Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
14 de abril de 2017 atualizado por: Eisai Co., Ltd.
A Randomized, Double-blind, Placebo-controlled, Multiple Dose Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
Study E2609-J081-014 is a single-center, randomized, double-blind, placebo-controlled study conducted to evaluate the safety and tolerability of multiple oral doses of E2609 50 milligrams (mg), administered once daily for 14 days, in healthy Japanese participants aged 50 to 85 years.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
16
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
-
-
-
Fukuoka, Japão
- Eisai Trial Site
-
-
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
50 anos a 85 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Sim
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Healthy males and females
- Aged 50 to 85 years, inclusive at time of consent
- Body mass index (BMI) of 17.6 to 32 kilograms per meters squared (kg/m^2) at Screening
Exclusion Criteria:
- Personal or family history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (eg, history of head trauma or concussion, previous alcohol abuse, substance abuse)
- A history of cerebrovascular accident or non-vasovagal-related loss of consciousness
- Any clinically significant findings on neurological examination
- A family history of Long QT Syndrome or a presence of other risk factors for Torsades de Pointes (TDP), such as hypokalemia, hypomagnesemia, or hypocalcemia
- History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
- A history of gastrointestinal surgery that may affect the pharmacokinetic profile of E2609 (eg, hepatectomy, nephrotomy, digestive organ resection)
- A known history of clinically significant drug or food allergies or presently experiencing significant seasonal allergy
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: Ciência básica
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Triplo
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: E2609 50 mg
Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days.
|
tablet
|
|
Comparador de Placebo: Placebo
Participants will receive matching placebo orally once a day for 14 days.
|
tábua
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Number of participants with any serious adverse event and number of participants with any non-serious adverse event
Prazo: up to Day 35 (Termination/Visit 5)
|
An adverse event is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related.
A serious adverse event is defined as any adverse event occurring at any dose that results in any of the following outcomes: results in death; is life threatening; results in inpatient hospitalization or prolongation of existing hospitalization; results in a persistent or significant incapacity or substantial disruption of the ability to conduct normal life function; results in a congenital anomaly/birth defect; or can be defined as any other important medical event.
|
up to Day 35 (Termination/Visit 5)
|
|
Number of participants with an abnormal, clinically significant laboratory test value
Prazo: Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
|
Laboratory test values will be assigned a low/normal/high (LNH) classification according to whether the value was below (L), within (N), or above (H) the laboratory parameter's reference range.
Clinical significance will be determined by the Investigator.
|
Screening; Baseline; Days 4, 8, 11, 14, 20 (Out-Patient Follow-up), and 35 (Termination/Visit 5); up to Day 62 (unscheduled Follow-up visits)
|
|
Number of participants with an abnormal, clinically significant vital sign value
Prazo: Screening; Baseline; up to Day 62
|
Vital sign measurements (ie, systolic and diastolic blood pressure [BP] [millimeters of mercury (mmHg)], heart rate [beats per minute], respiratory rate [breaths per minute], body temperature [centigrade]) will be obtained in the supine position by a validated method.
Clinical significance will be determined by the Investigator.
|
Screening; Baseline; up to Day 62
|
|
Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
Prazo: Screening; Baseline; up to Day 62
|
Twelve-lead standard ECGs will be recorded in triplicate.
ECGs will be recorded after the participant has been in the supine position for at least 10 minutes before and during the reading.
In addition, all ECGs will be obtained before blood draws.
Clinical significance will be determined by the Investigator.
|
Screening; Baseline; up to Day 62
|
|
Clinical assessment of suicidality per the suicidality rating scale
Prazo: Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
|
The suicidality rating scale will rate a participant's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent."
The decision to classify an isolated suicidality rating scale response as an adverse event will be exercised through medical and scientific judgment.
|
Baseline (Day -1), 24 hours after dosing (Day 2), Day 15, Day 20, Day 35 (Termination/Visit 5), up to Day 62 (unscheduled Follow-up visits)
|
|
Mean quality of sleep score per the Waketime Questionnaire, if necessary
Prazo: up to Day 62
|
Participants reporting adverse events (AEs) relating to abnormal dreams, nightmares, or sleep terrors will be questioned using the Waketime Questionnaire which is comprised of 5 individual questions.
A participant is asked to rate the quality of their sleep as: 1, Very sound or restful; 2, Sound or restful; 3, Average quality; 4, Restless; or 5, Very restless.
|
up to Day 62
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
Prazo: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
|
Cmax is defined as the maximum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmax.
Cmax will be summarized as the mean and standard deviation for all participants.
|
Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
|
|
Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
Prazo: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
|
Cmin is defined as the minimum observed concentration that a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Cmin.
Cmin will be summarized as the mean and standard deviation for all participants.
|
Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
|
|
Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
Prazo: Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
|
Tmax is defined as the time from dosing to reach the maximum observed concentration a drug achieves in a specified compartment or test area of the body after the drug has been administered.
Using non-compartmental analysis, plasma concentrations of E2609 and metabolites will be analyzed to determine Tmax.
Tmax will be summarized as the median for all participants.
|
Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
|
|
Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
Prazo: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
|
AUC represents the total drug exposure over a defined period of time.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine individual participant estimates of AUC(0-24h).
AUC(0-24h) will be summarized as the mean and standard deviation for all participants and will be expressed in nanograms x hour per milliliter (ng*hr/mL).
|
Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
|
|
Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
Prazo: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
|
Terminal half-life is the time it takes for a substance to lose half of its pharmacologic, physiologic, or radiologic activity.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine t1/2.
t1/2 will be summarized as the mean and standard deviation for all participants and will be expressed in hours.
|
Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
|
|
Mean average concentration calculated as AUCss/tau (Css,av), where tau is the dosing interval, of E2609 and metabolites on Day 1 and Day 14
Prazo: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
|
Css,av is the average steady-state concentration of a drug.
Steady state will be achieved when the rate of E2609 administration and the rate of E2609 elimination are equal.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine the Css,av.
|
Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
|
|
Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
Prazo: Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
|
Rac is equal to the ratio of the AUC during a dosage interval at steady state to the AUC of a dosage interval after the first dose.
Plasma concentrations of E2609 and its metabolites will be analyzed using a non-compartmental analysis approach to determine Rac.
Rac will be summarized as the mean and standard deviation for all participants
|
Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
|
|
Apparent clearance at steady state (CLss/F) of E2609 on Day 14
Prazo: Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
|
CLss/F is the rate and extent of absorption and clearance of E2609 from the plasma.
Plasma concentrations of E2609 and metabolites will be analyzed using a non-compartmental analysis approach to determine CLss/F.
|
Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
|
|
Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
Prazo: Day 1
|
NAT2 genotyping will be conducted, and the predicted phenotype (eg, slow, intermediate, or rapid acetylators) will be used in the statistical analysis to evaluate the relative impact of NAT2 polymorphisms on plasma concentrations of E2609 and/or its metabolites.
|
Day 1
|
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 (Real)
14 de fevereiro de 2017
Conclusão Primária (Real)
29 de março de 2017
Conclusão do estudo (Real)
11 de abril de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
10 de fevereiro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de fevereiro de 2017
Primeira postagem (Real)
16 de fevereiro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de abril de 2017
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de abril de 2017
Última verificação
1 de abril de 2017
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Outros números de identificação do estudo
- E2609-J081-014
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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 .
Ensaios clínicos em Placebo
-
University of OxfordHospital General Universitario Gregorio Marañon; Charite University, Berlin,... e outros colaboradoresAinda não está recrutandoPsicose | Psicose Resistente ao TratamentoEspanha, Reino Unido, Alemanha, Israel, Grécia, Itália, Holanda, Suíça