A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of non-serious adverse events (AEs)
研究概览
简要总结
A study to evaluate single and multiple ascending doses of experimental medicine BMS-986318 in healthy participants.
详细描述
A Phase 1, Double-Blind, Placebo-Controlled, Randomized Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986318 Administration in Healthy Participants
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 Participants as determined by no clinically significant deviations from normal in medical history, physical examination, ECG and clinical laboratory results as determined by the investigator
- •Male participants who are sexually active with Women of Child Bearing Potential (WOCBP) must agree to follow instructions for methods of contraception for duration of treatment plus 92 days.
- •Female participants must have documented proof that they are not of childbearing potential and a negative pregnancy test at screening and within 24 hours before the first dose of study treatment.
排除标准
- •Use of any prescription drugs within 4 weeks or use of over-the-counter (OTC) medications or herbal preparations within 2 weeks prior to study treatment administration (except acid controllers, which are not allowed within 4 weeks prior to study treatment administration
- •Women of Child Bearing Potential (WOCBP) or women who are breastfeeding.
- •Any major surgery within 12 weeks of study administration Or any history of GI surgeries as listed.(eg, gastric bypass, gastric banding, Roux-en-Y) or gastric- emptying issues that could impact upon the absorption of nutrients.
研究组 & 干预措施
Monotherapy SAD BMS-986318 or Placebo
Single Ascending Dose (SAD)
干预措施: BMS-986318 (Drug)
Monotherapy SAD BMS-986318 or Placebo
Single Ascending Dose (SAD)
干预措施: Placebo (Other)
Monotherapy MAD BMS-986318 or Placebo
Multiple Ascending Dose (MAD)
干预措施: BMS-986318 (Drug)
Monotherapy MAD BMS-986318 or Placebo
Multiple Ascending Dose (MAD)
干预措施: Placebo (Other)
结局指标
主要结局
Incidence of non-serious adverse events (AEs)
时间窗: up to 30 days
Number of Clinically significant changes in assessment of blood
时间窗: up to 30 days
Incidence of Serious Adverse Events (SAE)
时间窗: up to 30 days
Assessment of respiratory rate
时间窗: up to 30 days
Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities
时间窗: up to 30 days
Number of clinical significant changes in lab assessment of blood serum
时间窗: up to 30 days
Incidence of AEs leading to discontinuation of study treatment
时间窗: up to 30 days
Physical Examination of weight
时间窗: up to 30 days
Physical Examination of BMI
时间窗: up to 30 days
Assessment of body temperature
时间窗: up to 30 days
Physical Examination of height
时间窗: up to 30 days
Assessment of blood pressure
时间窗: up to 30 days
Number of Clinically significant changes in lab assessment of urine
时间窗: up to 30 days
次要结局
未报告次要终点