NCT03739788已完成1 期
Study to Evaluate the Absolute Bioavailability of BMS-986165 Tablet in Healthy Male Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2018年12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
- 8
- 试验地点
- 1
- 主要终点
- Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data
研究概览
简要总结
The purpose of this study is to investigate BMS-986165 given as a tablet 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 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- •Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive, and total body weight ≥ 50 kg (110 lb). BMI = weight (kg)/(height [m])2 at screening
- •Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.732
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
- •Current or recent (within 3 months of study drug administration) gastrointestinal disease that could impact upon the absorption of study drug
- •History or presence of clinically significant acute or chronic bacterial, fungal, or viral infection (eg, pneumonia, septicemia) within the 3 months prior to screening
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986165
Experimental
Oral and intravenous administration
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Absolute oral bioavailability (F) of BMS-986165 derived from plasma concentration versus time data
时间窗: 4 days
次要结局
- Incidence of nonserious adverse events (AE)(Up to 34 days)
- Number of clinically significant changes in ECG, vital signs, physical examination findings, or clinical laboratory tests(Up to 34 days)
- Incidence of serious adverse events (SAE)(Up to 34 days)
研究者
研究点 (1)
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