo Comparator: Placebo<br>Placebo and ketamine | Drug: Placebo<br>* Placebo capsule orally administered on Days 1 - 5<br>Drug: Ketamine<br>* At 60 minutes after Placebo on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test score on the Hopkins Verbal Learning Test - Immediate Recall |  | Day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Test score on the Weschler Digit Span Test |  | Day 5 | 
| Test score on the CogState N-back test |  | Day 5 | 
| Test score on the CogState Spatial Working memory test |  | Day 5 | 
| Test score on the CogState One Card Learning test |  | Day 5 | 
| Test score on the Hopkins Verbal Learning test - Delayed Recall |  | Day 5 | 
| Retrospective rating on the Positive and Negative Syndrome Scale -modified scale' |  | Day 5 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PF-04958242, ketamine, cognition, healthy volunteers