Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 1
- 主要终点
- Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.
详细描述
Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)
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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/[height(m)]2
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease
- •Any major surgery within 4 weeks of study drug administration
- •Any gastrointestinal surgery that could impact upon the absorption of study drug
- •Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)
研究组 & 干预措施
Group 1: BMS-986142 or placebo
BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified
干预措施: BMS-986142 (Drug)
Group 1: BMS-986142 or placebo
BMS-986142 or placebo Single dose oral Solution or spray dried dispersion as specified
干预措施: Placebo (Drug)
Group 2: BMS-986142 or placebo
BMS-986142 or placebo Multiple dose oral Solution as specified
干预措施: BMS-986142 (Drug)
Group 2: BMS-986142 or placebo
BMS-986142 or placebo Multiple dose oral Solution as specified
干预措施: Placebo (Drug)
结局指标
主要结局
Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142
时间窗: Single Ascending Dose(SAD) within 8 days
Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142
时间窗: Multiple Ascending Dose (MAD) within 19 days
次要结局
未报告次要终点