NCT02819271已完成1 期
A First-in-Human Study of the Safety of Single Continuous Intravenous Infusions of CXL-1427 for up to 48 Hours in Healthy Volunteers
Bristol-Myers Squibb0 个研究点目标入组 80 人开始时间: 2014年2月最近更新:
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
- 80
- 主要终点
- Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
研究概览
简要总结
This study is designed to assess a safe dosage of the drug CXL-1427 (BMS-986231) in healthy volunteers.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No evidence of any acute or chronic health disorder
- •Not have taken any prescription medication within 15 days of study entry
- •Not have taken any over-the-counter medication or herbal/vitamin supplement within 3 days of study entry
- •Not have not have any dietary restrictions
- •Have a body mass index (BMI) of ≥18 to ≤34
- •Weigh at least 50kg (110 pounds)
排除标准
- •Be a current or recent (within 6 months of the Screening Visit) smoker or user of any nicotine-containing product
- •Have a history of symptomatic hypotension, orthostatic hypotension or syncope
- •Have a history of headaches or other symptoms attributable to caffeine withdrawal
- •Have a history of any bleeding diathesis
- •Have a positive serology screen for HIV antibody, hepatitis B surface antigen or hepatitis C antibody at screening
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Other)
CXL-1427 (BMS-986231)
Experimental
Experimental
干预措施: CXL-1427 Descending Dose (Drug)
CXL-1427 (BMS-986231)
Experimental
Experimental
干预措施: CXL-1427 Ascending Dose (Drug)
结局指标
主要结局
Safety measured by percentage of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 31 days
Tolerability measured by percentage of Treatment Emergent Adverse Events (TEAEs)
时间窗: Up to 31 days
次要结局
- Steady-state volume of distributions (Vss)(Up to 4 days)
- Time to Css(Up to 4 days)
- Total body clearance (CL)(Up to 4 days)
- Steady-state plasma concentration (Css)(Up to 4 days)
- Area under the plasma concentration (AUC) vs. time curve(Up to 4 days)
- Terminal elimination half-life (1/2)(Up to 4 days)
研究者
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