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
概览
- 阶段
- 1 期
- 干预措施
- MYK-461
- 疾病 / 适应症
- Healthy
- 发起方
- MyoKardia, Inc.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Safety as measured by the incidence of adverse events
- 状态
- 已完成
- 最后更新
- 9年前
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.
研究者
入排标准
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
Oral Tablet x 28 days
干预措施: MYK-461
Placebo
Oral Tablet x 28 days
干预措施: Placebo
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)
研究点 (1)
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