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

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: JNJ-42165279 (100 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01826786

42165279ANX1001 (Other Identifier)

CR100975

Details and patient eligibility

About

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.

Full 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.

Enrollment: 43 patients

Sex: Male

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

43 participants in 2 patient groups, including a placebo group

JNJ-42165279 (100 mg)

Experimental group

Treatment:

Drug: JNJ-42165279 (100 mg)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo