Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Participants
23 de marzo de 2016 actualizado por: Janssen-Cilag International NV
A Double-blind, Randomized, Controlled, 3-way Crossover, Pilot Study to Evaluate the Duration of Effects on Simulated Car Driving and Cognitive Performance After a Single Dose of JNJ-42847922, Zolpidem and Placebo in Healthy Subjects
The purpose of the study is to evaluate the effects of JNJ-42847922, compared to zolpidem and placebo, on driving performance as assessed by the mean difference of standard deviation of lateral position (SDLP) after forced awakening using a validated driving simulator test at 2, 4, 6 and 8 hours post-evening dose.
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
This is a single center, double-blind (neither Investigator nor participant knows which treatment the participant receives), randomized (study drug assigned by chance), 3-way cross-over (the same medications provided to all participants but in different sequence), pilot study in healthy male and female participants.
Participants will be randomly assigned to 1 of 6 treatment and planning sequences.
The study will consist of 3 parts: Screening Phase (between 21 days and 1 day prior to the first dose administration), a 3-way crossover double-blind, single dose treatment Phase and follow-up Phase (7 to 10 days after last dose administration).
The maximum study duration for each participant will not exceed 7 weeks.
The double-blind crossover treatment phase will consist of 3 treatment periods separated by a washout period of at least 3 days between dosing.
Participants will receive either Treatment A (2 capsules of 20 milligram [mg] JNJ-42847922), Treatment B (10 mg zolpidem and 1 placebo capsule) or Treatment C (2 placebo capsules) in each treatment period.
Driving performance will be assessed primarily by the mean difference of standard deviation of lateral position (SDLP) from an on road driving test.
Participants' safety will be monitored throughout the study.
Tipo de estudio
Intervencionista
Inscripción (Actual)
36
Fase
- Fase 1
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Leiden, Países Bajos
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 55 años (Adulto)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Body mass index (BMI) (weight [kg]/height^2[m^2]) between 18 and 30 kg/m^2 (inclusive)
- Men who are sexually active with a woman of childbearing potential must agree to use a condom, and all men must not donate sperm during the study and for 3 months after receiving the last dose of study drug. In addition, for men who have not had a vasectomy, their female partners should also use an appropriate method of birth control for at least the same duration
- A woman of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test pre-dose on Day 1 of each period
- A woman must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for at least 3 months after receiving the last dose of study drug
- Participant has a valid driving license for more than 3 years, has driven at least 5000 kilometer (km) in the past year and is driving a car regularly
- Women of childbearing potential must practice a highly effective method of birth control consistent with local regulations regarding the use of birth control methods for participants participating in clinical studies (that is, one that results in a less than 1 percent per year failure rate when used consistently and correctly)
Exclusion Criteria:
- Participant has clinically significant liver or renal insufficiency; cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic (including cataplexy and cognitive impairment), hematologic, rheumatologic, psychiatric, or metabolic disturbances. A significant primary sleep disorder is exclusionary
- Clinically significant abnormal values for hematology, clinical chemistry, or urinalysis at screening as deemed appropriate by the investigator
- Subject has a history of substance or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 6 months before screening or positive test result(s) for alcohol and/or drugs of abuse (opiates [including methadone], cocaine, amphetamines, methamphetamines, cannabinoids, barbiturates, ecstasy and benzodiazepines) at screening or admission on Day 1 of each study period
- Current suicidal or homicidal ideation/intent/behavior
- Serology positive for hepatitis B surface antigen (HBsAg), hepatitis C antibodies (HCV) or Human immunodeficiency virus (HIV) antibodies
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Group 1 (Sequence ABC)
Participants will receive Treatment A (2 capsules of 20 milligram [mg] JNJ-42847922) in Period 1, Treatment B (10 mg zolpidem and 1 placebo capsule) in Period 2 and Treatment C (2 placebo capsules) in Period 3 with a washout interval of at least 3 days between treatment periods.
Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 2 (Sequence BCA)
Participants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods.
Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 3 (Sequence CAB)
Participants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods.
Participants randomized to this group will be assessed for pharmacodynamic testing at 2 and 6 hours after dosing.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 4 (Sequence ABC)
Participants will receive Treatment A in Period 1, Treatment B in Period 2 and Treatment C in Period 3 with a washout interval of at least 3 days between treatment periods.
Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing.
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JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 5 (Sequence BCA)
Participants will receive Treatment B in Period 1, Treatment C in Period 2 and Treatment A in Period 3 with a washout interval of at least 3 days between treatment periods.
Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing.
|
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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Experimental: Group 6 (Sequence CAB)
Participants will receive Treatment C in Period 1, Treatment A in Period 2 and Treatment B in Period 3 with a washout interval of at least 3 days between treatment periods.
Participants randomized to this group will be assessed for pharmacodynamic testing at 4 and 8 hours after dosing.
|
JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
Matching Placebo will be administered orally.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Periodo de tiempo: up to 8 hours post-dose
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The SDLP will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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up to 8 hours post-dose
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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The MLP will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Distance-keeping Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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Distance-keeping will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Mean Speed (MS) Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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The MS will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Standard Deviation of Speed (SDS) Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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The SDS will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Number of Head movements Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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Number of head movements will be measured from a simulated road tracking test over about 15 minutes.
Instructed speed is 100 kilometer (km)/hour.
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2 to 8 hours post-dose
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Reaction-time Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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Reaction-time will be assessed by 10 minutes of special and unexpected traffic events.
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2 to 8 hours post-dose
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Inhibition-time Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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Inhibition-time will be assessed by 10 minutes of special and unexpected traffic events.
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2 to 8 hours post-dose
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Alertness-time Assessed From an On-road Driving Test
Periodo de tiempo: 2 to 8 hours post-dose
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Alertness-time will be assessed by 10 minutes of special and unexpected traffic events.
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2 to 8 hours post-dose
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Drive safety Score (DSS)
Periodo de tiempo: 2 to 8 hours post-dose
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The DSS is a composite score of driving simulator behavior ranging from 0-10, related to actual driving performance.
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2 to 8 hours post-dose
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Subjective assessment of driving performance using visual analog scale
Periodo de tiempo: 2 to 8 hours post-dose
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Participants indicated the perceived quality of their driving performance on a visual analog scale, which ranged from 0 ('I drove exceptionally poorly') to 20 ('I drove exceptionally well') around a midpoint of 'I drove normally'.
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: Detection (DET) Test
Periodo de tiempo: 2 to 8 hours post-dose
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Simple reaction time task measuring processing speed; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: Identification (IDN) Test
Periodo de tiempo: 2 to 8 hours post-dose
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Choice reaction time paradigm measuring attention; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: One Back (OBK) Test
Periodo de tiempo: 2 to 8 hours post-dose
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Working memory measure; mean of the log10 transformed reaction times for correct responses (lower score = better performance).
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: One card learning
Periodo de tiempo: 2 to 8 hours post-dose
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A visual recall test scored using arcsine transformation of the proportion of correct responses.
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2 to 8 hours post-dose
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Computerized Cognitive Test Battery: Trailmaking Test Form B (TMT-B)
Periodo de tiempo: 2 to 8 hours post-dose
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TMT-B is a paper-and-pencil measure of divided attention and executive function (tracking, sequencing).
The participant is instructed do draw a line to connect a set of 25 consecutively numbered and lettered circles, alternating sequentially between numbers and letters.
The participant is instructed to work as quickly as possible while still maintaining accuracy.
The test requires approximately 2 minutes to complete, alternate forms are available.
Scores include time to completion and errors.
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2 to 8 hours post-dose
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Postural Stability Test
Periodo de tiempo: 2 to 8 hours post-dose
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Postural stability will be measured by body sway meter which allows measurement of body movements in a single plane.
Body sway is measured with a pot string meter (celesco) based on the Wright ataxiameter (Wright, 1971).
With a string attached to the waist, all body movements over a period of time are integrated and expressed as millimeter sway.
The total period of body sway measurement will be two minutes.
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2 to 8 hours post-dose
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Karolinska Sleepiness Scale (KSS) Score
Periodo de tiempo: 2 to 8 hours post-dose
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The KSS is a participant-reported assessment used to rate sleepiness on a scale of 1 to 9, ranging from 1 (extremely alert) to 9 (very sleepy, great effort to keep awake, fighting sleep).
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2 to 8 hours post-dose
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Periodo de tiempo: up to Follow-up (7-10 days after last dose of study drug)
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An AE was any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
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up to Follow-up (7-10 days after last dose of study drug)
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Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922
Periodo de tiempo: Pre-dose and Day 1 post-dose
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Relationship between duration of changes in driving ability and plasma concentrations of JNJ-42847922 will be reported.
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Pre-dose and Day 1 post-dose
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de noviembre de 2015
Finalización primaria (Actual)
1 de febrero de 2016
Finalización del estudio (Actual)
1 de febrero de 2016
Fechas de registro del estudio
Enviado por primera vez
15 de octubre de 2015
Primero enviado que cumplió con los criterios de control de calidad
15 de octubre de 2015
Publicado por primera vez (Estimar)
19 de octubre de 2015
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
24 de marzo de 2016
Última actualización enviada que cumplió con los criterios de control de calidad
23 de marzo de 2016
Última verificación
1 de marzo de 2016
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CR108056
- 42847922EDI1011 (Otro identificador: Janssen-Cilag International NV)
- 2015-004203-24 (Número EudraCT)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .