NCT05362045已完成1 期
Bioequivalence Study of a Single Dose of 15-mg Mavacamten Capsule Versus a Single Dose of 3 x 5-mg Mavacamten Capsules in Healthy Participants
Bristol-Myers Squibb4 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2022年5月16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
- 158
- 试验地点
- 4
- 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 on the single-dose drug levels of mavacamten in healthy 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
- None
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
- •Body mass index between 18 and 32 kg/m^2, inclusive, at the Screening Visit
- •Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments within the normal range at the screening visit and/or on Day -1
排除标准
- •Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- •History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Mavacamten- Dose A
Experimental
干预措施: Mavacamten (Drug)
Mavacamten- Dose B
Experimental
干预措施: Mavacamten (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to approximately 1 month
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 approximately 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
时间窗: Up to approximately 1 month
次要结局
- Time of maximum observed plasma concentration (Tmax)(Up to approximately 1 month)
- Terminal half-life (T-HALF)(Up to approximately 1 month)
- Number of participants with adverse events (AEs)(Up to approximately 1 month)
- Number of participants with serious adverse events (SAEs)(Up to approximately 1 month)
- Number of participants with vital sign abnormalities exceeding predefined thresholds(Up to approximately 1 month)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to approximately 1 month)
- Number of participants with physical exam abnormalities(Up to approximately 1 month)
- Number of participants with clinical laboratory evaluation abnormalities(Up to approximately 1 month)
研究者
研究点 (4)
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