NCT03930602已完成1 期
An Open-label, Single-sequence Study to Investigate the Effects of Cytochrome P450 1A2 Inhibition on the Pharmacokinetics of BMS-986165 in Healthy Participants
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5月1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
- AUC(0-T) of BMS-986165
研究概览
简要总结
To compare the pharmacokinetic characteristics of BMS-986165 after a single-dose administration alone vs. in combination with fluvoxamine (CYP1A2 inhibitor)
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 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, electrocardiograms (ECGs), and clinical laboratory determinations in the opinion of the investigator.
- •Body mass index of 18 to 32 kilograms per square meter (kg/m2), inclusive, and body weight ≥ 50 kg, at screening.
- •Normal renal function at screening as evidenced by an estimated glomerular filtration rate (GFR) > 80 milliliter/minute/1.732 meter square calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
排除标准
- •Any significant acute or chronic medical condition that presents a potential risk to the participant and/or may compromise the objectives of the study,
- •Any major surgery within 4 weeks of study drug administration
- •Participants who currently smoke, as well as those who have stopped smoking less than 6 months prior to dosing on Day 1.
研究组 & 干预措施
BMS-986165+Fluvoxamine
Experimental
干预措施: BMS-986165 (Drug)
BMS-986165+Fluvoxamine
Experimental
干预措施: Fluvoxamine (Drug)
BMS-986165 only
Experimental
干预措施: BMS-986165 (Drug)
Fluvoxamine only
Experimental
干预措施: Fluvoxamine (Drug)
结局指标
主要结局
AUC(0-T) of BMS-986165
时间窗: 10 days
AUC(INF) of BMS-986165
时间窗: 10 days
Maximum observed plasma concentration (Cmax) of BMS-986165
时间窗: 10 days
次要结局
- Percentage of participants with Serious Adverse events (SAEs) and Death(From screening up to end of drug treatment (Day 13))
- Fluvoxamine steady-state plasma concentrations(10 days)
- Percentage of participants with Adverse events (AEs)(From screening up to end of drug treatment (Day 13))
- Percentage of participants with clinical significant laboratory abnormalities vital sign measurements and ECGs(From screening up to end of drug treatment (Day 13))
- Percentage of participants with Adverse events (AEs) leading to discontinutation(From screening up to end of drug treatment (Day 13))
研究者
研究点 (1)
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