NCT06417229已完成1 期
A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants
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
- Celgene
- 入组人数
- 102
- 试验地点
- 1
- 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 this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
- •Body mass index (BMI) of 18.0 to 32.0 kg/m^2, inclusive.
排除标准
- •Any significant acute or chronic illness.
- •Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
- •History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1: Cohort 8 BMS-986365 Dose 7
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 9 BMS-986365 Dose 8
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 1 BMS-986365 Dose 1
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 2 BMS-986365 Dose 2 Formulation 1
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 2 BMS-986365 Dose 3 Formulation 2
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 3 BMS-986365 Dose 4
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 6 BMS-986365 Dose 5
Experimental
干预措施: BMS-986365 (Drug)
Part 1: Cohort 7 BMS-986365 Dose 6
Experimental
干预措施: BMS-986365 (Drug)
Part 2: Cohort 4 BMS-986365 Dose 9 Fasted
Experimental
干预措施: BMS-986365 (Drug)
Part 2: Cohort 4 BMS-986365 Dose 10 Fed
Experimental
干预措施: BMS-986365 (Drug)
Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365
Experimental
干预措施: BMS-986365 (Drug)
Part 2: Cohort 5 BMS-986365 Dose 11 Fasted Followed by Rabeprazole + Rabeprazole and BMS-986365
Experimental
干预措施: Rabeprazole (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: Up to Day 75
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 75
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 Day 75
次要结局
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 75)
- Number of participants with clinical laboratory abnormalities(Up to Day 75)
- Incidence of serious adverse events (SAE)(Up to Day 75)
- Number of participants with vital sign abnormalities(Up to Day 75)
- To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation(Up to Day 75)
- Number of participants with physical examination abnormalities(Up to Day 75)
- Incidence of adverse events (AE)(Up to Day 75)
研究者
研究点 (1)
Loading locations...
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