NCT05719805已完成1 期
An Open-label, Randomized, Single-dose, 2-way Crossover Study to Establish Bioequivalence of 1 × 15-mg Mavacamten Capsule to 3 × 5-mg Mavacamten Capsules in Healthy Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年2月20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
- 84
- 试验地点
- 2
- 主要终点
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
研究概览
简要总结
The purpose of the study is to evaluate the effect between two different single doses of mavamten 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 kg/m^2, inclusive, at the screening visit.
- •Healthy, as determined by physical examination, vital signs, 12-lead ECGs, and clinical laboratory assessments (including hematology, chemistry, and urinalysis) within the normal range at the screening visit and/or on Day -
- •Participants with values outside of the normal range may be included if the values are not considered, by the investigator, to be clinically significant unless such values are explicitly excluded.
- •Cytochrome P450 (CYP2C19) normal (*1/*1), rapid (*1/*17), or ultra-rapid (*17/*17) metabolizer, as determined by genotyping during screening.
排除标准
- •Current or history of clinically significant cardiac condition, including but not limited to arrhythmia, LV systolic dysfunction, coronary heart disease; current, history, or family history of HCM; or evidence of prior myocardial infarction based on ECGs.
- •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.
- •Any gastrointestinal surgery (other than appendectomy) that, in the opinion of the investigator, could impact the absorption of study intervention.
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Mavacamten Dose 1
Experimental
干预措施: Mavacamten (Drug)
Mavacamten Dose 2
Experimental
干预措施: Mavacamten (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC [INF])
时间窗: Predose and post-dose up to Day 80
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
时间窗: Predose and post-dose up to Day 80
Maximum observed plasma concentration (Cmax)
时间窗: Predose and post-dose up to Day 80
次要结局
- Number of Participants with Serious AEs (SAEs)(Up to Day 80)
- Number of Participants with Vital Sign Abnormalities(Up to Day 80)
- Number of Participants with Adverse Events (AEs)(Up to Day 80)
- Time of maximum observed plasma concentration (Tmax)(Predose and post-dose up to Day 80)
- Number of Participants with Physical Examination Abnormalities(Up to Day 80)
- Number of Participants with Electrocardiogram (ECG) Abnormalities(Up to Day 80)
- Terminal Half-life (T-Half)(Predose and post-dose up to Day 80)
- Number of Participants with Clinical Laboratory Abnormalities(Up to Day 80)
研究者
研究点 (2)
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