A Study to Evaluate Safety, Tolerability, Plasma Drug Levels, and Cognitive Response Following Multiple Doses of a Drug in Healthy Elderly Participants.
2009年6月9日 更新者：Pfizer
An Investigator And Subject-Blind Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 Up To An Exposure Cap In Healthy Elderly Subjects
Evaluate the safety and tolerability of PF-04447943 after administration of multiple doses in healthy elderly participants.
Evaluate plasma drug levels and effects on cognition.
研究概览
研究类型
介入性
注册 (实际的)
32
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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Gainesville、Florida、美国、32608
- Pfizer Investigational Site
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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
65年 至 85年 (年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Healthy male and/or female subjects.
- Subjects must be in reasonably good health as determined by the investigator based on medical history, full physical examination (including blood pressure and pulse rate measurement), 12 lead ECG and clinical laboratory tests.
- Subjects with mild, chronic, stable disease (eg, controlled hypertension, non-insulin dependent diabetes, osteoarthritis may be enrolled if deemed medically prudent by the investigator.
- Subjects taking daily prescription or non-prescription medications for management of acceptable chronic medical conditions must be on a stable dose.
- Body Mass Index (BMI) between 18 to 30 kg/m2, inclusive; and a total body weight >50 kg (110 lbs).
- Creatinine clearance greater than 30 mL/min using the Cockcroft-Gault method.
Exclusion Criteria:
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, immunologic, or allergic disease.
- Use of tobacco or any form of nicotine in the past 6 months.
- Greater than 7 drinks of alcohol per week for women, and greater than 14 drinks of alcohol per week for men.
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：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：队列 4
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Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days.
Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days.
Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
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实验性的：Cohort 1
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
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Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days.
Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days.
Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
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实验性的：Cohort 2
Subjects will be randomized to receive either experimental drug (n=6) or placebo (n=2).
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Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days.
Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days.
Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
|
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实验性的：Cohort 3a
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
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Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days.
Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days.
Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
|
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实验性的：Cohort 3b
Subjects will be randomized to receive either experimental drug (n=3) or placebo (n=1).
|
Planned oral dose is PF-04447943, 5 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 15 mg q12 hours for 7 days.
Planned oral dose is PF-04447943, 35 mg q12 hours for 7 days.
Actual dose may be adjusted based on pharmacokinetic and other data from prior dose cohorts.
Planned oral dose is PF-04447943, 35 mg q12 hours for 14 days.
Actual dose may be adjusted downward based on pharmacokinetic and other data from prior dose cohorts.
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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 |
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Safety endpoints include evaluation of adverse events, change from baseline in vital signs, triplicate and single ECGs, and clinical safety laboratory tests
大体时间：For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
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For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
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Pharmacokinetic endpoints include plasma PF-04447943 area udner the curve (AUCt ), maximum plasma concentration (Cmax) and time of maximum plasma concentration (Tmax)
大体时间：For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14
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For cohorts 1-3, days 1 and 7; for cohort 4, days 1 and 14
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Maximum plasma concentration (Cmax)
大体时间：1 hour post dose day 4
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1 hour post dose day 4
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Minimum plasma concentration ((Ctrough)
大体时间：For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13
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For cohorts 1-3, days 2, 3, 4, and 7; for cohort 4, days 2, 3, 4, 12, and 13
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Fraction of the total dose excreted in urine (Fe) and the renal clearance (CLR), and, if the data permit, half-life and the observed exposure accumulation ratio (Ro), and fluctuation index (Cmax: Cmin ratio) following multiple doses
大体时间：For cohorts 1-3, day 7; for cohort 4, day 14
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For cohorts 1-3, day 7; for cohort 4, day 14
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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CogState Phase 1 Battery, to include Detect, Identify, One-Card Learning, Groton Maza Learning, Continuous Paired Associated Learning Test, and Composite Cognitive Score
大体时间：For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
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For cohorts 1-3, up to 17 days; for cohort 4, up to 24 days.
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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
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
2009年1月1日
初级完成 (实际的)
2009年5月1日
研究完成 (实际的)
2009年5月1日
研究注册日期
首次提交
2009年1月27日
首先提交符合 QC 标准的
2009年1月27日
首次发布 (估计)
2009年1月29日
研究记录更新
最后更新发布 (估计)
2009年6月12日
上次提交的符合 QC 标准的更新
2009年6月9日
最后验证
2009年6月1日
更多信息
与本研究相关的术语
其他研究编号
- B0401009
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.