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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: JNJ-42165279 (100 mg); Drug: Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Janssen Research & Development, LLC

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 4, 2013
• First Submitted That Met QC Criteria: April 4, 2013
• First Posted (Estimate): April 9, 2013

Study Record Updates

• Last Update Posted (Estimate): October 15, 2014
• Last Update Submitted That Met QC Criteria: October 14, 2014
• Last Verified: October 1, 2014

More Information

Terms related to this study

• Keywords: Healthy; Male; Anxiety Disorders; Anxiety Modulation
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; JNJ-42165279
• Other Study ID Numbers: CR100975; 42165279ANX1001 (Other Identifier: Janssen Research & Development, LLC)