A Pharmacokinetic Study Comparing PF-06439535 And Bevacizumab In Healthy Male Volunteers (REFLECTIONS B739-01)
Phase 1, Double Blind, Randomized, Parallel-Group, Single-Dose, 3-Arm, Comparative Pharmacokinetic Study Of PF-06439535 And Bevacizumab Sourced From US And EU Administered To Healthy Male Volunteers
This study is to prove that the handling (also referred to as pharmacokinetics) of the following drugs PF-06439535, Avastin® (bevacizumab) that is licensed for use in the United States (bevacizumab-US) and Avastin® (bevacizumab) obtained from Europe (bevacizumab-EU) is similar in healthy male volunteers after receiving a single intravenous dose of either drugs.
During the course of the study, the similarity in pharmacokinetics will be assessed by sampling the levels of drug in the blood, and by comparing these levels among the different administration arms of PF-06439535, bevacizumab-US and bevacizumab-EU. Safety, tolerability, and immunologic response to the administered drugs will also be evaluated throughout.
研究概览
研究类型
注册 (实际的)
阶段
- 阶段1
联系人和位置
学习地点
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Florida
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South Miami、Florida、美国、33143
- Pfizer Investigational Site
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Healthy male subjects 21-55 years old
- Subjects who have previously been exposed to a biologic agent (other than a VEGF [Vascular Endothelial Growth Factor Receptor] inhibitor) may enroll provided that at least 3 months have passed since the last administration of that drug
- Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50kg (110lbs)
Exclusion Criteria:
- Evidence or history of a clinically significant disease or clinical finding at Screening
- Previous treatment with an anti-VEGF antibody, or any other antibody or protein targeting the VEGF receptor.
学习计划
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：A = PF-06439535
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
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Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
其他名称：
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有源比较器：B = Bevacizumab-EU
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
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Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
其他名称：
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有源比较器：C = Bevacizumab-US
Intervention Description: Sterile vial 400mg, single-dose 5mg/kg administered as 90-minute infusion on day 1.
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Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
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 |
措施说明 |
大体时间 |
|---|---|---|
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Maximum Observed Plasma Concentration (Cmax)
大体时间：Day 1 - Day 71
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Day 1 - Day 71
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Area Under the Curve from Time Zero to end of dosing interval (AUCtau)
大体时间：Day 1 - Day 71
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Day 1 - Day 71
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Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - 8)]
大体时间：Day 1 - Day 71
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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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Day 1 - Day 71
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Systemic Clearance (CL)
大体时间：Day 1 - Day 71
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Day 1 - Day 71
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Terminal Disposition Half-Life (t1/2)
大体时间：Day 1 - Day 71
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Day 1 - Day 71
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Volume of Distribution at Steady State (Vss)
大体时间：Day 1 - Day 71
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Day 1 - Day 71
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Incidence of anti-bevacizumab antibodies (ADA), including neutralizing antibodies (Nab)
大体时间：Day 1 - Day 71 or LSLV, whichever occurs later
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Day 1 - Day 71 or LSLV, whichever occurs later
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合作者和调查者
赞助
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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