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

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

The primary objective of 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.The secondary objective is to evaluate the safety and tolerability of the four doses of PF-04958242 administered orally to healthy adult participants.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteer
• Intervention / Treatment: Drug: PF-04958242; Drug: Placebo

Detailed Description

This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.

• Study Type: Interventional
• Enrollment (Actual): 112
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06519
      • Research Site
    • New Haven, Connecticut, United States, 06511
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Key Inclusion Criteria:

• Body Mass Index (BMI) of 17.5 to 30.5 kilograms per meter squared (kg/m2);
• Total body weight >50 kilograms (kg) (110 pounds [lbs]);

Key Exclusion Criteria:

• Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing);
• Positive urine drug screen;
• Pregnant or nursing females, and females of child bearing potential;
• Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo as a single oral dose.	Drug: Placebo; Administered as specified in the treatment arm
Experimental: Cohort 1; Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose.	Drug: PF-04958242; Administered as specified in the treatment arm
Experimental: Cohort 2; Participants will receive 0.15 mg of PF-04958242 as a single oral dose.	Drug: PF-04958242; Administered as specified in the treatment arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Functional Magnetic Resonance Imaging Data During Working Memory Task	59 Minutes Post-dose
Arterial Spin Labeling Data	39 Minutes Post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Experiencing Adverse Events and Serious Adverse Events	An adverse event is any untoward medical occurrence in a clinical investigation participant administered a product or medical device. A serious adverse event or serious adverse drug reaction is any untoward medical occurrence at any dose that: Results in death; Is life-threatening (immediate risk of death); Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Results in congenital anomaly/birth defect.	Up to Day 11

Collaborators and Investigators

• Sponsor: Biogen
• Collaborators: Yale University

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2011
• Primary Completion (Actual): December 14, 2012
• Study Completion (Actual): December 14, 2012

Study Registration Dates

• First Submitted: May 11, 2011
• First Submitted That Met QC Criteria: June 2, 2011
• First Posted (Estimate): June 3, 2011

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 20, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: B1701003