The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the potential efficacy of JNJ-42165279 in treating anxiety disorders through evaluation of brain activation patterns using imaging technology in healthy volunteers.

Detailed Description
-----------------
This is a single site, double-blind (neither investigator nor the participant knows the treatment that the participant receives) study. The study will consist of a screening phase (1-2 visits), a treatment phase (4 visits), and a post treatment phase (follow-up safety visit, 7 to 14 days after the last dose of the study drug). During the screening phase, participants will be evaluated to determine if they meet the study eligibility criteria, which will include collection of blood and urine samples. During the treatment phase, eligible participants will be assigned by chance (like a toss of a coin) to receive either JNJ-42165279 100 mg or placebo once daily during 4 consecutive visits to the clinic. Placebo is an inactive substance that is compared with a drug to test whether the drug has a real effect. The potential of the drug to treat anxiety will be assessed on Day 4 of the treatment phase. The primary assessment, Blood Oxygen Level Dependent Functional Magnetic Resonance Imaging (BOLD-fMRI), will measure brain activity patterns while participants complete 3 emotionally-provoking tasks. Additionally, participants' startle responses (eye blinks) will be evaluated in two emotionally-provoking behavioral tasks outside of the scanner. Questionnaires will be completed to evaluate participants' mood, and blood samples will be collected to measure concentrations of JNJ-42165279 and biomarkers of drug activity. Safety will be monitored throughout the study, including adverse events, vital signs (blood pressure and heart rate), 12-lead ECGs, physical examinations, clinical safety laboratories, evaluation of suicidal risk, and a Walk and Turn test. The total study duration will be approximately 46 days.

Official Title
-----------------
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: JNJ-42165279 (100 mg)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Good general health Body mass index between 18 and 30 kg/m2 and body weight not less than 50 kg Must adhere to required contraception during and for 3 months after study Must agree to not donate sperm during and for 3 months after study Must agree to not donate blood during and for 1 month after study Able to speak and understand English fluently Exclusion criteria: Clinically significant medical or psychiatric illness Any contraindication to magnetic resonance imaging Unable to pass hearing test Alcohol or substance abuse; excessive nicotine or caffeine use Recently received an investigational drug, vaccine, or invasive medical device Unable to abide by protocol restrictions on use of other medications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: JNJ-42165279 (100 mg)<br> | Drug: JNJ-42165279 (100 mg)<br>* JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior) | BOLD-fMRI percent signal changes during an Emotional Face Processing task. | Day 4 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain activity patterns in multiple areas of the emotional brain neurocircuitry | BOLD-fMRI percent signal changes during emotionally-provoking tasks (pictures of emotional faces, periods of breathing restriction, presentations of a loud noise). | Day 4 | 
| Startle response | Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner. | Day 4 | 
| The number of volunteers who experience adverse events as a measure of safety and tolerability. |  | Day -28 to Day 18 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy, Anxiety Disorders, Anxiety Modulation, Male