Study of the Effect of Food on the Pharmacokinetics of Mirabegron
2013年6月24日 更新者:Astellas Pharma Inc
A Phase 1, Open-Label, Randomized, Single Oral Dose, Three-Way Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Mirabegron
The purpose of this study is to assess the effect of food on the pharmacokinetics of a single oral dose of mirabegron in healthy male and female subjects.
研究概览
详细说明
Subjects will be assigned in a random order to receive 3 dosing regimens:
- a single oral dose under a fasting condition;
- a single oral dose with food (low fat breakfast);
- a single oral dose with food (high fat breakfast).
研究类型
介入性
注册 (实际的)
76
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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Washington
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Tacoma、Washington、美国、98418
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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
全部
描述
Inclusion Criteria:
- The subject must weigh at least 45 kg and have a body mass index (BMI) between 20.0 and 32.0 kg/m2 , inclusive
- The subject must have a normal or clinically non-significant 12 lead ECG as well as normal or clinically non-significant laboratory test results
- Female subjects must be post-menopausal (defined as at least 2 years without menses), surgically sterile, or practicing effective contraception, and will continue to use effective contraception during the study period. All females must be non-lactating, and must have a negative pregnancy test result
- The subject must have negative test results for drugs of abuse and alcohol screens
- The subject must have good venous access in both arms
Exclusion Criteria:
- The subject has evidence of QTc interval >430 msec for male, >450 msec for female
- The subject has liver function test values (ALT, AST, or bilirubin) above the upper limit of normal
- The subject has a history or presence of psychiatric illness, serious active or recurrent infection, or any medical condition or disorder that precludes the subject from participating in the study
- The subject has a previous history of cancer other than basal cell carcinoma or Stage 1 squamous cell carcinoma that has not been in remission for at least 5 years
- The subject has donated or lost ≥ 450 mL blood within 56 days prior to study drug administration or has donated plasma within 7 days prior to study drug administration
- The subject has received or is anticipated to receive a prescription drug within 14 days prior to Day -1 of Period 1 (within 30 days 1 for any long acting treatments such as depot formulations). Subject has taken any over-the-counter (OTC) medications, including complementary and alternative medicines (except for oral contraceptives and occasional use of acetaminophen of up to 2000 mg/day but not more than 4 days per week) within 14 days
- The subject has consumed alcohol, xanthine derivative-containing food/beverages (tea, chocolate), grapefruit juice, grapefruit-containing products or Seville oranges (e.g., bitter marmalade) within 48 hours before admission into the unit
- The subject has used tobacco-containing products and nicotine-containing products within 6 months
- The subject consumes more than 5 units of alcoholic beverages (one unit is 12 ounces of beer, 4 ounces of wine or 1 ounce of spirits) per week, or has a history of substance abuse, drug addiction, or alcoholism within past 2 years
- The subject is known to have hepatitis or HIV-1 and/or HIV-2, or is positive for hepatitis A antibody IgM, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody
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
- 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 |
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实验性的:1. mirabegron, lower dose
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oral tablet
其他名称:
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实验性的:2. mirabegron, higher dose
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oral tablet
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
Assess the effects of food on the pharmacokinetics of a single oral dose of mirabegron
大体时间:4-5 weeks
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4-5 weeks
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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。
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。
有用的网址
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
2009年5月1日
初级完成 (实际的)
2009年7月1日
研究完成 (实际的)
2009年7月1日
研究注册日期
首次提交
2009年7月13日
首先提交符合 QC 标准的
2009年7月14日
首次发布 (估计)
2009年7月15日
研究记录更新
最后更新发布 (估计)
2013年6月26日
上次提交的符合 QC 标准的更新
2013年6月24日
最后验证
2013年6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.
mirabegron的临床试验
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Genuine Research Center, EgyptHikma Pharma完全的
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Aaron CypessNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National Institutes...完全的
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Chang Gung Memorial Hospital完全的
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Women and Infants Hospital of Rhode IslandPatient-Centered Outcomes Research Institute; University of California, San Diego; University... 和其他合作者招聘中