A Study to Evaluate the Pharmacodynamic Effects of Single Oral Doses of PF-06648671 on β-Amyloid (Aβ) Concentrations in Cerebrospinal Fluid (CSF)
2016年3月21日 更新者：Pfizer
A Phase 1 Investigator-and-subject Blind, Randomized, Placebo Controlled, Parallel Study In Healthy Subjects To Evaluate The Pharmacodynamic Effects Of Single Oral Doses Of Pf-06648671 On Aβ Concentrations In Cerebrospinal Fluid Using Serial Sampling Methodology
This is phase 1 investigator-and-subject blind, sponsor open, randomized, placebo controlled, parallel study in healthy subjects to evaluate the pharmacodynamics effect of single oral doses of PF-06648671 on CSF Aβ concentrations using serial CSF sampling methodology.
研究概览
详细说明
This study is investigator-and-subject blind, sponsor open, randomized, placebo-controlled, parallel study in healthy subjects to evaluate central (CSF) and peripheral (plasma) pharmacodynamics effects (Abeta) over 36 hours post single doses of PF-06648671.
Two cohorts will be run in sequential.
the first cohort is to evaluate the Abeta effect at top dose of 300 mg PF-06648671 and second cohort is to evaluate the Abeta effect at top dose (if more subjects are required) and/or 1-2 lower doses
研究类型
介入性
注册 (实际的)
22
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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California
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Glendale、California、美国、91206
- Glendale Adventist Medical Center
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Glendale、California、美国、91206
- California Clinical Trials Medical Group, 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 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:
- Healthy male and/or female subjects of non childbearing potential
- BMI of 17.5 to 30.5 kg/m2 and a total body weight >50 kg (110 lbs)
- Evidence of a personally signed and dated informed consent document indicating that subject has been informed of all pertinent aspects of the study.
Exclusion Criteria:
- Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated asymptomatic, seasonal allergies at the time of dosing)
- Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer)
- Subjects with a history of significant active bleeding, coagulation disorder or clinically significant finding on prothrombin time/ partial thromboplastin time/International Normalized Ratio (PT/PTT/INR) at Screening
- Subjects with lower spinal malformations (on physical examination), local spinal infection, or other abnormalities that would exclude puncture (LP)
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study
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：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：PF-06648671 High dose group
subjects receive a single oral dose of PF-06648671 at 300 mg
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Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
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实验性的：PF-06648671 Low dose group
Subjects receive a single oral dose of PF-06648671 lower than 300 mg dose
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Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
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安慰剂比较：Placebo group
Subjects receive matching placebo
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Placebo which will be dosed as oral suspension, single doses to match PF-06648671
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实验性的：PF-06648671 Low dose group (2)
Optional arm.
Subjects receive a single oral dose of PF-06648671 at second lower dose if 300 mg dose is not repeated in cohort 2
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Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
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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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CSF Aβ40 and Aβ42 concentration at maximum change from baseline
大体时间：0-36 hours postdose
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0-36 hours postdose
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of participants with AEs and SAEs
大体时间：0-2 weeks
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Counts of participants who have TEAEs, defined as newly occuring or worsening after first dose.
Relatedness to PF-06648671 will be assessed by the investigator (Yes/No).
Participants with multiple occurrence of an AE within a category will be counted once within the category
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0-2 weeks
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supine vital sign
大体时间：0-2 weeks
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Measurement of supine vital signs
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0-2 weeks
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Electrocardiogram (ECG)
大体时间：0-2 weeks
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Measurement of standard 12-lead ECG (single)
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0-2 weeks
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Maximum Observed Plasma Concentration (Cmax)
大体时间：0-72 hours postdose
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0-72 hours postdose
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Area Under the Curve from Time Zero to Last Quantifiable Plasma Concentration (AUClast)
大体时间：0-72 hours postdose
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0-72 hours postdose
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Area Under the Curve From Time Zero to Extrapolated Infinite Time in Plasma (AUCinf)
大体时间：0-72 hours postdose
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0-72 hours postdose
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：0-72 hours postdose
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0-72 hours postdose
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Plasma Decay Half-life (t1/2)
大体时间：0-72 hours postdose
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0-72 hours postdose
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Apparent Oral Clearance (CL/F)
大体时间：0-72 hours postdose
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0-72 hours postdose
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Apparent Volume of Distribution (Vz/F))
大体时间：0-72 hours postdose
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0-72 hours postdose
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Maximum Observed CSF Concentration (CSF Cmax)
大体时间：0-36 hours postdose
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0-36 hours postdose
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Area Under the Curve from Time Zero to Last Quantifiable Concentration in CSF (CSF AUClast)
大体时间：0-36 hours postdose
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0-36 hours postdose
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Area Under the Curve From Time Zero to Extrapolated Infinite Time in CSF (CSF AUCinf)
大体时间：0-36 hours postdose
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0-36 hours postdose
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CSF Decay Half-life (CSF t1/2)
大体时间：0-36 hours postdose
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0-36 hours postdose
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Plasma Aβ40, Aβ42 and Aβtotal
大体时间：0-72 hours postdose
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Plasma Aβ40, Aβ42 and Aβtotal if possible
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0-72 hours postdose
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CSF Aβ37, Aβ38 and Aβtotal Concentration
大体时间：0-36 hours postdose
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0-36 hours postdose
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Number of participants with lab test values of potential clinical importance
大体时间：0-2 weeks
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Pre-defined criteria were established for each lab test to identify potential clinical importance
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0-2 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。
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
2015年10月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2015年3月25日
首先提交符合 QC 标准的
2015年3月30日
首次发布 (估计)
2015年4月2日
研究记录更新
最后更新发布 (估计)
2016年3月22日
上次提交的符合 QC 标准的更新
2016年3月21日
最后验证
2016年3月1日
更多信息
与本研究相关的术语
其他研究编号
- B7991003
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.
PF-06648671的临床试验
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Pfizer终止