A Single-centre, Double-blind, Double-dummy, Randomised, Placebo-controlled, Four-period Crossover Study to Assess the Effect of Single Oral Doses of AZD5672 (600 mg and 150 mg) on QT/QTc Interval, Compared to Placebo, Using Moxifloxacin (Avelox®) as a Positive Control, in Healthy Male Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
研究概览
简要总结
This study is being performed to investigate the potential for AZD5672 to affect the electrical conduction pathways in the heart. AZD5672 will be compared against a drug (moxifloxacin - a licensed antibiotic) known to have a detectable but safe change on the electrical conduction of the heart.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) between 18 and 30 kg/m2 and a minimum weight of 50kg.
- •Non-smoker
排除标准
- •Marked QTc prolongation at baseline e.g. repeated demonstration of QTc interval >450ms or marked shortening of QTcF <350ms
- •Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of the QTc Interval changes
- •Use of concomitant medications that prolong QT/QTc interval
研究组 & 干预措施
A
600mg AZD5672 + Moxifloxacin placebo
干预措施: AZD5672 (Drug)
A
600mg AZD5672 + Moxifloxacin placebo
干预措施: placebo (Drug)
B
100mg AZD5672 + Moxifloxacin placebo
干预措施: AZD5672 (Drug)
B
100mg AZD5672 + Moxifloxacin placebo
干预措施: placebo (Drug)
C
AZD5672 placebo + Moxifloxacin 400mg
干预措施: Moxifloxacin (Drug)
C
AZD5672 placebo + Moxifloxacin 400mg
干预措施: placebo (Drug)
D
AZD5672 placebo + Moxifloxacin placebo
干预措施: placebo (Drug)
结局指标
主要结局
Evaluate time-matched QTcF intervals of single dose AZD5672 600mg compared to placebo.
时间窗: Up to 24 hours postdose
次要结局
- Evaluate time-matched QTcF Intervals of single dose AZD5672 150mg compared to placebo.(Up to 24 hours postdose)
- To evaluate the change in time matched ECG parameters (QTcB, QTcX, RR, PR and QRS) of single dose AZD5672 600mg and 150mg compared to placebo(Up to 24 hours postdose)
- To further evaluate the safety and tolerability of single dose AZD5672 600mg and 150mg(Adverse events assessed throughout the whole study. Safety monitoring (BP, safety blood samples and ECG) conducted frequently throughout study and up to 72 hours post dose on treatment visits.)