NCT01775761已完成1 期
A Randomized, Placebo- And Positive-Controlled Cross-Over Study To Evaluate The Effect Of Tafamidis On The QTC Interval 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
- 发起方
- Pfizer
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time
研究概览
简要总结
The purpose of this study is to investigate the effects of tafamidis on the intervals of the electrocardiogram, specifically the rate corrected QT interval (QTc) in healthy volunteers.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy, nonsmoking, male and/or female subjects of non-childbearing potential.
- •Body Mass Index (BMI) of 17.5 to 30.5 kg/m
- •Total body weight >50 kg (110 lbs).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease.
- •An ALT or AST measurement >2 times the ULN.
- •12-lead ECG demonstrating QTc >450 msec or a QRS interval >120 msec at Screening.
- •Subjects at increased risk if dosed with moxifloxacin, according to the product label for moxifloxacin.
- •History of risk factors of QT prolongation or torsades de pointes, congenital deafness and family history of sudden death.
研究组 & 干预措施
Period 1: 960 mg tafamidis (Vyndaqel)
Experimental
干预措施: Period 1 (Drug)
Period 2: 400 mg moxifloxacin
Experimental
400 mg moxifloxacin
干预措施: Period 2 (Drug)
Period 3: Placebo
Experimental
干预措施: Period 3 (Drug)
结局指标
主要结局
QTc interval using Fridericia's correction method (QTcF) of tafamidis and placebo (baseline-adjusted) at each post-dose time
时间窗: SCRN, -1, -0.5, 0, 1, 1.5, 2, 3, 4, 6, 12, 24 hrs
次要结局
- QTcF of moxifloxacin and placebo at historical moxifloxacin median Tmax of 3 hours.(Scrn, -1, -0.5, 0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs)
- Tmax(0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs)
- Cmax(0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs)
- AUC0-24(0, 1, .5, 2, 3, 4, 6, 8, 12, 24 hrs)
研究者
研究点 (1)
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