A Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-38518168 After a Single Oral Dose in Healthy Male Participants.
2013年10月22日 更新者:Janssen Research & Development, LLC
An Open-Label Study to Investigate the Absorption, Metabolism, and Excretion of JNJ-38518168 in Healthy Subjects Following a Single Oral Dose Administration of 14C-JNJ-38518168
The purpose of the study is to investigate the absorption, metabolism, and excretion of 14C JNJ-38518168 in healthy adult male participants after a single oral dose of 30 mg 14C JNJ-38518168.
研究概览
详细说明
This is an open-label (all people know the identity of the intervention), single-center, single-arm (single group), and single-dose study.
This study will include a screening period of 21 days prior to study medication administration.
Six men will be enrolled and admitted to the clinical study unit on the morning of Day -1.
On Day 1, participants will receive a single oral solution dose containing 30 mg of 14C JNJ-38518168 given as an oral solution.
The participants will be confined to the clinical study unit for at least 360 hours after dosing ie, Day -1 through Day 14 and they will be discharged on Day 15; however, participants who, by Day 15, do not meet the discharge criteria will extend their residency in the study unit for up to Day 21.
They will return to the study center 7 to 10 days after discharge for the final safety follow-up.
The study will include the following safety evaluations: adverse event, vital sign, 12-lead electrocardiography, physical examination, and clinical laboratory test.
For each participant the total duration in the study is approximately 6 weeks (including screening and safety follow-up) or 7 weeks for participants who extend the residence up to Day 21.
研究类型
介入性
注册 (实际的)
6
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 55年 (成人)
接受健康志愿者
不
有资格学习的性别
男性
描述
Inclusion Criteria:
- Healthy, male participants with a body mass index 18 to 30 kg/m2 (inclusive) and a body weight not less than 50 kg
- Must use adequate contraception and not donate sperm during study and for 90 days after receiving the study medication
- Non-smoker and blood pressure between 90 and 140 mmHg systolic, inclusive, and no higher than 90 mmHg diastolic
- Have a 12-lead ECG consistent with normal cardiac conduction and function at screening
Exclusion Criteria:
- Exposure to radiation for professional or medical reasons in the past 12 months
- Recent changes in bowel habits (frequency, consistency, and amount) and irregular defecation pattern (less than one defecation per day)
- History of or current clinically significant medical illness including (but not limited to) cardiac arrhythmias or other cardiac disease, hematologic disease and coagulation disorders
- History of malignancy within 5 years before screening
- Has received a Bacille Calmette-Guérin vaccination within 12 months or any other live bacterial or live viral vaccination within 12 weeks prior to the first administration of study agent
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:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:JNJ-38518168
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Following an at least 10-hour overnight fast, participants will receive a single dose containing 30 mg of 14C JNJ-38518168 given as an oral solution on Day 1
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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 |
|---|---|---|
|
Maximum observed concentration of 14C JNJ-38518168 in plasma
大体时间:Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
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Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
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Time to reach the maximum observed concentration of 14C JNJ-38518168 in plasma
大体时间:Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
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Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
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Area under the concentration-time curve
大体时间:Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
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Predose; and at 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 144, 168, 216, 264, and 336 hours post-dose
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Amount of 14C JNJ-38518168 excreted into the urine during a collection interval
大体时间:Predose and from 0- to 4, 4- to 8, 8- to 12, 12- to 24, 24- to 36, 36- to 48 hours after dosing, and every 24 hours (pooled for 24-hour interval) thereafter until 336 hours post-dose
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Amount excreted into the urine during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the urinary volume with the urinary concentration for that interval.
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Predose and from 0- to 4, 4- to 8, 8- to 12, 12- to 24, 24- to 36, 36- to 48 hours after dosing, and every 24 hours (pooled for 24-hour interval) thereafter until 336 hours post-dose
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Amount of 14C JNJ-38518168 excreted into the feces during a collection interval
大体时间:From Day -1 through Day 14
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Amount excreted into the feces during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the feces weight with the feces concentration for that interval
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From Day -1 through Day 14
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Amount excreted into the vomit during a collection interval (applicable only for participants who experience vomitting)
大体时间:Within 24 hours after dosing
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Amount excreted into the vomit during a collection interval, where t1 and t2 are the start and end times of the collection interval, and calculated by multiplying the weight of the vomit with the vomit concentration for that interval
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Within 24 hours after dosing
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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发生不良事件的参与者人数
大体时间:长达 7 周
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长达 7 周
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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
2012年10月1日
初级完成 (实际的)
2012年12月1日
研究完成 (实际的)
2012年12月1日
研究注册日期
首次提交
2013年10月22日
首先提交符合 QC 标准的
2013年10月22日
首次发布 (估计)
2013年10月25日
研究记录更新
最后更新发布 (估计)
2013年10月25日
上次提交的符合 QC 标准的更新
2013年10月22日
最后验证
2013年10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
- CR100989
- 38518168ARA1004 (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.