Study to Evaluate the Safety and Tolerability of a Once Daily Dose of 50 mg E2609 in Healthy Japanese Subjects
2017年4月14日 更新者：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.
研究概览
研究类型
介入性
注册 (实际的)
16
阶段
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Fukuoka、日本
- Eisai Trial Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
50年 至 85年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：基础科学
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：E2609 50 mg
Participants will receive E2609 50 milligrams (mg) orally once a day for 14 days.
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tablet
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安慰剂比较：Placebo
Participants will receive matching placebo orally once a day for 14 days.
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药片
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of participants with any serious adverse event and number of participants with any non-serious adverse event
大体时间：up to Day 35 (Termination/Visit 5)
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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.
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up to Day 35 (Termination/Visit 5)
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Number of participants with an abnormal, clinically significant laboratory test value
大体时间：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)
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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.
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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)
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Number of participants with an abnormal, clinically significant vital sign value
大体时间：Screening; Baseline; up to Day 62
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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.
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Screening; Baseline; up to Day 62
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Number of participants with an abnormal, clinically significant electrocardiogram (ECG) finding
大体时间：Screening; Baseline; up to Day 62
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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.
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Screening; Baseline; up to Day 62
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Clinical assessment of suicidality per the suicidality rating scale
大体时间：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)
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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.
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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)
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Mean quality of sleep score per the Waketime Questionnaire, if necessary
大体时间：up to Day 62
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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.
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up to Day 62
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Mean maximum observed concentration (Cmax) of E2609 and metabolites on Day 1 and Day 14
大体时间：Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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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.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Mean minimum observed concentration (Cmin) of E2609 and metabolites on Day 1 and Day 14
大体时间：Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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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.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Median time from dosing to reach Cmax (tmax) of E2609 and metabolites on Day 1 and Day 14
大体时间：Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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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.
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Days 1 and 14: predose; 1, 2, 3, 4, 6, and 10 hours postdose
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Mean area under the concentration-time curve (AUC) from time 0 to 24 hours for E2609 and metabolites on Day 1 and Day 14
大体时间：Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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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).
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Mean terminal elimination half-life (t1/2) following the last day of dosing (Day 14) of E2609 and metabolites
大体时间：Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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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.
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Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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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
大体时间：Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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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.
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Mean accumulation ratio for AUC, Cmax, and Cmin (Rac) for E2609 and metabolites on Day 1 and Day 14
大体时间：Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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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
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Days 1 and 14: 1, 2, 3, 4, 6, 10, and 24 hours postdose
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Apparent clearance at steady state (CLss/F) of E2609 on Day 14
大体时间：Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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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.
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Day 14: 1, 2, 3, 4, 6, 10, 24, 48, 72, 96, and 144 hours postdose
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Number of participants with polymorphisms of N-acetyltransferase 2 (NAT2)
大体时间：Day 1
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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.
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Day 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月14日
初级完成 (实际的)
2017年3月29日
研究完成 (实际的)
2017年4月11日
研究注册日期
首次提交
2017年2月10日
首先提交符合 QC 标准的
2017年2月14日
首次发布 (实际的)
2017年2月16日
研究记录更新
最后更新发布 (实际的)
2017年4月18日
上次提交的符合 QC 标准的更新
2017年4月14日
最后验证
2017年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.