A Non-interventional Functional Magnetic Resonance Imaging (fMRI) Study and Behavioral Assessment in Healthy Participants

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

Total Enrollment

31 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-02-29

Brief Summary

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This is a single center non-interventional study in healthy participants for behavioral assessment and fMRI assessments. The study will consist of 2 parts. Part A will involve 5 participants and will study the implementation of the behavioral tests and identify potential issues. Part B will involve 30 participants and will study the test-retest reliability. Duration of participation for each participant will be 30 days for Part A (28 days screening period and 2 days of study visit) and 48 days for Part B (28 days screening period and 2 study visits of 2 days each separated by a period of 14 days).

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Detailed Description

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Conditions

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Healthy Volunteer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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All Participants

Healthy participants will undergo behavioral assessment and fMRI.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Healthy participants, as determined by screening assessments and principal investigator judgment
* A body mass index (BMI) between 18 to 30 kilogram per square meter (kg/m\^2) inclusive with body weight in the range of 50 to 100 kg
* The participant must be able to comply with study requirements as judged by the principal investigator
* Women participants who are not postmenopausal or surgically sterile agree to use effective contraception throughout the study

Exclusion Criteria

* Female participant with child-bearing potential or a positive blood pregnancy test
* Lactating women participants
* Any history of alcohol and/or drug abuse, addiction or suspicion of regular consumption of drugs of abuse
* Use of any psychoactive medication, or medications known to have effect on central nervous system (CNS) or blood flow
* Any contraindications for magnetic resonance imaging (MRI) scans or any brain/head abnormalities restricting MRI eligibility

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes