NCT02480296已完成1 期
A Phase 1, Double-blind, Randomized, Placebo-controlled, Ascending Multiple Oral Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MYK-461 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
- 60
- 试验地点
- 1
- 主要终点
- Safety as measured by the incidence of adverse events
研究概览
简要总结
The purpose of this study is to establish safety, tolerability, pharmacokinetics and pharmacodynamics of multiple doses of MYK-461 in human subjects. This is a randomized, double-blind, placebo-controlled, sequential group, multiple ascending (oral tablet) dose study in healthy volunteers aged 18-55 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Normal body mass index (BMI)
- •Normal LVEF
- •Normal electrocardiogram (ECG)
- •Females must be non pregnant, non lactating and, if sexually active, be using an acceptable birth control method from the time of first dose through 3 months after the last dose of study drug
排除标准
- •Any structural abnormalities on echocardiography
- •Positive results of HIV test and/or seropositive for HCV or HBV
研究组 & 干预措施
MYK-461
Experimental
Oral Tablet x 28 days
干预措施: MYK-461 (Drug)
Placebo
Placebo Comparator
Oral Tablet x 28 days
干预措施: Placebo (Drug)
结局指标
主要结局
Safety as measured by the incidence of adverse events
时间窗: 63 days
Incidence of adverse events
次要结局
- Determination of pharmacokinetic parameters(63 days)
- Characterize pharmacodynamic parameters(63 days)
研究者
研究点 (1)
Loading locations...
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