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

Roche

Status: Completed

Conditions: Healthy Volunteer

Study type: Observational

Funder types: Industry

Identifiers

NCT02560142

BP29791

Details and patient eligibility

About

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).

Enrollment: 31 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

31 participants in 1 patient group

All Participants

Description:

Healthy participants will undergo behavioral assessment and fMRI.