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

Study Overview
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Brief Summary
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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.

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

Official Title
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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

Conditions
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Healthy Volunteer

Intervention / Treatment
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* Drug: Placebo
* Drug: PF-04958242


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |