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A Study To Assess Effects Of PF-04958242 On Bold Functional Magnetic Resonance Imaging During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects

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ClinicalTrials.gov Identifier: NCT01365338
Recruitment Status : Completed
First Posted : June 3, 2011
Last Update Posted : December 24, 2012
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Pfizer

Brief Summary:
This study aims to determine whether the drug affects brain activity in healthy volunteers, either when the participants are performing a memory task, or when lying at rest. Subjects will undergo a brain scan under both of these conditions after a dose of either the study drug or a placebo is administered.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Placebo Drug: PF-04958242 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 112 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Subject And Investigator-Blinded, Sponsor-Open, Randomized, Single-Dose, Placebo-Controlled, Parallel Group Study To Assess Effects Of PF-04958242 On Bold Functional MRI During Working Memory Activation And Arterial Spin Labeling At Rest In Healthy Subjects
Study Start Date : June 2011
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
oral solution, single dose
Experimental: PF-04958242 - 0.075mg Drug: PF-04958242
oral solution, single dose; 0.075mg
Experimental: PF-04958242 - 0.15mg Drug: PF-04958242
oral solution, single dose; 0.15mg



Primary Outcome Measures :
  1. functional magnetic resonance imaging data during working memory task [ Time Frame: 40 minutes post-dose ]
  2. Arterial spin labeling data [ Time Frame: 50 minutes post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male and/or female subjects of non-childbearing potential between the ages of 21 and 55 years, inclusive
  • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs)

Exclusion Criteria:

  • History of seizures or of a condition with risk of seizures; head injury; any history of DSM-IV Axis I psychiatric disorders; contraindications for MRI

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01365338


Locations
United States, Connecticut
Pfizer Investigational Site
New Haven, Connecticut, United States, 06511
Pfizer Investigational Site
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Pfizer
Yale University
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01365338     History of Changes
Other Study ID Numbers: B1701003
First Posted: June 3, 2011    Key Record Dates
Last Update Posted: December 24, 2012
Last Verified: December 2012

Keywords provided by Pfizer:
schizophrenia fMRI cognition working memory ASL

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders