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

Phase 1

Completed

• Conditions: Healthy Volunteer
• Interventions: Drug: PF-04958242; Drug: Placebo

• Registration Number: NCT01365338
• Lead Sponsor: Biogen

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.

Study Timeline

• Study First Submitted: 2011-05-11
• Study First Submitted QC: 2011-06-02
• Study First Posted: 2011-06-03
• Study Start: 2011-06-24
• Primary Completion: 2012-12-14
• Study Completion: 2012-12-14
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-20
• Last Update Posted: 2019-12-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 2	PF-04958242	Participants will receive 0.15 mg of PF-04958242 as a single oral dose.
Cohort 1	PF-04958242	Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose.
Placebo	Placebo	Participants will receive placebo as a single oral dose.

Primary Outcome Measures

Name	Time	Method
Functional Magnetic Resonance Imaging Data During Working Memory Task	59 Minutes Post-dose
Arterial Spin Labeling Data	39 Minutes Post-dose

Secondary Outcome Measures

Name	Time	Method
Number of Participants Experiencing Adverse Events and Serious Adverse Events	Up to Day 11	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.

Trial Locations

Locations (1)

Research Site; 🇺🇸 New Haven, Connecticut, United States