A Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-986322 in Healthy Participants Including an Open-label Assessment of Food and pH Effects on Relative Bioavailability of BMS-986322
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Vital signs of blood pressure
研究概览
简要总结
A Study assessing the drug levels and drug effects of variable doses of BMS-986322 in Healthy Participants compared to a placebo. The study also assesses how BMS-986322 affects the body with food and its acidity levels.
详细描述
Recruitment temporarily on hold due to COVID-19.
This is a randomized, double-blind, placebo-controlled study which will investigate the safety, tolerability, and PK of single and multiple oral doses of BMS-986322 in healthy subjects. The trial consists of three parts: Part A - a single ascending dose (SAD) safety and pharmacokinetic (PK) evaluation; Part B -a multiple ascending dose (MAD) safety, PK, and pharmacodynamic (PD) evaluation; and Part C - effect of food and pH on PK and safety.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Healthy Participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body mass index (BMI) of 18.0 kg/m^2 to 32.0 kg/m^2, inclusive, and body weight ≥ 50 kg, at screening
- •Women and men must agree to follow methods of contraception.
排除标准
- •Any significant acute or chronic medical illness
- •History of recent infection
- •History of allergy to BMS-986322 or other compounds
- •Other protocol-defined inclusion/exclusion criteria could apply.
研究组 & 干预措施
Part A: BMS-986322
干预措施: BMS-986322 (Drug)
Part A: BMS-986322
干预措施: BMS-986322 Placebo (Other)
Part B: BMS-986322 Placebo
干预措施: BMS-986322 (Drug)
Part B: BMS-986322 Placebo
干预措施: BMS-986322 Placebo (Other)
Part C: BMS-986322 with famotidine
干预措施: BMS-986322 (Drug)
Part C: BMS-986322 with famotidine
干预措施: famotidine (Drug)
结局指标
主要结局
Vital signs of blood pressure
时间窗: up to 12 months
Incidence of Serious Adverse Events (SAEs)
时间窗: up to 12 months
Vital signs of body temperature
时间窗: up to 12 months
Number of clinically significant changes in lab assessment of urine
时间窗: up to 12 months
Terminal elimination half-life (T-Half) of BMS-986322 in Part C
时间窗: up to 12 months
Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration [AUC(0-T)] of BMS-986322 in Part C
时间窗: up to 12 months
Incidence of Death
时间窗: up to 12 months
Number of clinically significant changes in Electrocardiograms (ECGs)
时间窗: up to 12 months
Area under the plasma concentration-time curve extrapolated to infinity [AUC(INF)] of BMS-986322 in Part C
时间窗: up to 12 months
Incidence of Adverse Effects (AEs)
时间窗: up to 12 months
Incidence of Adverse Events leading to discontinuation
时间窗: up to 12 months
Number of clinically significant changes in lab assessment of blood serum
时间窗: up to 12 months
Number of Clinically significant changes in lab assessment of blood
时间窗: up to 12 months
Maximum concentration (Cmax) of BMS-986322 in Part C
时间窗: up to 12 months
Terminal elimination rate constant (Lambda_z) of BMS-986322 in Part C
时间窗: up to 12 months
Apparent volume of distrubution at terminal phase (Vz/F) of BMS-986322 in Part C
时间窗: up to 12 months
Vital signs of respiratory rate
时间窗: up to 12 months
Number of Participants with abnormal physical examinations
时间窗: up to 12 months
Time of maximum concentration (Tmax) of BMS-986322 in Part C
时间窗: up to 12 months
Apparent oral clearance (CL/F) of BMS-986322 in Part C
时间窗: up to 12 months
次要结局
未报告次要终点