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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01826786
• Other study ID #: CR100975
• Secondary ID: 42165279ANX1001
• Status: Completed
• Phase: Phase 1
• First received: April 4, 2013
• Last updated: October 14, 2014
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: October 2014
• Source: Janssen Research & Development, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Anxiety Disorders
• Healthy

Intervention

Drug:
• JNJ-42165279 (100 mg)
JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
• Placebo
Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Startle response	Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner.	Day 4	No
Secondary	The number of volunteers who experience adverse events as a measure of safety and tolerability.		Day -28 to Day 18	Yes