NCT01790087已完成1 期
A Four Period, Four-Arm, Crossover Design, Randomized, Placebo and Active Controlled Study for the Evaluation of the Effect of Therapeutic and Supratherapeutic Single-Dose ANX-188 on the QT/QTc Intervals in Healthy Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)
研究概览
简要总结
This study has been designed in compliance with the ICH-E14 guideline (2005) to evaluate the effect of ANX-188 at therapeutic and supratherapeutic concentrations on cardiac repolarization, specifically, Fridericia's QT-Interval (QTcF)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects aged 18 to 65 (inclusive) in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory testing at screening.
排除标准
- •Participation in a clinical trial within the last 60 days
- •Pregnant or lactating females
- •Use of prescription drugs, herbals, or over-the-counter medications within 14 days prior to study day -2
- •Uncontrolled cardiac arrhythmias, cardiac valve abnormalities, or not in normal sinus rhythm
- •Smokers or tobacco product user in the prior 3 months
- •Presence of clinically significant illness
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
ANX-188 Therapeutic dose level
Experimental
IV administration. 100 mg/kg for one hour followed by 30 mg/kg/hour for five hours
干预措施: ANX-188 Therapeutic Dose (Drug)
ANX-188 Supratherapeutic dose
Experimental
IV administration. 300 mg/kg for one hour followed by 200 mg/kg/hr for five hours
干预措施: ANX-188 Supratherapeutic dose (Drug)
Saline
Placebo Comparator
IV administration. Six hour infusion.
干预措施: Saline (Drug)
Moxifloxacin
Active Comparator
Oral tablet. 400 mg.
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Evaluate the effect of therapeutic and supratherapeutic doses of ANX-188 on cardiac ventricular repolarization, specifically, the Fridericia's corrected QT-Interval (QTcF)
时间窗: Day 1 Pre-dose to 24 hours post-dose
次要结局
- PR interval measurements on treatment compared to time-matched baseline and placebo(Pre-dose to 24 hours post-dose)
- Overall characterization of normal and abnormal ECGs and the number and percentage of subjects with normal and abnormal ECGs(Pre-dose to 24 hours post-dose)
- Number and percentage of subjects that develop abnormalities of repolarization on treatment(Pre-dose to 24 hours post-dose)
- Number and percentage of subjects the develop abnormal U waves(Pre-dose to 24 hours post-dose)
- Relationship between changes from the baseline and placebo in QTcF (DDQTcF)(Pre-dose to 24 hours post-dose)
- Bazett's corrected QT-interval (QTcB)(Pre-dose to 24 hours post-dose)
- Heart rate measurements on treatment compared to time-matched baseline and placebo(Pre-dose to 24 hours post-dose)
- RR-interval on treatment compared to time-matched baseline and placebo(Pre-dose to 24 hours post-dose)
- QRS measurements on treatment compared to time-matched baseline and placebo(Pre-dose to 24 hours post-dose)
- Analysis for arrhythmias(Pre-dose to 24 hours post-dsoe)
- Correlation of ECG findings with clinical adverse events(Pre-dose to 24 hours post-dose)
研究者
研究点 (1)
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