A Phase I, Double-blind, Double-dummy, Placebo-controlled, Randomised, Four-period Crossover Study to Assess the Effects of Single Oral Doses of ZD4054 (Zibotentan) (10mg and 30mg) on QTc Interval Compared to Placebo, Using AVELOX (Moxifloxacin) as a Positive Control, in Healthy Volunteers Aged 18 to 45 Years.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
研究概览
简要总结
This Study compares two ZD4054 (Zibotentan) doses (10mg and 30mg) with a placebo and a positive control to look at ZD4054 (Zibotentan)'s effect on the ECG of Healthy Volunteer
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, Care Provider, Investigator)
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
- •Non Smoker
- •Normal resting 12-lead ECG with normal QTc interval (<450 msec)
- •Negative screens for serum hepatitis B surface antigen, hepatitis C antibody and Human Immunodeficiency Virus (HIV) at screening
排除标准
- •Receipt of another new chemical entity in the 4 months before dosing in this study; participation in another study and participation in a non-invasive methodology study in which no drugs were given within 30 days before dosing in this study
- •Risk (in the investigator's opinion) of transmitting, through blood or other body fluids, the agents responsible for acquired immune deficiency syndrome (AIDS), hepatitis B or hepatitis C
- •Judgement by the investigator, that the healthy volunteer should not participate in the study
研究组 & 干预措施
3
ZD4054 + ZD4054 placebo + Moxifloxacin placebo
干预措施: ZD4054 Placebo (Drug)
2
ZD4054 placebo + Moxifloxacin
干预措施: ZD4054 (Drug)
2
ZD4054 placebo + Moxifloxacin
干预措施: Moxifloxacin (Drug)
2
ZD4054 placebo + Moxifloxacin
干预措施: ZD4054 Placebo (Drug)
3
ZD4054 + ZD4054 placebo + Moxifloxacin placebo
干预措施: ZD4054 (Drug)
3
ZD4054 + ZD4054 placebo + Moxifloxacin placebo
干预措施: Moxifloxacin placebo (Drug)
1
ZD4054 + Moxifloxacin placebo
干预措施: ZD4054 (Drug)
1
ZD4054 + Moxifloxacin placebo
干预措施: Moxifloxacin placebo (Drug)
4
ZD4054 Placebo + Moxifloxacin placebo
干预措施: ZD4054 (Drug)
4
ZD4054 Placebo + Moxifloxacin placebo
干预措施: ZD4054 Placebo (Drug)
4
ZD4054 Placebo + Moxifloxacin placebo
干预措施: Moxifloxacin placebo (Drug)
结局指标
主要结局
to assess the maximum of the mean changes in time-matched QTcX (study specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo
时间窗: Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h
次要结局
- assess the maximum of mean changes in time-matched QTcX, QT, QTcB, QTcF and QTcI intervals after moxifloxacin administration compared to placebo.(Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h)
- assess the maximum of the mean changes in time-matched QT, QTcB (Bazett's correction), QTcF (Fridericia's correction) and QTcI (subject specific correction) intervals after ZD4054 (Zibotentan) administration (10mg and 30mg) compared to placebo(Pre-dose, 0.5hr, 1h, 2h, 3h, 4h, 6h, 8h, 12h, 24h)
- further assess the safety and tolerability of ZD4054 (Zibotentan) by assessment of adverse events (AEs), laboratory variables and vital signs.(From time of Consent to Last Follow-up Visit)