A Study of Merestinib (LY2801653) in Healthy Participants
2016年8月25日 更新者：Eli Lilly and Company
The Effect of Food on the Bioavailability of Merestinib in Healthy Subjects
The purpose of this study is to evaluate the effect of food on merestinib (standard meal and high-fat meal) compared to the fasted state.
The study will also measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it.
In addition, the tolerability of the study drug will be evaluated.
Information about any side effects that may occur will also be collected.
The study will last approximately 28 days.
Screening is required within 28 days prior to the start of the study.
研究概览
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
-
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Florida
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Daytona Beach、Florida、美国、32117
- Covance Clinical Research Inc
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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 65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:
- Generally healthy sterile male and female participants
- Body mass index (BMI) of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
- Are willing and able to eat the protocol specified high-fat breakfast
Exclusion Criteria:
- Have consumed grapefruits or grapefruit-containing products, Seville oranges or Seville orange juice, star fruit, star fruit juice, or star fruit-containing products, or commercial apple or orange juice within 14 days prior to first dosing
- Regularly use known drugs of abuse and/or show positive findings on urinary drug screening
- Have donated blood of more than 500 milliliters (mL) within the last month
- Cannot stop taking over-the-counter (OTC) or prescription medications that alter gastric pH, at least 14 days prior to first dosing
- Have previously completed or withdrawn from this study or any other study investigating merestinib, and have previously received the investigational product
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：交叉作业
- 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：Merestinib Fasted
Single dose of merestinib administered in fasted state in one of three periods
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口服给药
其他名称：
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实验性的：Merestinib Standard Meal
Single dose of merestinib administered with a standard meal in one of three periods
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口服给药
其他名称：
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实验性的：Merestinib High-Fat Meal
Single dose of merestinib administered with a high-fat meal in one of three periods
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口服给药
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Pharmacokinetics (PK): Maximum Concentration (Cmax) for Merestinib for High-Fat Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
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Predose through 120 hours after administration of study drug
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Pharmacokinetics: Maximum Concentration (Cmax) for Merestinib for Standard Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
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Predose through 120 hours after administration of study drug
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Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for High-Fat Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
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Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under The Concentration Curve AUC(0-∞) for Merestinib for Standard Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Maximum Concentration (Cmax) for Metabolites (M1 and M2) for Standard Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for High-Fat Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
|
Pharmacokinetics: Area Under the Concentration Curve AUC(0-∞) for Metabolites (M1 and M2) for Standard Meal and Fasted State
大体时间：Predose through 120 hours after administration of study drug
|
Predose through 120 hours after administration of study drug
|
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
2016年5月1日
初级完成 (实际的)
2016年8月1日
研究完成 (实际的)
2016年8月1日
研究注册日期
首次提交
2016年5月19日
首先提交符合 QC 标准的
2016年5月19日
首次发布 (估计)
2016年5月20日
研究记录更新
最后更新发布 (估计)
2016年8月29日
上次提交的符合 QC 标准的更新
2016年8月25日
最后验证
2016年8月1日
更多信息
与本研究相关的术语
其他研究编号
- 16439
- I3O-MC-JSBH (其他标识符：Eli Lilly and Company.)
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.