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

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PF-04958242
Ketamine
Placebo
Ketamine
Sponsored by
Biogen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Schizophrenia focused on measuring PF-04958242, ketamine, cognition, healthy volunteers

Eligibility Criteria

21 Years - 45 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PF-04958242

Placebo

Arm Description

PF-04958242 and ketamine

Placebo and ketamine

Outcomes

Primary Outcome Measures

Test score on the Hopkins Verbal Learning Test - Immediate Recall

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2012
Last Updated
November 19, 2019
Sponsor
Biogen
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1. Study Identification

Unique Protocol Identification Number
NCT01749098
Brief Title
A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers
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 Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biogen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
PF-04958242, ketamine, cognition, healthy volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PF-04958242
Arm Type
Experimental
Arm Description
PF-04958242 and ketamine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo and ketamine
Intervention Type
Drug
Intervention Name(s)
PF-04958242
Intervention Description
PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo capsule orally administered on Days 1 - 5
Intervention Type
Drug
Intervention Name(s)
Ketamine
Intervention Description
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 Measure Information:
Title
Test score on the Hopkins Verbal Learning Test - Immediate Recall
Time Frame
Day 5
Secondary Outcome Measure Information:
Title
Test score on the Weschler Digit Span Test
Time Frame
Day 5
Title
Test score on the CogState N-back test
Time Frame
Day 5
Title
Test score on the CogState Spatial Working memory test
Time Frame
Day 5
Title
Test score on the CogState One Card Learning test
Time Frame
Day 5
Title
Test score on the Hopkins Verbal Learning test - Delayed Recall
Time Frame
Day 5
Title
Retrospective rating on the Positive and Negative Syndrome Scale -modified scale'
Time Frame
Day 5

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Biogen
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
Pfizer Investigational Site
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1701013&StudyName=A%20Study%20To%20Examine%20The%20Effects%20Of%20PF-04958242%20On%20Ketamine-Induced%20Cognitive%20Impairment%20In%20Healthy%20Volunteers
Description
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A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers

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