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

Last updated on May 12, 2018

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Schizophrenia
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
21-45 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT01749098
Pfizer
Completed
A Study To Examine The Effects Of PF-04958242 On Ketamine-Induced Cognitive Impairment In Healthy Volunteers

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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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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.
Sexes Eligible for Study: Male
21 Years to 45 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01749098
B1701013
Yes
Not Provided
Not Provided
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

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



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