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 março de 2016 atualizado 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.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Real)
36
Estágio
- Fase 1
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Leiden, Holanda
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
18 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição cruzada
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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.
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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 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Standard Deviation of Lateral Position (SDLP) Assessed From an On-road Driving Test
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Lateral Position (MLP) Assessed From an On-road Driving Test
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de novembro de 2015
Conclusão Primária (Real)
1 de fevereiro de 2016
Conclusão do estudo (Real)
1 de fevereiro de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
15 de outubro de 2015
Enviado pela primeira vez que atendeu aos critérios de CQ
15 de outubro de 2015
Primeira postagem (Estimativa)
19 de outubro de 2015
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
24 de março de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de março de 2016
Última verificação
1 de março de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- CR108056
- 42847922EDI1011 (Outro identificador: Janssen-Cilag International NV)
- 2015-004203-24 (Número EudraCT)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .