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

This study is currently recruiting participants.

Verified May 2013 by Pfizer

Sponsor:

Information provided by (Responsible Party):

Pfizer

ClinicalTrials.gov Identifier:

NCT01749098

First received: December 11, 2012

Last updated: May 20, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 11, 2012

Last Updated Date

May 20, 2013

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

December 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Test score on the Hopkins Verbal Learning Test - Immediate Recall [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01749098 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Test score on the Weschler Digit Span Test [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Test score on the CogState N-back test [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Test score on the CogState Spatial Working memory test [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Test score on the CogState One Card Learning test [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Test score on the Hopkins Verbal Learning test - Delayed Recall [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Retrospective rating on the Positive and Negative Syndrome Scale -modified scale` [ Time Frame: Day 5 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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 Arm (s)

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Estimated Primary Completion Date

December 2013 (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.

Gender

Male

Ages

21 Years to 45 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Pfizer CT.gov Call Center

1-800-718-1021

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01749098

Other Study ID Numbers ^ICMJE

B1701013

Has Data Monitoring Committee

Yes

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

May 2013

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

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