A Randomized, Double-Blinded, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Pharmacokinetics, and Target Engagement of BMS-986147 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
研究概览
简要总结
This is the first clinical study with the BMS-986147 compound in healthy subjects. The purpose of this study is to guide the dose range and dose frequency for future studies with BMS-986147 and will provide guidelines for selection of a potentially effective dose in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy men and women, ages 18 to 45 years
- •Subjects must not have clinically significant deviation from normal: medical history, physical examination, ECGs and laboratory evaluations
- •Women of child bearing potential are eligible for enrollment.
- •Women must have a negative pregnancy test
排除标准
- •Evidence of organ dysfunction
- •Any significant acute or chronic medical illness
- •Inability to: tolerate oral medications, be venipunctured
研究组 & 干预措施
A1: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
干预措施: BMS-986147 (Drug)
A1: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
干预措施: Placebo matching BMS-986147 (Drug)
A2: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
干预措施: BMS-986147 (Drug)
A2: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
干预措施: Placebo matching BMS-986147 (Drug)
A3: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
干预措施: BMS-986147 (Drug)
A3: BMS-986147 or Placebo matching BMS-986147
Single oral dose as specified
干预措施: Placebo matching BMS-986147 (Drug)
B1: BMS-986147 or Placebo matching BMS-986147
Daily oral dose as specified
干预措施: BMS-986147 (Drug)
B1: BMS-986147 or Placebo matching BMS-986147
Daily oral dose as specified
干预措施: Placebo matching BMS-986147 (Drug)
B2: BMS-986147 or Placebo matching BMS-986147
Daily oral dose as specified
干预措施: BMS-986147 (Drug)
B2: BMS-986147 or Placebo matching BMS-986147
Daily oral dose as specified
干预措施: Placebo matching BMS-986147 (Drug)
结局指标
主要结局
Safety and tolerability of single oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
时间窗: Up to 30 days post last dose of study drug
Adverse event (AE)
Safety and tolerability of multiple oral dose of BMS-986147 based on incidence of AEs, serious AEs, AEs leading to discontinuation, and death as well as marked abnormalities in clinical laboratory tests, vital sign measurements, and physical examinations
时间窗: Up to 30 days post last dose of study drug
次要结局
未报告次要终点