A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers
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
1 other identifier
interventional
29
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 schizophrenia
Started Dec 2012
Typical duration for phase_1 schizophrenia
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 11, 2012
CompletedFirst Posted
Study publicly available on registry
December 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2014
CompletedNovember 21, 2019
November 1, 2019
1.2 years
December 11, 2012
November 19, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Test score on the Hopkins Verbal Learning Test - Immediate Recall
Day 5
Secondary Outcomes (6)
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
- +1 more secondary outcomes
Study Arms (2)
PF-04958242
EXPERIMENTALPF-04958242 and ketamine
Placebo
PLACEBO COMPARATORPlacebo and ketamine
Interventions
PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (2)
Pfizer Investigational Site
New Haven, Connecticut, 06511, United States
Pfizer Investigational Site
West Haven, Connecticut, 06516, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2012
First Posted
December 13, 2012
Study Start
December 1, 2012
Primary Completion
February 1, 2014
Study Completion
February 1, 2014
Last Updated
November 21, 2019
Record last verified: 2019-11