NCT05405543已完成1 期
A Phase 1 Evaluation of the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of MYK-224 in Healthy Adult Japanese Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年7月12日最近更新:
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
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the effects of both single and multiple dose drug levels of MYK-224 in healthy adult Japanese participants.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy as determined by medical history, physical examination, vital signs,12-lead electrocardiogram and routine laboratory assessments
- •Must have documented left Ventricular Ejection Fraction (LVEF) ≥60% (2D biplane Simpson's Method) at screening as determined by the echocardiographic core laboratory.
排除标准
- •Any acute or chronic medical illness
- •History of heart disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm 2
Experimental
干预措施: Placebo (Other)
Arm 3
Experimental
干预措施: MYK-224 (Drug)
Arm 3
Experimental
干预措施: Placebo (Other)
Arm 4
Experimental
干预措施: MYK-224 (Drug)
Arm 1
Experimental
干预措施: MYK-224 (Drug)
Arm 1
Experimental
干预措施: Placebo (Other)
Arm 2
Experimental
干预措施: MYK-224 (Drug)
Arm 4
Experimental
干预措施: Placebo (Other)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 72 days
Time of maximum observed concentration (Tmax)
时间窗: Up to 72 days
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
时间窗: Up to 72 days
次要结局
- Number of participants with serious adverse events (SAEs)(Up to 130 days)
- Number of participants with adverse events leading to discontinuation(Up to 130 days)
- Number of participants with vital sign abnormalities(Up to 72 days)
- Number of participants with physical exam abnormalities(Up to 72 days)
- Number of participants with clinical laboratory abnormalities(Up to 72 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 72 days)
- Measurement of left ventricular ejection fraction (LVEF)(Up to 72 days)
- Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)(Up to 72 days)
- Measurement of left ventricular fractional shortening (LVFS)(Up to 72 days)
- Relative bioavailability of test formulation compared to the reference formulation based on Cmax(Up to 72 days)
- Relative bioavailability of test formulation compared to the reference formulation based on AUC(0-T)(Up to 72 days)
- Relative bioavailability of test forumulation compared to the reference formulation based on area under the concentration-time curve from time zero extrapolated to infinite time AUC(INF)(Up to 72 days)
- Number of participants with adverse events (AEs)(Up to 130 days)
- Measurement of left ventricular global longitudinal strain (LV GLS)(Up to 72 days)
- Measurement of left ventricle stroke volume (LVSV)(Up to 72 days)
- Measurement of lateral and septal early diastolic mitral annular velocity (e')(Up to 72 days)
- Measurement of early diastolic mitral inflow velocity to early diastolic mitral annular velocity (E/e')(Up to 72 days)
- Measurement of early diastolic mitral inflow velocity to late diastolic mitral inflow velocity ratio (E/A ratio)(Up to 72 days)
- Measurement of left ventricular (LV) mass index(Up to 72 days)
- Measurement of left atrial volume index(Up to 72 days)
- Measurement of interventricular septal thickness(Up to 72 days)
- Measurement of posterior wall thickness(Up to 72 days)
- Measurement of LV end diastolic volume(Up to 72 days)
- Measurement of LV end diastolic volume index(Up to 72 days)
- Measurement of LV end systolic volume(Up to 72 days)
- Measurement of LV end systolic volume index(Up to 72 days)
研究者
研究点 (1)
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