NCT03429933已完成1 期
A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study (Including Food Effect, pH Effect, and Japanese Bridging Study) of the Safety, Pharmacokinetics, and Exploratory Pharmacodynamics of Oral BMS-986278 Administration in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2018年2月7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
- 112
- 试验地点
- 1
- 主要终点
- Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
研究概览
简要总结
The purpose of this study is to investigate experimental medication BMS-986278 given to 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
- 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 in good general health in the opinion of the investigator
- •Body mass index (BMI) of 18.0 to 30.0 kg/m2, inclusive, at screening; BMI = weight (kg)/height (m)2
- •Body weight between 55 and 105 kg, inclusive, at screening
- •Female participants must have documented proof that they are not of childbearing potential
- •Participants in the Japanese cohorts must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)
排除标准
- •Women who are of childbearing potential or breastfeeding
- •Any significant acute or chronic medical condition 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
- •History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- •Any major surgery within 6 weeks of study drug administration
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Single Ascending Dose
Experimental
BMS-986278 or placebo
干预措施: BMS-986278 (Drug)
Single Ascending Dose
Experimental
BMS-986278 or placebo
干预措施: Placebo (Other)
Multiple Ascending Dose
Experimental
BMS-986278 or placebo
干预措施: BMS-986278 (Drug)
Multiple Ascending Dose
Experimental
BMS-986278 or placebo
干预措施: Placebo (Other)
结局指标
主要结局
Number of participants experiencing adverse events (AE), serious adverse events (SAE), death, or an AE leading to study discontinuation
时间窗: Up to 30 days
Number of participants with potentially clinically significant changes in ECG parameters, vital signs, clinical laboratory parameters, or physical examinations
时间窗: Up to 30 days
次要结局
未报告次要终点
研究者
研究点 (1)
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