- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- La phase 1
Contacts et emplacements
Lieux d'étude
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California
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La Jolla, California, États-Unis
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
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Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
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Expérimental: JNJ-42165279 (100 mg)
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JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Brain activity patterns in the amygdala (almond-shaped part of the brain associated with motivation and emotional behavior)
Délai: Day 4
|
BOLD-fMRI percent signal changes during an Emotional Face Processing task.
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Day 4
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Brain activity patterns in multiple areas of the emotional brain neurocircuitry
Délai: 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
Délai: 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.
Délai: Day -28 to Day 18
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Day -28 to Day 18
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CR100975
- 42165279ANX1001 (Autre identifiant: Janssen Research & Development, LLC)
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