A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Doses of BMS-986177 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability, and pharmacokinetics of BMS-986177 in healthy subjects
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 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 30 kg/m2 inclusive. BMI = weight (kg)/ [height (m)]2
- •Females who are not of childbearing potential (i.e., who are post-menopausal or surgically sterile) and men ages 18 to 55, inclusive
排除标准
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population
- •Any condition that could affect drug absorption
- •Other protocol-defined exclusion criteria could apply
研究组 & 干预措施
BMS-986177
BMS-986177 specified dose on specified days
干预措施: BMS-986177 (Drug)
Placebo
Placebo specified dose on specified days
干预措施: Placebo (Other)
结局指标
主要结局
Safety of multiple dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
时间窗: Approximately 16 days
Tolerability of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
时间窗: Approximately 3 days
Safety of single dose of BMS-986177 measured by number of subjects who experience SAEs, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
时间窗: Approximately 3 days
Adverse event (AE), Serious adverse event (SAE)
Tolerability of multiple dose of BMS-986177 measured by number of subjects who experience SAE, deaths, AEs leading to discontinuation, and potential clinically significant changes in ECG parameters, vital signs, laboratory tests and physical examinations
时间窗: Approximately 16 days
次要结局
未报告次要终点