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Completed

NCT Number: NCT01749098

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

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

21 year–45 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Investigational Site, New Haven, Connecticut, United States

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PF-04958242

Drug

PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5

ketamine

Drug

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.

Placebo

Drug

Placebo capsule orally administered on Days 1 - 5

Primary outcomes

  1. Test score on the Hopkins Verbal Learning Test - Immediate Recall

    Time frame: Day 5

Secondary outcomes

  1. Test score on the Weschler Digit Span Test

    Time frame: Day 5

  2. Test score on the CogState N-back test

    Time frame: Day 5

  3. Test score on the CogState Spatial Working memory test

    Time frame: Day 5

  4. Test score on the CogState One Card Learning test

    Time frame: Day 5

  5. Test score on the Hopkins Verbal Learning test - Delayed Recall

    Time frame: Day 5

  6. Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'

    Time frame: Day 5

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 13, 2012
Registry last updated
Nov 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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