Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01365338
First received: May 11, 2011
Last updated: December 21, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Schizophrenia
Drug: Placebo
Drug: PF-04958242
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • functional magnetic resonance imaging data during working memory task [ Time Frame: 40 minutes post-dose ] [ Designated as safety issue: No ]
  • Arterial spin labeling data [ Time Frame: 50 minutes post-dose ] [ Designated as safety issue: No ]

Enrollment: 112
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   20 Years to 55 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01365338     History of Changes
Other Study ID Numbers: B1701003
Study First Received: May 11, 2011
Last Updated: December 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
schizophrenia fMRI cognition working memory ASL

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 19, 2014