- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01826786
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Volunteers
The Effects of JNJ-42165279 on the Neural Basis of Anxiety Disorders in Healthy Male Subjects
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Fase 1
Kontakter og lokationer
Studiesteder
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California
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La Jolla, California, Forenede Stater
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Grundvidenskab
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Placebo
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Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
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Eksperimentel: JNJ-42165279 (100 mg)
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JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)
Tidsramme: Day 4
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BOLD-fMRI percent signal changes during an Emotional Face Processing task.
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Day 4
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Brain activity patterns in multiple areas of the emotional brain neurocircuitry
Tidsramme: Day 4
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BOLD-fMRI percent signal changes during emotionally-provoking tasks (pictures of emotional faces, periods of breathing restriction, presentations of a loud noise).
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Day 4
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Startle response
Tidsramme: Day 4
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Eye blink responses to a loud noise during 2 emotionally-provoking tasks outside of the MRI scanner.
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Day 4
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The number of volunteers who experience adverse events as a measure of safety and tolerability.
Tidsramme: Day -28 to Day 18
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Day -28 to Day 18
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CR100975
- 42165279ANX1001 (Anden identifikator: Janssen Research & Development, LLC)
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