A Phase 1, Open-label, Single-site, Multi-part, Non-randomized, Parallel-group Study to Assess the Relative Bioavailability of BMS-986435 Tablet Formulations (Parts 1 & 2) and Food Effect on the Selected BMS-986435 Tablet Formulations (Part 3) in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
This study is designed to evaluate the relative bioavailability (rBA) of multiple test tablet formulations of BMS-986435 compared to an equal dose of the BMS-986435 reference tablet formulation. The effect of food on the drug levels of selected BMS-986435 tablet formulations will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Participants must have a body weight of ≥ 45 kg and BMI between 18 and 32 kg/m2, inclusive
- •Participants must be healthy as determined by medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), clinical laboratory assessments
- •Participants must have documented left ventricular ejection fraction (LVEF) ≥ 60% and absence of significant cardiac abnormality at screening, as determined by local transthoracic echocardiogram (TTE) assessment
- •Other protocol-defined Inclusion/
排除标准
- 未提供
研究组 & 干预措施
Treatment I
干预措施: BMS-986435 (Drug)
Treatment H
干预措施: BMS-986435 (Drug)
Treatment J
干预措施: BMS-986435 (Drug)
Treatment L
干预措施: BMS-986435 (Drug)
Treatment K
干预措施: BMS-986435 (Drug)
Treatment D
干预措施: BMS-986435 (Drug)
Treatment A
干预措施: BMS-986435 (Drug)
Treatment C
干预措施: BMS-986435 (Drug)
Treatment F
干预措施: BMS-986435 (Drug)
Treatment G
干预措施: BMS-986435 (Drug)
Treatment B
干预措施: BMS-986435 (Drug)
Treatment E
干预措施: BMS-986435 (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to Day 28
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to Day 28
Area under the concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to Day 28
次要结局
- Volume of distribution of terminal phase (Vz/F)(Up to Day 28)
- Number of participants with Adverse Events (AEs)(Up to Day 35)
- Number of participants with Serious AEs (SAEs)(Up to Day 35)
- Number of participants with clinical laboratory abnormalities(Up to Day 28)
- Number of participants with vital sign abnormalities(Up to Day 28)
- Half-life (T-HALF)(Up to Day 28)
- Apparent total body clearance (CLT/F)(Up to Day 28)
- Time of maximum observed concentration (Tmax)(Up to Day 28)
- Number of participants with physical examination abnormalities(Up to Day 28)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 28)
- Area under the plasma concentration-time curve truncated at 72-hour (AUC(0-72h))(Up to Day 28)