NCT03660436已完成1 期
An Open-label, Single-sequence Study to Investigate the Effects of BMS-986165 at Steady State on the Single Dose Pharmacokinetics of Mycophenolate Mofetil (MMF) in Healthy Male Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 131 人开始时间: 2018年8月14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
- 131
- 试验地点
- 1
- 主要终点
- Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
研究概览
简要总结
The purpose of this study is to investigate the effects of experimental medication BMS-986165 in healthy male participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy participant, as determined by no clinically significant deviation from normal in physical examination, electrocardiograms (ECGs), and clinical laboratory determinations
- •Body mass index of 18.0 to 32.0 kg/m2, inclusive, and weight ≥ 50 kg, at screening
- •Normal renal function at screening as evidenced by an estimated GFR (glomerular filtration rate) > 80 mL/min/1.732 m2
排除标准
- •Any medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study, including a history of or active liver disease
- •Positive anti- John Cunningham virus (JCV) antibody test at Screening
- •History of allergy to MMF, BMS-986165, related compounds or any significant drug allergy
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986165 + MMF
Experimental
Oral administration
干预措施: BMS-986165 (Drug)
BMS-986165 + MMF
Experimental
Oral administration
干预措施: MMF (Drug)
结局指标
主要结局
Maximum plasma concentration (Cmax) of mycophenolic acid (MPA)
时间窗: 18 days
Area under the concentration vs time curve from time zero to the last quantifiable plasma concentration (AUC[0-T]) of MPA
时间窗: 18 days
AUC extrapolated to infinity (AUC[INF]) of MPA
时间窗: 18 days
次要结局
- Number of adverse events (AE)(Up to 48 days)
- Number of serious adverse events (SAE)(Up to 48 days)
- Number of AEs leading to discontinuation(Up to 48 days)
- Incidence of clinically significant changes in laboratory test results, vital sign measurements, electrocardiograms (ECGs) and physical examination results(18 days)
研究者
研究点 (1)
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