An Open-label, Randomized, Single-dose, Three-way Crossover Study to Establish Bioequivalence of 5 mg Mavacamten Capsule 1 and 5 × 1 mg Mavacamten Capsule 2 to 5 mg Mavacamten Capsule 2 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 95
- 试验地点
- 3
- 主要终点
- Maximum Observed Serum Concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess 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
- Crossover
- 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 kilograms/meter squared (kg/m^2) inclusive, at the screening visit.
- •Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -
- •Cytochrome P450 (CYP) 2C19 normal, rapid, or ultrarapid metabolizer, as determined by genotyping during screening.
排除标准
- •Any significant acute or chronic medical illness.
- •Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, left ventricular systolic dysfunction, coronary heart disease; current, history, or family history of hypertrophic cardiomyopathy; or evidence of prior myocardial infarction based on ECGs.
- •CYP2C19 poor (*2/*2, *3/*3, or *2/*3) or intermediate (*1/*2, *1/*3, *2/*17) metabolizer, as determined by genotyping during screening.
- •Use of CYP2C19 and CYP3A4 inducers or inhibitors within 28 days of study intervention administration.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Sequence 1
干预措施: Mavacamten Capsule 1 (Drug)
Sequence 1
干预措施: Mavacamten Capsule 2 (Drug)
Sequence 1
干预措施: Mavacamten Capsule 3 (Drug)
Sequence 2
干预措施: Mavacamten Capsule 1 (Drug)
Sequence 2
干预措施: Mavacamten Capsule 2 (Drug)
Sequence 5
干预措施: Mavacamten Capsule 2 (Drug)
Sequence 6
干预措施: Mavacamten Capsule 3 (Drug)
Sequence 2
干预措施: Mavacamten Capsule 3 (Drug)
Sequence 3
干预措施: Mavacamten Capsule 1 (Drug)
Sequence 3
干预措施: Mavacamten Capsule 2 (Drug)
Sequence 3
干预措施: Mavacamten Capsule 3 (Drug)
Sequence 4
干预措施: Mavacamten Capsule 1 (Drug)
Sequence 4
干预措施: Mavacamten Capsule 2 (Drug)
Sequence 4
干预措施: Mavacamten Capsule 3 (Drug)
Sequence 5
干预措施: Mavacamten Capsule 1 (Drug)
Sequence 5
干预措施: Mavacamten Capsule 3 (Drug)
Sequence 6
干预措施: Mavacamten Capsule 1 (Drug)
Sequence 6
干预措施: Mavacamten Capsule 2 (Drug)
结局指标
主要结局
Maximum Observed Serum Concentration (Cmax)
时间窗: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero to Time of Last Quantifiable Concentration [AUC(0-T)]
时间窗: From Day 1 up to Day 35±2 of each period
Area Under the Serum Concentration-time Curve from Time Zero Extrapolated to Infinite Time [AUC(INF)]
时间窗: From Day 1 up to Day 35±2 of each period
次要结局
- Area Under the Serum Concentration-time Curve from Time 0 to 72 Hours [AUC(0-72)](From Day 1 to Day 4 of each period)
- Time of Maximum Observed Serum Concentration (Tmax)(From Day 1 up to Day 35±2 of each period)
- Terminal Half-life (T-HALF)(From Day 1 up to Day 35±2 of each period)
- Number of Participants with Adverse Events (AEs)(Up to 35 days post discontinuation of dosing)
- Number of Participants with Serious Adverse Events (SAEs)(Up to 35 days post discontinuation of dosing)
- Number of Participants with Vital Sign Abnormalities(Up to 35 days post discontinuation of dosing)
- Number of Participants with Electrocardiograms (ECG) Abnormalities(Up to 35 days post discontinuation of dosing)
- Number of Participants with Physical Examination Abnormalities(Up to 35 days post discontinuation of dosing)
- Number of Participants with Clinical Laboratory Evaluation Abnormalities(Up to 35 days post discontinuation of dosing)