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NCT01365338

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

NCT ID: NCT01365338

Last Updated: 2019-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-24

Study Completion Date

2012-12-14

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.

Conditions

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Healthy Volunteer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Placebo

Participants will receive placebo as a single oral dose.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered as specified in the treatment arm

Cohort 1

Participants will receive 0.075 milligrams (mg) of PF-04958242 as a single oral dose.

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

Administered as specified in the treatment arm

Cohort 2

Participants will receive 0.15 mg of PF-04958242 as a single oral dose.

Group Type EXPERIMENTAL

PF-04958242

Intervention Type DRUG

Administered as specified in the treatment arm

Interventions

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Placebo

Administered as specified in the treatment arm

Intervention Type DRUG

PF-04958242

Administered as specified in the treatment arm

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role collaborator

Biogen

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Biogen

Locations

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Research Site

New Haven, Connecticut, United States

Site Status

Research Site

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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B1701003

Identifier Type: -

Identifier Source: org_study_id