NCT04113668已完成1 期
AN OPEN-LABEL, SINGLE-SEQUENCE, CROSSOVER STUDY TO INVESTIGATE THE EFFECTS OF UGT1A9 INHIBITOR DIFLUNISAL, AT STEADY-STATE, ON PHARMACOKINETICS OF A SINGLE DOSE OF BMS-986165 IN HEALTHY MALE AND FEMALE VOLUNTEERS
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2019年10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
- 48
- 试验地点
- 1
- 主要终点
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor
研究概览
简要总结
BMS-986165 Is broken down by the body through multiple pathways. This study Investigates the effect of blocking one pathway in the drug levels of BMS-986165 in health subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- •Women and men must agree to follow instructions for methods of contraception.
- •Participants must be willing and able to complete all study-specific procedures and visits.
- •A healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- •WOCBP must have a negative serum or urine pregnancy test within 24 hours prior to the start of study treatment.
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, including a history of active liver disease
- •History of biliary disorders, including Gilbert's syndrome or Dubin- Johnson disease, in addition to, current or recent gastrointestinal disease that could impact the absorption of study drug.
- •Participants using electronic cigarettes or nicotine-containing products who have stopped smoking less than 6 months prior to dosing on Day
- •Consumption of chargrilled meat, quinine, or any nutrient known to modulate CYP enzyme activity within 14 days prior to first administration of study treatment.
- •History of any significant drug allergy
- •Other inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A: Single Dose (BMS-986165)
Experimental
干预措施: BMS-986165 (Drug)
Arm B:Diflunisal and Single Dose (BMS-986165)
Experimental
干预措施: BMS-986165 (Drug)
Arm B:Diflunisal and Single Dose (BMS-986165)
Experimental
干预措施: diflunisal (Drug)
结局指标
主要结局
Area under the plasma concentration-time curve from time zero extrapolated to infinite time AUC(INF) for BMS-986165 with and without UGT1A9 inhibitor
时间窗: up to 14 days
Maximum observed plasma concentration (Cmax) of BMS-986165 with and without UGT1A9 inhibitor
时间窗: Up to 14 days
Area under the plasma concentration-time AUC (0-T) of BMS-986165 with and without UGT1A9 inhibitor
时间窗: up to 14 days
次要结局
- Number of changes in respiratory rate(up to 20 days)
- Number of Clinically significant changes in assessment of blood(up to 20 days)
- Number of changes in body temperature(up to 20 days)
- Number of clinical significant changes in lab assessment of blood serum(up to 48 days)
- Number of Clinically significant changes in lab assessment of urine(up to 20 days)
- Incidence of Adverse Events (AEs)(up to 48 days)
- Number of participants with 12-lead Electrocardiogram (ECG) Abnormalities(up to 48 days)
- Physical Examination of weight(up to 48 days)
- Number of changes in blood pressure(up to 20 days)
研究者
研究点 (1)
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