NCT05350800已完成1 期
A Phase 1, Two-part Study to Evaluate the Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of BMS-986369 and to Explore the Effect of Food the Bioavailability of BMS-986369 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2022年9月12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
- 68
- 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 safety, tolerability, drug levels of BMS-986369 following administration of single ascending oral doses (SAD) in healthy adult participants. The study will also explore the effect of high-fat meal on the single-dose drug level of BMS-986369 in healthy adult 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) 18.0 to 33.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2 for participants
- •Must have a normal or clinically-acceptable 12-lead ECG at screening
- •Absolute neutrophil counts must be greater than 2,500/μL at screening and Day -1
排除标准
- •Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study
- •History of clinically significant endocrine, gastrointestinal (GI), cardiovascular (CV), peripheral vascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary (GU) abnormalities/diseases
- •History of major surgery within 8 weeks before the first dose administration
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
BMS-986369, Part 1 dose escalation
Experimental
干预措施: BMS-986369 (Drug)
BMS-986369 under fasted conditions, Part 2 Food effect
Experimental
干预措施: BMS-986369 (Drug)
BMS-986369 under fed conditions, Part 2 Food effect
Experimental
干预措施: BMS-986369 (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Day 1
Area under the plasma concentration-time curve, from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to 336 hours after dose administration
Time of maximum observed plasma concentration (Tmax)
时间窗: Day 1
次要结局
- Number of participants with Adverse Events (AEs)(From the date of having consented until 30 days after completion of study treatment)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 15)
- Number of participants with clinical laboratory abnormalities(Up to Day 15)
- Number of participants with vital sign abnormalities(Up to Day 15)
- Effect of BMS-986369 on ECG parameters - Part 1(Up to 72 hours)
研究者
研究点 (1)
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