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
Overview
- Phase
- Phase 1
- Intervention
- Placebo
- Conditions
- Healthy Volunteer
- Sponsor
- Biogen
- Enrollment
- 112
- Locations
- 1
- Primary Endpoint
- Functional Magnetic Resonance Imaging Data During Working Memory Task
- Status
- Completed
- Last Updated
- 6 years ago
Overview
Brief Summary
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
This study was previously posted by Pfizer, Inc. Sponsorship of the trial was transferred to Biogen.
Investigators
Eligibility Criteria
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 \[lbs\]);
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
Arms & Interventions
Placebo
Participants will receive placebo as a single oral dose.
Intervention: Placebo
Cohort 1
Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose.
Intervention: PF-04958242
Cohort 2
Participants will receive 0.15 mg of PF-04958242 as a single oral dose.
Intervention: PF-04958242
Outcomes
Primary Outcomes
Functional Magnetic Resonance Imaging Data During Working Memory Task
Time Frame: 59 Minutes Post-dose
Arterial Spin Labeling Data
Time Frame: 39 Minutes Post-dose
Secondary Outcomes
- Number of Participants Experiencing Adverse Events and Serious Adverse Events(Up to Day 11)