A Study To Assess The Safety Of PF-05335810 In Hypercholesterolemic Subjects
2018年11月30日 更新者：Pfizer
A Phase I, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Ascending Doses Of PF-05335810 In Hypercholesterolemic Subjects, With One, Open-Label, Multiple Fixed Dosage Cohort
This study is to evaluate the safety, tolerability and immunogenicity of single, ascending or multiple fixed subcutaneous and intravenous administrations of PF 05335810 to hypercholesterolemic subjects when added on to a daily statin dose.
研究概览
地位
完全的
条件
研究类型
介入性
注册 (实际的)
133
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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Connecticut
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New Haven、Connecticut、美国、06511
- Pfizer Investigational Site
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Florida
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Miami、Florida、美国、33169
- Pfizer Investigational Site
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South Miami、Florida、美国、33143
- Pfizer Investigational Site
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Kansas
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Overland Park、Kansas、美国、66212
- Pfizer Investigational Site
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Michigan
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Kalamazoo、Michigan、美国、49007
- Pfizer Investigational Site
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Ohio
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Cincinnati、Ohio、美国、45227
- Pfizer Investigational Site
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Texas
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San Antonio、Texas、美国、78209
- 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
18年 至 70年 (成人、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:
- On stable daily doses of a statin for 45 days prior to receiving study treatment.
- Fasting LDL C equal or greater than 80 mg/dL at screening and visit approximately 1 week prior to randomization.
Exclusion Criteria:
- History of a cardiovascular or cerebrovascular event or procedure within one year of randomization.
- Poorly controlled type 1 or type 2 diabetes mellitus (defined as HbA1c >9%).
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：单组作业
- 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 1
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Single SC Injection
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实验性的：队列 2
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Single Subcutaneous Injection(s)
Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Intravenous Infusion
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实验性的：队列 3
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Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Subcutaneous Injection(s)
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实验性的：队列 4
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Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Intravenous Infusion
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实验性的：队列 5
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Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
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实验性的：队列 6
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Single Subcutaneous Injection(s)
Single Intravenous Infusion
Single Subcutaneous Injection(s)
Single Intravenous Infusion
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
大体时间：Baseline up to Day 85/169 or Early Termination (ET)
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Counts of participants who had treatment-emergent adverse events (TEAEs), defined as newly occurring or worsening after first dose.
Relatedness to [study drug] was assessed by the investigator (Yes/No).
Participants with multiple occurrences of an AE within a category were counted once within the category.
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Baseline up to Day 85/169 or Early Termination (ET)
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Number of Participants With Laboratory Test Values of Potential Clinical Importance
大体时间：Baseline up to Day 85/169 or Early Termination (ET)
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Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
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Baseline up to Day 85/169 or Early Termination (ET)
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Change From Baseline in Heart Rate
大体时间：Baseline, Day 1 to 85/169 or ET
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Baseline, Day 1 to 85/169 or ET
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Diastolic Blood Pressure
大体时间：Baseline, Day 1 to 85/169 or ET
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Baseline, Day 1 to 85/169 or ET
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Change From Baseline in Electrocardiogram (ECG) Parameters
大体时间：Baseline, Day 1 to 85/169 or ET
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Baseline, Day 1 to 85/169 or ET
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Number of Participants With Laboratory Test Values of Potential Clinical Importance
大体时间：Baseline, Day 1 to 85/169 or ET
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Pre-defined criteria were established for each laboratory test to define the values that would be identified as of potential clinical importance.
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Baseline, Day 1 to 85/169 or ET
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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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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
大体时间：Day1 pre-dose to Day 85/169 or ET
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AUC (0 - 8)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - 8).
It is obtained from AUC (0 - t) plus AUC (t - 8).
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Day1 pre-dose to Day 85/169 or ET
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Area Under the Curve From Time Zero to Last Quantifiable Concentration [AUC (0-t)]
大体时间：Day1 pre-dose to Day 85/169 or ET
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AUC (0-t)= Area under the plasma concentration versus time curve from time zero (pre-dose) to time of last quantifiable concentration (0-t)
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Day1 pre-dose to Day 85/169 or ET
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Maximum Observed Plasma Concentration (Cmax)
大体时间：Day1 pre-dose to Day 85/169 or ET
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Day1 pre-dose to Day 85/169 or ET
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
大体时间：Day1 pre-dose to Day 85/169 or ET
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Day1 pre-dose to Day 85/169 or ET
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Apparent Volume of Distribution (Vz/F)
大体时间：Day1 pre-dose to Day 85/169 or ET
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Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug.
Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
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Day1 pre-dose to Day 85/169 or ET
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Apparent Oral Clearance (CL/F)
大体时间：Day1 pre-dose to Day 85/169 or ET
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Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed.
Clearance was estimated from population pharmacokinetic (PK) modeling.
Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
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Day1 pre-dose to Day 85/169 or ET
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Plasma Decay Half-Life (t1/2)
大体时间：Day1 pre-dose to Day 85/169 or ET
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Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
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Day1 pre-dose to Day 85/169 or ET
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Absolute Bioavailability (%F)
大体时间：Day1 pre-dose to Day 85/169 or ET
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Day1 pre-dose to Day 85/169 or ET
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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
2012年7月1日
初级完成 (实际的)
2013年10月1日
研究完成 (实际的)
2013年10月1日
研究注册日期
首次提交
2012年8月3日
首先提交符合 QC 标准的
2012年10月31日
首次发布 (估计)
2012年11月2日
研究记录更新
最后更新发布 (实际的)
2018年12月4日
上次提交的符合 QC 标准的更新
2018年11月30日
最后验证
2018年11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.
PF-05335810 Dose A的临床试验
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Pfizer完全的