The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers
2 other identifiers
interventional
43
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 healthy
Started Aug 2013
Longer than P75 for phase_1 healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2013
CompletedFirst Posted
Study publicly available on registry
April 9, 2013
CompletedStudy Start
First participant enrolled
August 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedOctober 15, 2014
October 1, 2014
1 year
April 4, 2013
October 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Brain activity patterns in multiple areas of the emotional brain neurocircuitry
Day 4
Startle response
Day 4
The number of volunteers who experience adverse events as a measure of safety and tolerability.
Day -28 to Day 18
Study Arms (2)
JNJ-42165279 (100 mg)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
La Jolla, California, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2013
First Posted
April 9, 2013
Study Start
August 1, 2013
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
October 15, 2014
Record last verified: 2014-10