HealthyPhase 1NCT01826786
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers
A Phase 1 study testing JNJ-42165279 (100 mg) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- JNJ-42165279 (100 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy
- Being tested
- JNJ-42165279 (100 mg), Placebo
- Keywords
- Healthy, Anxiety Disorders, Anxiety Modulation, Male
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JNJ-42165279 (100 mg)Drug
JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
PlaceboDrug
Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| JNJ-42165279 (100 mg) | Experimental | Not described Receives: Drug: JNJ-42165279 (100 mg) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 4
Secondary outcomes (3)
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).
Measured: Day 4
Startle response
Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner.
Measured: Day 4
The number of volunteers who experience adverse events as a measure of safety and tolerability.
Measured: Day -28 to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826786
- Sponsor's protocol ID
- CR100975
- Other IDs
- 42165279ANX1001
- Status last verified
- Oct 2014
- First submitted
- 4 Apr 2013
- Last updated
- 15 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01826786
- Acronym / sponsor ID
- CR100975
- Conditions
- Healthy
- Keywords
- Healthy, Anxiety Disorders, Anxiety Modulation, Male
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JNJ-42165279 (100 mg) | Experimental | Drug: JNJ-42165279 (100 mg) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JNJ-42165279 (100 mg)JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days. | Drug | JNJ-42165279 (100 mg) |
| PlaceboMatching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days. | Drug | Placebo |
Primary outcome
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)
Time frame: Day 4
BOLD-fMRI percent signal changes during an Emotional Face Processing task.
3 secondary outcomes
Brain activity patterns in multiple areas of the emotional brain neurocircuitry
Time frame: Day 4
Startle response
Time frame: Day 4
The number of volunteers who experience adverse events as a measure of safety and tolerability.
Time frame: Day -28 to Day 18
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing JNJ-42165279 (100 mg) in people with Healthy, run by Janssen Research & Development, LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior) (time frame: Day 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2014.