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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01749098
Recruitment Status : Completed
First Posted : December 13, 2012
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE December 11, 2012
First Posted Date  ICMJE December 13, 2012
Last Update Posted Date November 21, 2019
Study Start Date  ICMJE December 2012
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
Test score on the Hopkins Verbal Learning Test - Immediate Recall [ Time Frame: Day 5 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2012)
  • Test score on the Weschler Digit Span Test [ Time Frame: Day 5 ]
  • Test score on the CogState N-back test [ Time Frame: Day 5 ]
  • Test score on the CogState Spatial Working memory test [ Time Frame: Day 5 ]
  • Test score on the CogState One Card Learning test [ Time Frame: Day 5 ]
  • Test score on the Hopkins Verbal Learning test - Delayed Recall [ Time Frame: Day 5 ]
  • Retrospective rating on the Positive and Negative Syndrome Scale -modified scale` [ Time Frame: Day 5 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers
Official Title  ICMJE 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
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.
Detailed Description This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Schizophrenia
Intervention  ICMJE
  • Drug: PF-04958242
    PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5
  • Drug: Ketamine
    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.
  • Drug: Placebo
    Placebo capsule orally administered on Days 1 - 5
  • Drug: Ketamine
    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.
Study Arms  ICMJE
  • Experimental: PF-04958242
    PF-04958242 and ketamine
    Interventions:
    • Drug: PF-04958242
    • Drug: Ketamine
  • Placebo Comparator: Placebo
    Placebo and ketamine
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2014)
29
Original Estimated Enrollment  ICMJE
 (submitted: December 11, 2012)
38
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01749098
Other Study ID Numbers  ICMJE B1701013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP