NCT05304533已完成1 期
An Open-label, 3-Arm, Parallel Design Pharmacokinetic Interaction Study Between MYK-224 and Cytochrome P450 3A4 Inhibitors Itraconazole and Verapamil in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2022年4月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
研究概览
简要总结
The purpose of this study is to evaluate the effect of co-administration of itraconazole or verapamil on the drug levels of MYK-224 in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Body mass index between 18 and 30 kg/m^2, inclusive
- •Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram and routine laboratory assessments
- •Adequate acoustic windows to enable accurate transthoracic echocardiographic assessment
- •Left Ventricular Ejection Fraction (LVEF) ≥60% at screening and ≥55% prior to MYK-224 dosing
排除标准
- •Any acute or chronic medical illness
- •History of dizziness and/or recurrent headaches
- •History of heart disease
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Arm 1: MYK-224
Experimental
干预措施: MYK-224 (Drug)
Arm 2: MYK-224 + Itraconazole
Experimental
干预措施: MYK-224 (Drug)
Arm 2: MYK-224 + Itraconazole
Experimental
干预措施: Itraconazole (Drug)
Arm 3: MYK-224 + Verapamil
Experimental
干预措施: MYK-224 (Drug)
Arm 3: MYK-224 + Verapamil
Experimental
干预措施: Verapamil (Drug)
结局指标
主要结局
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 36 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
时间窗: Up to 36 days
Maximum observed plasma concentration (Cmax)
时间窗: Up to 36 days
次要结局
- Time of maximum observed plasma concentration (Tmax)(Up to 36 days)
- Number of participants with serious adverse events (SAEs)(Up to 52 days)
- Measurement of left ventricular ejection fraction (LVEF)(Up to 52 days)
- Apparent total body clearance (CLT/F)(Up to 36 days)
- Number of participants with adverse events leading to discontinuation(Up to 52 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 52 days)
- Measurement of left ventricular outflow tract velocity time integral (LVOT-VTI)(Up to 52 days)
- Measurement of left ventricular global longitudinal strain (LV GLS)(Up to 52 days)
- Apparent terminal plasma half-life (T-HALF)(Up to 36 days)
- Number of participants with adverse events (AEs)(Up to 52 days)
- Number of participants with vital sign abnormalities(Up to 52 days)
- Measurement of left ventricular fractional shortening (LVFS)(Up to 52 days)
- Measurement of left ventricle stroke volume (LVSV)(Up to 52 days)
- Number of participants with physical exam abnormalities(Up to 52 days)
- Number of participants with clinical laboratory abnormalities(Up to 52 days)
研究者
研究点 (1)
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