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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

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: PF-04958242 Drug: Ketamine Drug: Placebo Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official 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
Study Start Date : December 2012
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: PF-04958242
PF-04958242 and ketamine
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.

Placebo Comparator: Placebo
Placebo and ketamine
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.




Primary Outcome Measures :
  1. Test score on the Hopkins Verbal Learning Test - Immediate Recall [ Time Frame: Day 5 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01749098


Locations
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United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
Biogen
Investigators
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Study Director: Medical Director Biogen

Additional Information:
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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT01749098    
Other Study ID Numbers: B1701013
First Posted: December 13, 2012    Key Record Dates
Last Update Posted: November 21, 2019
Last Verified: November 2019
Keywords provided by Biogen:
PF-04958242
ketamine
cognition
healthy volunteers
Additional relevant MeSH terms:
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Schizophrenia
Cognitive Dysfunction
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Cognition Disorders
Neurocognitive Disorders
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action