NCT03198013已完成1 期
Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-791826 and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2008年11月11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
- 120
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive
- •Signed informed consent
排除标准
- •Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP)
- •Any significant acute or chronic medical illness
- •History of Gilbert's disease
- •Other protocol inclusion/exclusion criteria may apply
研究组 & 干预措施
Module B
Experimental
Multiple Ascending Dose
干预措施: Placebo (Drug)
Module A
Experimental
Single Ascending Dose
干预措施: Prednisolone (Drug)
Module A
Experimental
Single Ascending Dose
干预措施: BMS-791826 (Drug)
Module A
Experimental
Single Ascending Dose
干预措施: Placebo (Drug)
Module B
Experimental
Multiple Ascending Dose
干预措施: Prednisolone (Drug)
Module B
Experimental
Multiple Ascending Dose
干预措施: BMS-791826 (Drug)
结局指标
主要结局
Incidence of Adverse Events (AEs)
时间窗: Up to 34 days
safety and tolerability
Incidence of serious adverse events (SAEs)
时间窗: Up to 34 days
safety and tolerability
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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