An Open-label, Single Dose Study to Determine the Metabolism and Elimination of [14C]E2609 in Healthy Male Subjects
2016年1月6日 更新者:Eisai Inc.
This is an open-label, single dose study in healthy male subjects.
研究概览
详细说明
A baseline (predose) fecal sample and a baseline (predose) urine sample will be obtained at the clinic prior to dosing on Day 1.
On Day 1, subjects will begin the Treatment Phase. Subjects will be released from the clinic after at least 10 days since dosing and as soon as the following conditions are met:
- greater than 90% of the administered radioactivity has been recovered, and
- less than 1% of the administered radioactive dose is recovered in two consecutive 24-hour samples each of urine and feces
研究类型
介入性
注册 (实际的)
113
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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Wisconsin
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Madison、Wisconsin、美国、53704
- Covance Clinical Research Unit Inc.
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Madison、Wisconsin、美国、53704
- Covance Laboratories
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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
是的
有资格学习的性别
男性
描述
Inclusion Criteria
Subjects must meet criteria to be included in this study, including but not limited to the following:
- Healthy male 18 - 55 years, inclusive, at the time of informed consent
- Body mass index (BMI) of 18 to 32 kg/m2 at Screening
- Subjects must have had a successful vasectomy (confirmed azoospermia) or they and their female partners not be of childbearing potential or must be practicing highly effective contraception throughout the study period and for 30 days after study drug discontinuation. Sperm donation is not allowed during the study period and for 30 days after study drug discontinuation.
- Provide written informed consent
- Willing and able to comply with all aspects of the protocol
Exclusion Criteria
Subjects who meet any of the following criteria will be excluded from this study:
- Have participated in a 14C-research study within the 6 months prior to Day -2. The total exposure from this and any previous study must be within the recommended levels considered safe.
- Exposure to clinically significant radiation within 12 months prior to Day -2.
- Any laboratory abnormalities considered clinically significant by the investigator, which may require further investigations or treatment
- Clinically significant illness which required medical treatment within 8 weeks or a clinically significant infection within 4 weeks of dosing
- Any history of gastrointestinal surgery (e.g., hepatectomy, nephrotomy, digestive organ resection) that may affect PK profiles of study drugs
- Hypersensitivity to the study drugs or any of their excipients
- Known to be human immunodeficiency virus (HIV) positive
Restrictions will apply on prior and concomitant medications, food and beverages
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 |
|---|---|
|
实验性的:E2609
Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
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Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
|
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 |
|---|---|---|
|
Pharmacokinetics: Elimination of E2609: urine/feces concentration
大体时间:Predose and every 24 hours postdose up to 28 days
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Total radioactivity will be analyzed in urine and feces predose and up to 28 days postdose.
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Predose and every 24 hours postdose up to 28 days
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Pharmacokinetics: Plasma concentration of E2609/metabolite
大体时间:Predose andup to 648 hours postdose
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Total radioactivity will be analyzed in whole blood, plasma, and red blood cells.
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Predose andup to 648 hours postdose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Pharmacokinetics: Metabolic profile of E2609: plasma/urine/feces concentration
大体时间:Predose andup to 648 hours postdose
|
Metabolite profiling in plasma, urine, and feces will be performed by liquid chromatography with radiodetection (radio-high performance liquid chromatography [HPLC]) methods.
A scintillation counter and/or AMS will be used to detect radioactivity.
If needed, plasma and feces samples will be treated with cysteine and/or other reagents before radio-HPLC analyses.
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Predose andup to 648 hours postdose
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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。
赞助
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
2013年6月1日
初级完成 (实际的)
2013年11月1日
研究完成 (实际的)
2014年3月1日
研究注册日期
首次提交
2013年10月29日
首先提交符合 QC 标准的
2013年10月29日
首次发布 (估计)
2013年11月5日
研究记录更新
最后更新发布 (估计)
2016年1月8日
上次提交的符合 QC 标准的更新
2016年1月6日
最后验证
2015年11月1日
更多信息
与本研究相关的术语
其他研究编号
- E2609-A001-005
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.