NCT04086719已完成1 期
An Open-Label, Single Sequence, Crossover Study to Investigate the Effects of OCT1 Inhibition Utilizing Pyrimethamine on Pharmacokinetics of BMS-986165 in Healthy Male Volunteers.
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2019年9月12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
- 16
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero extrapolated to AUC(INF)
研究概览
简要总结
Study of what the body does to drug BMS-986165 when it is taken together with pyrimethamine
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 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
- •Patients must be willing and able to complete all study-specific procedures and visits
- •Healthy patients, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiogram, and clinical laboratory determinations
- •Body mass index (BMI) of 18 to 32 kg/m2, inclusive, at screening
- •Normal renal function at screening
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
- •Additional criteria may apply
研究组 & 干预措施
BMS- 986185 + Pyrimethamine
Experimental
干预措施: Pyrimethamine (Drug)
BMS-986185
Experimental
干预措施: BMS-986165 (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero extrapolated to AUC(INF)
时间窗: Day 1, Day 5
Maximum observed serum comcentration (Cmax)
时间窗: Day 1, Day 5
次要结局
- Incidences of Adverse Events (AE's)(Approximetly 20 days)
- Time of maximum observed concentration (Tmax)(Approxmiately 20 days)
- Half- life time (T-Half)(Day 1, Day 5)
- Apparent oral clearance (CL/F)(Day 5)
- Ratio of metabolite AUC(INF) to parent AUC(INF) corrected for Moecular weight MRAUC(INF)(Day 5)
- Apparent volume of distribution at terminal phase (Vz/F)(Day 5)
- Ratio of metabolite AUC(0-T) to parent AUC(0-T) corrected for Molecular weight MRAUC(0-T)(Day 5)
研究者
研究点 (1)
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