A Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Men
2014年1月9日 更新者:Janssen Research & Development, LLC
A Single-Dose, Open-Label, Randomized, 4-Way Crossover Study to Assess the Effect of Timing of Food Intake on the Pharmacokinetics of Abiraterone Following Single-Dose Administration of Abiraterone Acetate Tablets in Healthy Caucasian and Japanese Male Subjects
The purpose of this study is to evaluate the effect of timing of food intake on systemic abiraterone exposure observed in healthy adult Japanese and Caucasian men.
研究概览
地位
完全的
条件
详细说明
This is a randomized (individuals will be assigned by chance to study treatments), open-label (individuals will know the identity of study treatments), single dose, 4-way crossover study of abiraterone acetate in approximately 48 healthy adult Japanese and Caucasian men.
For the crossover design, the treatment sequences are defined as follows: 1 - ADBC, 2 - BACD, 3 - CBDA, and 4 - DCAB; where Treatment A = abiraterone acetate administered in the fasted state, Treatment B = standardized meal administered 1 hour after abiraterone acetate dose, Treatment C = standardized meal administered 2 hours after abiraterone acetate dose, and Treatment D = standardized meal administered 2 hours before and 2 hours after abiraterone acetate dose.
This study will consist of a screening period followed by four open-label treatment periods separated by a washout period of at least 14 days between dosing.
Eligible participants will be randomly assigned on Day 1 to 1 of 4 treatment sequences that differ with regard to timing of food intake before and/or after dosing with a single dose of 1000 mg of abiraterone acetate.
Serial pharmacokinetic (study of what the body does to a drug) samples will be collected during the open-label treatment phase as detailed in the protocol.
Safety will be monitored throughout the study.
End-of-study assessments will be performed on Day 4 of Period 4 or upon early withdrawal.
研究类型
介入性
注册 (实际的)
51
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
-
-
California
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Cypress、California、美国
-
-
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
25年 至 35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:
- Healthy Caucasian and Japanese male individuals.
- Body mass index between 18 and 30 kg/m2.
- Body weight >=50 kg.
- A normal 12-lead electrocardiogram.
Exclusion Criteria:
- History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results.
- Presence of sexual dysfunction (abnormal libido, erectile dysfunction, etc.) or any medical condition that would affect sexual function.
- History of alcohol consumption of more than 4 drinks daily within 1 year prior to screening and unwillingness to abstain from alcohol-containing food or beverages from within 24 hours before Day-1 through study completion.
- History of, or a reason to believe a participant has a history of drug or alcohol abuse within the past 5 years.
- Positive test for human immunodeficiency virus 1 and 2 antibodies, hepatitis B surface antigen, or hepatitis C antibodies.
- History of smoking or use of nicotine-containing substances within the previous 2 months, as determined by medical history or participant's verbal report.
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: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:治疗B
|
Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
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实验性的:处理C
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Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
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实验性的:处理A
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1000 mg abiraterone acetate administered in the fasting state
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实验性的:处理D
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Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
|
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Changes in mean plasma concentrations of abiraterone
大体时间:Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
Mean plasma concentrations of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
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Maximum plasma concentration of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
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Time to reach the maximum plasma concentration of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
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Area under the plasma concentration-time curve from time 0 to time the last quantifiable concentration of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
|
|
Area under the plasma concentration-time curve from time 0 to infinite time of abiraterone
大体时间:Up to Day 4, treatment period 4
|
Up to Day 4, treatment period 4
|
|
Elimination half-life associated with the terminal slope of the semilogarithmic drug concentration-time curve of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
|
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First-order rate constant associated with the terminal portion of the curve of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
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Time to last quantifiable plasma concentration of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
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Percentage of area under the plasma concentration-time curve from time 0 to infinite time obtained by extrapolation of abiraterone
大体时间:Up to Day 4, treatment period 4
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Up to Day 4, treatment period 4
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The number of participants affected by an adverse event
大体时间:Up to the end of the study (4 days after final dose of study drug) or early withdrawal
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Up to the end of the study (4 days after final dose of study drug) or early withdrawal
|
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。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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1月1日
初级完成 (实际的)
2012年5月1日
研究完成 (实际的)
2012年5月1日
研究注册日期
首次提交
2012年1月19日
首先提交符合 QC 标准的
2012年4月10日
首次发布 (估计)
2012年4月11日
研究记录更新
最后更新发布 (估计)
2014年1月10日
上次提交的符合 QC 标准的更新
2014年1月9日
最后验证
2014年1月1日
更多信息
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.