A Double-blind, Placebo-controlled, Randomized, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BMS-986322 in Healthy Participants of Japanese Descent
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of participants with physical examination abnormalities
研究概览
简要总结
The purpose of this study is to assess the safety and tolerability of multiple ascending oral doses of BMS-986322 in healthy participants of Japanese descent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participant must be of Japanese descent (both biological parents are ethnically Japanese).
- •In the opinion of the investigator, is a healthy participant, without any clinically significant abnormalities in their medical history, physical examination, ECGs, or clinical laboratory assessments determinations.
- •Women should be of non-childbearing potential.
排除标准
- •Any significant acute or chronic medical illness.
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug.
- •Any major surgery within 90 days of study drug administration.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Cohort J1
干预措施: BMS-986322 (Drug)
Cohort J1
干预措施: Placebo for BMS-986322 (Other)
Cohort J2
干预措施: BMS-986322 (Drug)
Cohort J2
干预措施: Placebo for BMS-986322 (Other)
Cohort J3
干预措施: BMS-986322 (Drug)
Cohort J3
干预措施: Placebo for BMS-986322 (Other)
结局指标
主要结局
Number of participants with physical examination abnormalities
时间窗: Up to 7 weeks
Number of participants with serious adverse events (SAEs)
时间窗: Up to 7 weeks
Number of participants with adverse events (AEs) leading to discontinuation
时间窗: Up to 7 weeks
Number of deaths
时间窗: Up to 7 weeks
Number of participants with AEs
时间窗: Up to 7 weeks
Number of participants with electrocardiogram (ECG) abnormalities
时间窗: Up to 7 weeks
Number of participants with vital sign abnormalities
时间窗: Up to 7 weeks
Number of participants with clinical laboratory abnormalities
时间窗: Up to 7 weeks
次要结局
- Maximum observed plasma concentration (Cmax)(Day 1 and Day 14)
- Time of maximum observed plasma concentration (Tmax)(Day 1 and Day 14)
- Area under the concentration-time curve within a dosing interval (AUC[TAU])(Day 1 and Day 14)