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

Ketamine

Brief Summary

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.

Intervention / Treatment

  • 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 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.
  • Placebo (DRUG)
    Placebo capsule orally administered on Days 1 - 5

Condition or Disease

  • Schizophrenia

Phase

  • Phase 1

    • Study Design

    Study type: INTERVENTIONAL
    Status: Completed
    Study results: No Results Available
    Age: 21 Years to 45 Years
    Enrollment: 29 (ACTUAL)
    Funded by: Industry
    Allocation: Randomized
    Primary Purpose: Basic Science

    Masking

    DOUBLE:
    • Participant
    • Investigator

    Clinical Trial Dates

    Start date: Dec 01, 2012
    Primary Completion: Feb 01, 2014 ACTUAL
    Completion Date: Feb 01, 2014 ACTUAL
    Study First Posted: Dec 13, 2012 ESTIMATED
    Results First Posted: Aug 31, 2020
    Last Updated: Nov 19, 2019

    Sponsors / Collaborators

    Lead Sponsor: Biogen
    Lead sponsor is responsible party
    Responsible Party: N/A

    Location

    New Haven, Connecticut, USA
    West Haven, Connecticut, USA

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

    Participant Groups

    • PF-04958242 and ketamine

    • Placebo and ketamine

    Eligibility Criteria

    Sex: Male
    Minimum Age: 21
    Maximum Age: 45
    Age Groups: Adult
    Healthy Volunteers: Yes

    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.

    Primary Outcomes
    • Test score on the Hopkins Verbal Learning Test - Immediate Recall Day 5
    Secondary Outcomes
    • 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

    More Details

    NCT Number: NCT01749098
    Other IDs: B1701013
    Study URL: https://clinicaltrials.gov/study/NCT01749098
    Last updated: Sep 29, 2023