NCT06577259已完成1 期
A Phase 1, Open-label, Single-site, Randomized, Single-dose, Three-way, Crossover Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations in Healthy Adult Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2024年9月3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
- 25
- 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 assess the relative bioavailability of BMS-986435 tablet formulations in healthy adult male and female 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 weight of ≥ 45 kg and a body mass index (BMI) between 18 and 32 kg/m^2, inclusive.
- •Healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG) and clinical laboratory assessments.
- •Have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality.
排除标准
- •Any acute or chronic medical illness.
- •History of heart disease.
- •Prior exposure to BMS-
- •Other protocol-defined Inclusion/Exclusion criteria apply.
研究组 & 干预措施
Treatment A: BMS-986435 Reference Dose 1
Active Comparator
干预措施: BMS-986435 (Drug)
Treatment B: BMS-986435 Test Dose 1
Experimental
干预措施: BMS-986435 (Drug)
Treatment C: BMS-986435 Test Dose 2
Experimental
干预措施: BMS-986435 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 105 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
时间窗: Up to 105 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
时间窗: Up to 105 days
次要结局
- Area under the plasma concentration-time curve truncated at 72 hour [AUC(0-72h)](Up to 105 days)
- Time of maximum observed concentration [Tmax](Up to 105 days)
- Apparent terminal half-life [T-HALF](Up to 105 days)
- Incidence of adverse events (AEs)(Up to approximately 5 months)
- Incidence of serious adverse events (SAEs)(Up to approximately 5 months)
- Incidence of participants with vital sign abnormalities(Up to 105 days)
- Incidence of participants with physical examinations abnormalities(Up to 105 days)
- Incidence of participants with electrocardiogram (ECG) abnormalities(Up to 105 days)
- Incidence of participants with clinical laboratory abnormalities(Up to 105 days)
研究者
研究点 (1)
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