- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 1
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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La Jolla, California, Estados Unidos
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador de placebos: Placebo
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Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
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Experimental: JNJ-42165279 (100 mg)
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JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)
Periodo de tiempo: Day 4
|
BOLD-fMRI percent signal changes during an Emotional Face Processing task.
|
Day 4
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brain activity patterns in multiple areas of the emotional brain neurocircuitry
Periodo de tiempo: Day 4
|
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
Periodo de tiempo: 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.
Periodo de tiempo: Day -28 to Day 18
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Day -28 to Day 18
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR100975
- 42165279ANX1001 (Otro identificador: Janssen Research & Development, LLC)
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