NCT05320094已完成1 期
An Open-label Study to Evaluate the Effect of Activated Charcoal With Sorbitol on the Pharmacokinetics of Mavacamten 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15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
- 45
- 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 co-administration of activated charcoal with sorbitol 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 30 kg/m^2, inclusive, at the Screening Visit
- •Healthy, as determined by physical examination, vital signs, electrocardiograms (ECGs), and clinical laboratory assessments
排除标准
- •Current or recent (within 3 months of study intervention administration) gastrointestinal disease
- •History of sorbitol or fructose intolerance or inability to tolerate activated charcoal
- •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
Experimental
干预措施: Mavacamten (Drug)
Mavacamten and activated charcoal with sorbitol - Dose A
Experimental
干预措施: Mavacamten (Drug)
Mavacamten and activated charcoal with sorbitol - Dose A
Experimental
干预措施: Activated Charcoal with Sorbitol (Drug)
Mavacamten and activated charcoal with sorbitol - Dose B
Experimental
干预措施: Mavacamten (Drug)
Mavacamten and activated charcoal with sorbitol - Dose B
Experimental
干预措施: Activated Charcoal with Sorbitol (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 1 month
Area under the plasma concentration-time curve from time zero extrapolated to infinite time ((AUC(INF))
时间窗: Up to 2 months
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 2 months
次要结局
- Number of participants with adverse events (AEs)(Up to 3 months)
- Number of participants with serious adverse events (SAEs)(Up to 3 months)
- Time of maximum observed plasma concentration (Tmax)(Up to 1 month)
- Number of participants with vital sign abnormalities exceeding predefined thresholds(Up to 3 months)
- Number of participants with physical exam abnormalities(Up to 3 months)
- Concentration at 24 hours (C24)(Up to 1 month)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 3 Months)
- Number of participants with clinical laboratory evaluation abnormalities(Up to 3 months)
- Apparent terminal plasma half-life (T-HALF)(Up to 2 months)
研究者
研究点 (1)
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