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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01749098
First received: December 11, 2012
Last updated: March 7, 2014
Last verified: March 2014

December 11, 2012
March 7, 2014
December 2012
February 2014   (final data collection date for primary outcome measure)
Test score on the Hopkins Verbal Learning Test - Immediate Recall [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01749098 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Schizophrenia
  • 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.
  • Experimental: PF-04958242
    PF-04958242 and ketamine
    Interventions:
    • Drug: PF-04958242
    • Drug: Ketamine
  • Placebo Comparator: Placebo
    Placebo and ketamine
    Interventions:
    • Drug: Placebo
    • Drug: Ketamine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Male
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01749098
B1701013
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
March 2014

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