AZD3293 Thorough QT Study in Healthy Male Volunteers (AZD3293TQT)
2014年7月2日 更新者：AstraZeneca
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (Moxifloxacin) as a Positive Control, in Healthy Male Subjects
A thorough QT study of AZD3293
研究概览
详细说明
A Single-Center, Randomized, Double-Blinded, Placebo-Controlled, 4-way Cross-over Study to Assess the Effect of a Single Oral Dose of AZD3293 Administration on QTc Interval Compared to Placebo, Using Open-Label AVELOX (moxifloxacin) as a Positive Control, in Healthy Male Subjects
研究类型
介入性
注册 (实际的)
52
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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Maryland
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Baltimore、Maryland、美国
- Research 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 55年 (成人)
接受健康志愿者
是的
有资格学习的性别
男性
描述
Inclusion Criteria:
- Provision of signed, written and dated informed consent prior to any study-specific procedures
- Healthy male subjects must be able to understand and be willing to comply with study procedures, restrictions and requirements
- Healthy male subjects aged 18 to 55 years
- Body weight ≥ 50 to ≤ 100 kg and body mass index (BMI) ≥19 to ≤30
- Clinically normal findings on physical examination in relation to age, as judged by the investigator.
Exclusion Criteria:
- History of any clinically significant disease or disorder which may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study
- History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder
- History of neurologic disease, including seizures (with the exception of febrile infantile seizures), recent memory impairment or clinically significant head injury
- History of psychotic disorder among first degree relatives
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：交叉作业
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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安慰剂比较：安慰剂
安慰剂口服液
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Placebo oral solution - one single dose
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实验性的：AZD3293 dose A
AZD3293 therapeutic dose oral solution (low dose)
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AZD3293 oral solution - one single dose (low dose).
其他名称：
AZD3293 oral solution - one single dose (high dose).
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|
实验性的：AZD3293 dose B
AZD3293 supratherapeutic dose oral solution (high dose)
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AZD3293 oral solution - one single dose (low dose).
其他名称：
AZD3293 oral solution - one single dose (high dose).
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有源比较器：莫西沙星
莫西沙星片
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Moxifloxacin tablet - one single dose
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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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The effect of a single dose of AZD3293 low dose and high dose on the change in time-matched QTcF intervals compared with placebo.
大体时间：Up to 69 days
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The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
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Up to 69 days
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The effect of a single oral dose of moxifloxacin on the changes in time-matched QTcF intervals compared with placebo.
大体时间：Up to 69 days
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The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula.
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Up to 69 days
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The safety and tolerability of AZD3293 in healthy male subjects by assessing a panel of adverse events measures
大体时间：Up to 69 days
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Physical examination, electrocardiogram, pulse and blood pressure, weight and laboratory variables
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Up to 69 days
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Plasma concentrations, AUC, Cmax and tmax of single dose AZD3293 and moxifloxacin in healthy male subjects
大体时间：Up to 69 days
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AUC(0-t): Area under the concentration versus time curve from time 0 to the time of the last quantifiable concentration to be calculated by a combination of linear and logarithmic trapezoidal methods (linear up-log down) Cmax: Maximum observed plasma concentration obtained directly from the concentration vs. time data tmax: Time to reach Cmax following dose, obtained directly from the concentration vs. time data
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Up to 69 days
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The effect of AZD3293 on additional electrocardiogram (ECG) variables (heart rate, RR, PR, QRS, QT and QTcB)
大体时间：Up to 69 days
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RR: The time between corresponding points on 2 consecutive R waves on ECG.
PR: ECG interval measured from the onset of the P wave to the onset of the QRS complex.
QRS: ECG interval measured from the onset of the QRS complex to the J point.
QT: ECG interval measured from the onset of the QRS complex to the offset of the T wave.
QTcB: The heart rate corrected QT calculated using Bazett's formula.
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Up to 69 days
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The relationship between plasma concentrations of AZD3293 and changes in QTcF parameters
大体时间：Up to 69 days
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The heart rate corrected QT (QTcF) will be calculated using Fridericia's formula
|
Up to 69 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。
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
2014年1月1日
初级完成 (实际的)
2014年5月1日
研究完成 (实际的)
2014年5月1日
研究注册日期
首次提交
2014年1月17日
首先提交符合 QC 标准的
2014年1月17日
首次发布 (估计)
2014年1月20日
研究记录更新
最后更新发布 (估计)
2014年7月3日
上次提交的符合 QC 标准的更新
2014年7月2日
最后验证
2014年7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.