Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Participants
2016年12月5日 更新者：Janssen Research & Development, LLC
A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, and Pharmacokinetics of JNJ-55375515 in Healthy Subjects
The purpose of this study is to assess the safety, tolerability, and pharmacokinetics of JNJ-55375515 in healthy participants after administration of single and multiple oral doses.
研究概览
详细说明
This is a randomized (study medication assigned to participants by chance), double-blind (neither the investigator nor the participants know what treatment the participant is receiving), placebo-controlled (an inactive comparator treatment that has no study drug in it), single center study in healthy male participants and female participants of non-childbearing potential (surgically sterile or post menopausal), aged 18 to 58 years inclusive.
This study will consist of two parts; a Single Ascending Dose (SAD) part and a Multiple Ascending Dose (MAD) part.
The SAD will consist of 6 escalating dose cohorts.
Participants in each cohort will be randomized to receive a single oral administration of JNJ-55375515 or placebo after an overnight fast.
The planned doses of JNJ-55375515 range from 0.75 to 100 milligrams (mg).
Participants in an additional cohort will be dosed in the fed state to determine the effects of food on the safety, tolerability and pharmacokinetics of JNJ-55375515.
An additional optional cohort may be evaluated to further explore the safety, tolerability, pharmacokinetics, and pharmacodynamics of JNJ-55375515, with the maximal dose not exceeding 200 mg.
The study duration for participants in the SAD part of the study will be approximately 2 to 5.5 weeks, including eligibility Screening.
The MAD will consist of 3 cohorts of 9 participants.
Participants will receive once daily oral doses of JNJ-55375515 or placebo for 10 consecutive days.
The study duration for participants in the MAD part of this study will be approximately 3 to 7 weeks including the eligibility Screening.
The Safety of Participants will be monitored throughout the study.
研究类型
介入性
注册 (实际的)
175
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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Merksem、比利时
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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
18年 至 58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 healthy on the basis of physical and neurological examination, medical history, vital signs, and electrocardiogram (ECG), and have a body mass index of 18-30 kilogram / square meter (kg/m^2) and a body mass of not less than 50 kg.
- Participant must be healthy on the basis of clinical laboratory tests performed at Screening and Day -1.
- Female participants must not be of childbearing potential by either being post-menopausal or permanently sterilized.
- Female participants must not be pregnant.
- Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol, including contraception.
- Each participant must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and are willing to participate in the study.
Exclusion Criteria:
- Participant has current, or history of, clinically significant medical or psychiatric illness.
- Participant has any condition for which participation would not be in the best interest of the participant or that could prevent, limit, or confound any protocol specified assessments or the interpretation of the study results.
- Participant has a personal history of, or a first degree relative with a history of, acute angle-closure glaucoma, or participant has significant hyperopia (far-sightedness).
- Participant has a QT corrected according to Fridericia's formula (QTcF) interval greater than (>) 450 msec (male) or >470 msec (female), or has a history of additional risk factors for torsades de pointes.
- Participant has history of vasovagal episodes.
- Participant has history of drug, alcohol, nicotine, or caffeine abuse.
- Participant who is breastfeeding.
- Participant has had major surgery within 12 weeks of Screening, has donated more than 450 milliliters (mL) of blood, or has acute loss of equivalent amount of blood within 90 days of study drug administration.
- Participant has positive fecal occult blood test results at Screening.
- Participant has history of clinically significant drug and/or food allergies.
- Participant has received another investigational drug within 1 month or a period of less than 10 times the drug's half-life, whichever is longer, before the planned first dose of study drug
- Participant is an employee, or family member of an employee, of the study site.
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：单组作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：Part 1: Single Ascending Dose (SAD)
Participants will receive 0.75 milligrams (mg) of JNJ-55375515 (starting dose) or Placebo on Day 1. Dose of the study medication will be escalated sequentially up to a maximum of 200 mg.
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Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
参与者将接受匹配的安慰剂。
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实验性的：Part 2: Multiple Ascending Dose (MAD)
Participants will receive JNJ-55375515 (at doses determined based on the data from the SAD part) or Placebo from Day 1 to 10.
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Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
参与者将接受匹配的安慰剂。
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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 Adverse Events
大体时间：Up to Day 7 after discharge
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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.
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Up to Day 7 after discharge
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Part 1: Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：Up to Day 5
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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Up to Day 5
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Part 1: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
大体时间：Up to Day 5
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The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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Up to Day 5
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Part 1: Elimination Half-Life (t1/2)
大体时间：Up to Day 5
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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).
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Up to Day 5
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Part 1: Maximum Observed Plasma Concentration (Cmax)
大体时间：Up to Day 5
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The Cmax is the maximum observed concentration.
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Up to Day 5
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Part 2: Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：Up to Day 15
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The Tmax is defined as actual sampling time to reach maximum observed concentration.
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Up to Day 15
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Part 2: Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
大体时间：Up to Day 15
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The AUC(0-t) is the area under the plasma concentration-time curve from time zero to any time 't'.
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Up to Day 15
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Part 2: Elimination Half-Life (t1/2)
大体时间：Up to Day 15
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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).
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Up to Day 15
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Part 2: Maximum Observed Plasma Concentration (Cmax)
大体时间：Up to Day 15
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The Cmax is the maximum observed concentration.
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Up to Day 15
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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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Maximum Tolerated Dose (MTD) of JNJ-55375515
大体时间：Up to Day 5 in part 1; up to Day 15 in part 2
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The maximum tolerated dose is defined as the dose below the dose at which 2 or more subjects receiving the same dose of active study drug experience the same dose-limiting toxicity or have the same severe adverse event, or below the level at which the Investigator and Sponsor agree that an unacceptable dose-limiting toxicity has occurred in a single subject treated with active study drug.
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Up to Day 5 in part 1; up to Day 15 in part 2
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Part 1: The Effect of Food on the Number of Adverse Events
大体时间：Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Tmax)
大体时间：Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Maximum Observed Plasma Concentration (Cmax)
大体时间：Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Elimination Half-Life (t1/2)
大体时间：Baseline up to Day 5
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Baseline up to Day 5
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Part 1: The Effect of Food on Area Under the Plasma Concentration-Time Curve From Time Zero to Time 't' (AUC[0-t])
大体时间：Baseline up to Day 5
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Baseline up to Day 5
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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
2015年11月1日
初级完成 (实际的)
2016年9月1日
研究完成 (实际的)
2016年9月1日
研究注册日期
首次提交
2015年11月18日
首先提交符合 QC 标准的
2015年12月2日
首次发布 (估计)
2015年12月7日
研究记录更新
最后更新发布 (估计)
2016年12月6日
上次提交的符合 QC 标准的更新
2016年12月5日
最后验证
2016年12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
- CR108063
- 2015-003817-31 (EudraCT编号)
- 55375515EDI1001 (其他标识符：Janssen Research & Development, LLC)
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.
JNJ-55375515的临床试验
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Janssen Research & Development, LLC招聘中
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Janssen Research & Development, LLC完全的
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Janssen Research & Development, LLC完全的
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Janssen Research & Development, LLC完全的