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

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

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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JNJ-42165279 (100 mg)

Group Type EXPERIMENTAL

JNJ-42165279 (100 mg)

Intervention Type DRUG

JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.

Interventions

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JNJ-42165279 (100 mg)

JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.

Intervention Type DRUG

Placebo

Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes