NCT05805904已完成1 期
A Double-blind, Placebo-controlled, Randomized, Single and Multiple Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of BMS-986278 in Healthy Chinese Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2023年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Maximum observed concentration (Cmax)
研究概览
简要总结
The purpose of this study is to evaluate the drug levels, safety, and tolerability of BMS-986278 in healthy Chinese 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must be Chinese (both biological parents are ethnically Chinese).
- •Healthy Chinese male and female (women not of child bearing potential) participants as determined by no clinically significant deviation from normal in medical history, physical examination, 12-lead ECGs, or clinical laboratory determinations.
- •Body mass index of 18.0 to 28.0 kg/m2, inclusive. Body mass index = weight (kg)/(height [m])
- •Body weight ≥ 50 kg
排除标准
- •Any significant acute or chronic medical illness that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome
- •Current or recent (within 3 months of study intervention administration) gastrointestinal (GI) disease that could affect the absorption, distribution, metabolism, and excretion of study drug (eg, bariatric procedure, Gilbert's syndrome)
- •Any GI surgery (eg, cholecystectomy and any other GI surgery) that, in the opinion of the investigator, could impact the absorption of study treatment (uncomplicated appendectomy and hernia repair are acceptable)
- •Women who are of childbearing potential
- •Women who are breastfeeding
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, 12-lead ECG, or clinical laboratory determinations beyond what is consistent with the target population. Have abnormal renal function at screening, as evidenced by an estimated glomerular filtration rate < 90 mL/min/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula and the absence of protein in urine
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Group 1
Experimental
干预措施: BMS-986278 (Drug)
Group 1
Experimental
干预措施: Placebo (Drug)
Group 2
Experimental
干预措施: BMS-986278 (Drug)
Group 2
Experimental
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum observed concentration (Cmax)
时间窗: Up to Day 19
Time of maximum observed concentration (Tmax)
时间窗: Up to Day 19
Area under the concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to Day 19
次要结局
- AUC(0-T)(Up to Day 19)
- Number of participants with physical examination abnormalities(Up to Day 19)
- Number of participants with Adverse Events (AEs)(Up to Day 26)
- Number of participants with vital sign abnormalities(Up to Day 19)
- Number of participants with clinical laboratory abnormalities(Up to Day 19)
- Tmax(Up to Day 19)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 19)
- Cmax(Up to Day 19)
研究者
研究点 (1)
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