An Open-label, Randomized, Single-dose, Three-way Crossover Study to Assess the Relative Bioavailability of 5 mg Mavacamten Opened Capsule Administered Via Nasogastric Tube Compared to 5 mg Mavacamten Intact Capsule in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
研究概览
简要总结
The purpose of this study to assess the relative bioavailability of 5 mg Mavacamten opened capsule administered via nasogastric tube compared to intact oral 5 mg Mavacamten in healthy volunteers.
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
- •Participants must have a body mass index between 18 and 32 kg/m
- •Participants must be healthy, as determined by physical examination, vital signs, ECGs, and clinical laboratory assessments.
- •Participants must be willing and able to adhere to the prohibitions and restrictions specified in the protocol.
排除标准
- •Participants must not have any significant acute or chronic medical illness.
- •Participants must not have any current or recent (within 3 months of study intervention administration) gastrointestinal disease including, but not limited to, bowel obstruction or perforation, gastrointestinal ulcers, esophageal varices, Crohn's disease, diverticulitis, irritable bowel syndrome, ileus, a gastrointestinal tract that is not anatomically intact, dyspepsia, constipation, diarrhea, or vomiting.
- •Participants must not be intolerant or allergic to lidocaine or cetacaine or any type of topical anesthetic.
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Sequence ABC
干预措施: Treatment A: Mavacamten intact oral capsule (Drug)
Sequence ABC
干预措施: Treatment B: Mavacamten open capsule in suspension (Drug)
Sequence ABC
干预措施: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) (Drug)
Sequence BCA
干预措施: Treatment A: Mavacamten intact oral capsule (Drug)
Sequence BCA
干预措施: Treatment B: Mavacamten open capsule in suspension (Drug)
Sequence BCA
干预措施: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) (Drug)
Sequence CAB
干预措施: Treatment A: Mavacamten intact oral capsule (Drug)
Sequence CAB
干预措施: Treatment B: Mavacamten open capsule in suspension (Drug)
Sequence CAB
干预措施: Treatment C: Mavacamten open capsule in suspension administered via nasogastric tube (NGT) (Drug)
结局指标
主要结局
Area under the concentration-time curve from time 0 to the last quantifiable time point (AUC[0-T])
时间窗: Up to 37 days
Area under the concentration-time curve from time 0 to 72 hours (AUC[0-72])
时间窗: Up to 37 days
Area under the concentration-time curve from time 0 to infinite time (AUC[0-INF])
时间窗: Up to 37 days
Maximum observed concentration (Cmax)
时间窗: Up to 37 days
次要结局
- Number of participants with vital sign abnormalities(Up to 37 days)
- Number of participants with electrocardiogram (ECG) findings(Up to 37 days)
- Terminal half-life (T-HALF)(Up to 37 days)
- Apparent clearance (CLT/F)(Up to 37 days)
- Apparent volume of distribution (Vz/F)(Up to 37 days)
- Time of maximum observed plasma concentration (Tmax)(Up to 37 days)
- Number of participants with adverse events (AEs)(Up to 37 days)
- Number of participants with serious adverse events (SAEs)(Up to 37 days)
- Number of participants with physical examination findings(Up to 37 days)
- Number of participants with abnormalities in clinical laboratory evaluations(Up to 37 days)