NCT03419910已完成1 期
An Open-Label, Single-Sequence Study to Investigate the Effects of Cyclosporine on the Pharmacokinetics of BMS-986165 at Steady State in Healthy Male Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2018年3月5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
- 54
- 试验地点
- 1
- 主要终点
- Maximum concentration (Cmax)
研究概览
简要总结
This is an investigational study of Cyclosporine on the 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 medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body mass index 18.0 to 32.0 kg/m2
- •Weight ≥ 50 kg
排除标准
- •Any medical condition that presents a potential risk to the subject and/or may compromise the objectives of the study, including a history of or active liver disease
- •History or presence of acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- •Known or suspected autoimmune disorder, or any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the participant's immune status
- •History of administration of live vaccines within 60 days before screening
- •Any history or risk for tuberculosis (TB)
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986165 and cyclosporine
Experimental
BMS-986165 and cyclosporine administered orally
干预措施: BMS-986165 (Drug)
BMS-986165 and cyclosporine
Experimental
BMS-986165 and cyclosporine administered orally
干预措施: Cyclosporine (Drug)
结局指标
主要结局
Maximum concentration (Cmax)
时间窗: 24 hours
Area under the concentration vs time curve from time zero to 24 hours post dose (AUC[0-24])
时间窗: 24 hours
次要结局
- Adverse events (AEs)(Up to 20 days)
研究者
研究点 (1)
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