A Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Participants
2017年7月6日 更新者:Janssen Sciences Ireland UC
A Double-blind, Placebo-controlled, Randomized, Single Ascending Dose Study to Investigate Safety, Tolerability, and Pharmacokinetics of JNJ 53718678 in Healthy Japanese Adult Subjects
The purpose of this study is to investigate the safety, tolerability, and pharmacokinetics of three dosages (250, 500, and 1000 milligram [mg], or maximum tolerated dose [MTD]) of JNJ 53718678 when administered as single dose in fasting conditions in healthy Japanese adult participants in 3 cohorts.
研究概览
详细说明
This is a Phase 1, single center, double-blind (study in which neither the researchers nor the participants know what treatment the participants are receiving), placebo-controlled (study in which the experimental treatment or procedure is compared to placebo treatment), randomized (study medication assigned to participants by chance) study in healthy Japanese adult participants residing outside of Japan.
The study will consist of a Screening phase, an In-clinic treatment phase, and a follow-up phase.
The study duration for each participant will be approximately 6 weeks from Screening (Day -28 to Day -2) to follow up visit (Day 10 to 14).
Participants will be randomly assign to receive JNJ 53718678 or placebo, at planned dose of 250, 500 and 1000 milligram (mg).
Planned doses will be stepwise escalated, if the safety and tolerability of the preceding dose(s) are found to be acceptable, and the maximum tolerated dose (MTD) is not reached.
De-escalation may be performed in order to study an intermediate dose.
The safety, tolerability and pharmacokinetic (PK) profile of JNJ-53718678 will primarily be evaluated.
Participants' safety will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
24
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
-
-
-
Harrow、英国
-
-
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
20年 至 55年 (成人)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Participant must be a Japanese participant who has resided outside Japan for no more than 5 years and whose parents and grandparents are Japanese as determined by participant's verbal report
- Participant must be healthy on the basis of a medical evaluation that reveals the absence of any clinically relevant abnormality and includes a physical examination (including height and body weight measurement and skin examination), medical history, vital signs (body temperature, systolic blood pressure, diastolic blood pressure, pulse rate, orthostatic hypotension, and respiratory rate), and the results of blood biochemistry, blood coagulation and hematology tests, a urinalysis, and a hematest performed at Screening, on Day -1, or Day 1 pre-dose, whichever is applicable. If there are abnormalities, the participant may be included only if the Investigator judges the abnormalities or deviations from normal to be not clinically significant. This determination must be recorded in the participant's source documents and initialed by the Investigator
- Female participants must be of non-childbearing potential: postmenopausal for at least 2 years (amenorrheal for at least 2 years and a serum follicle stimulating hormone [FSH] level greater than [>] 40 international unit per liter [IU/L] or milli IU per milliliter [mIU/mL]), or surgically sterile (have had a total hysterectomy, bilateral oophorectomy, or bilateral tubal ligation/bilateral tubal clips without reversal operation), or otherwise incapable of becoming pregnant
- Participant must be a non-smoker for at least one month prior to Screening
- Participant must have a body mass index (BMI) (weight [kilogram{kg}]/height^2 [meter^2]) between 18 and 30 kg/m^2 (inclusive), and body weight not less than 50 kg
Exclusion Criteria:
- Participant has a history of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease, coagulation disorders (including any abnormal bleeding or blood dyscrasias), lipid abnormalities, significant pulmonary disease, including bronchospastic respiratory disease, diabetes mellitus, hepatic or renal insufficiency, thyroid disease, neurologic or psychiatric disease, infection, or any other illness that the Investigator considers should exclude the subject or that could interfere with the interpretation of the study results
- Participant with any history of clinically significant skin disease such as, but not limited to, dermatitis, eczema, drug rash, psoriasis, food allergy, and urticaria
- Clinically significant abnormal physical examination, vital signs, or 12 lead electrocardiogram (ECG) at Screening, on Day -1 (physical examination only), and pre-dose on Day 1, as deemed appropriate by the Investigator
- Participants with lack of good/reasonable venous access
- Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or, history of risk factors for Torsade de Pointes syndrome (for example, hypokalemia, family history of long QT Syndrome
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:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:JNJ 53718678 250 milligram (mg)
Participants will receive either single oral dose of 250 mg of JNJ 53718678 or matching placebo on Day 1.
|
JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
|
|
实验性的:JNJ 53718678 500 mg
Participants will receive either single oral dose of 500 mg of JNJ 53718678 or matching placebo on Day 1.
|
JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
|
|
实验性的:JNJ 53718678 1000 mg
Participants will receive either single oral dose of 1000 mg of JNJ 53718678 or matching placebo on Day 1.
|
JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
|
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 |
|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax)
大体时间:Up to 72 hours post dose
|
The Cmax is the maximum observed plasma concentration.
|
Up to 72 hours post dose
|
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间:Up to 72 hours post dose
|
The Tmax is defined as actual sampling time to reach maximum observed JNJ 53718678 concentration.
|
Up to 72 hours post dose
|
|
Time to Last Quantifiable Plasma Concentration (Tlast)
大体时间:Up to 72 hours post dose
|
The Tlast is the time to last observed quantifiable plasma concentration.
|
Up to 72 hours post dose
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC [0-last])
大体时间:Up to 72 hours post dose
|
The AUC (0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time.
|
Up to 72 hours post dose
|
|
Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
大体时间:Up to 72 hours post dose
|
The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
|
Up to 72 hours post dose
|
|
Apparent Initial Elimination Rate Constant (lambda [alpha])
大体时间:Up to 72 hours post dose
|
Apparent initial elimination rate constant, determined by linear regression of the data points within the first elimination phase of the ln-linear plasma concentration-time curve.
|
Up to 72 hours post dose
|
|
Elimination Rate Constant (Lambda[z])
大体时间:Up to 72 hours post dose
|
Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve.
|
Up to 72 hours post dose
|
|
Apparent Initial Elimination Half-life (t1/2[alpha])
大体时间:Up to 72 hours post dose
|
Apparent initial elimination half-life is calculated as 0.693/lambda(alpha).
|
Up to 72 hours post dose
|
|
Elimination Half-Life (t1/2)
大体时间:Up to 72 hours post dose
|
The elimination half-life (t1/2) is the time measured for the plasma concentration to decrease by 1 half to its original concentration.
It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z).
|
Up to 72 hours post dose
|
|
Total Apparent Clearance (CL/F)
大体时间:Up to 72 hours post dose
|
Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
|
Up to 72 hours post dose
|
|
Apparent Volume of Distribution (Vd/F)
大体时间:Up to 72 hours post dose
|
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after subcutaneous dose (Vd/F) is influenced by the fraction absorbed.
|
Up to 72 hours post dose
|
|
Number of Participants With Adverse Events
大体时间:From sign of informed consent up to end of study (Day 14)
|
An adverse event is 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.
|
From sign of informed consent up to end of study (Day 14)
|
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)
2015年4月1日
初级完成 (实际的)
2015年7月15日
研究完成 (实际的)
2015年7月15日
研究注册日期
首次提交
2015年3月20日
首先提交符合 QC 标准的
2015年3月20日
首次发布 (估计)
2015年3月25日
研究记录更新
最后更新发布 (实际的)
2017年7月11日
上次提交的符合 QC 标准的更新
2017年7月6日
最后验证
2017年7月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- CR107003
- 53718678RSV1004 (其他标识符:Janssen Sciences Ireland UC)
- 2014-005410-36 (EudraCT编号)
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
在美国制造并从美国出口的产品
不
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