A Double-Blind, Randomised, Multicentre, Placebo-Controlled, 4-Ways Crossover Study to Investigate the Effect on the QT/QTc Interval of Repeated and Escalating Doses of AZD3480 During 6 Days, Using Moxifloxacin as a Positive Control, in Healthy Male Volunteers, CYP2D6 Extensive and Poor Metabolisers.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 75
- 主要终点
- QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
研究概览
简要总结
The purpose of this study is to evaluate the effects on cardiac repolarisation of supratherapeutic doses of AZD3480 compared to placebo in healthy male volunteers, subgrouped as extensive metabolisers and poor metabolisers according to CYP2D6 metabolic capacity, using moxifloxacin as positive control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participation in a previous study for genotyping for identification to be extensive or poor metaboliser (CYP2D6 enzyme)
- •Physically and mentally healthy male volunteers
排除标准
- •History of clinically significant diseases or illness.
- •Participation in another study the last 3 months
- •Prescribed or non-prescribed medications from 3 weeks prior to first treatment day until follow-up except for paracetamol (max 1.5 g per day.)
研究组 & 干预措施
1
Escalating doses of AZD3480 during 6 days
干预措施: AZD3480 (Drug)
2
Repeated doses of AZD3480 during 6 days
干预措施: AZD3480 (Drug)
3
Placebo during 6 days
干预措施: PLACEBO (Drug)
4
Placebo during 5 days, active day 6
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
QTcX interval (supratherapeutic doses in comparison to placebo).Subject-specific correction of QT, QTcF and QTcB (supportive outcome variables).Bazett QTcB=QT*RR-1/2Fridericia QTcF=QT'RR-1/3
时间窗: 11 dECG measurements x 4 (4-way crossover)
次要结局
- QTcX (therapeutic doses in comparison to placebo).PR-, QRS-, RR-intervals(11 dECG measurements x 4 (4-way crossover))
- Plasma concentration (AUC, Cmax, tmax etc)(11 PK-measurements x 4 (4-way crossover))
- Registration of AEs, blood pressure, ECG, clinical laboratory tests(From enrolment to follow-up)