NCT03563950已完成1 期
A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2018年6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
- 42
- 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)] of BMS-986224
研究概览
简要总结
The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.
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
- 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, ECGs, and clinical laboratory determinations
- •Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening
排除标准
- •Women of childbearing potential
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy
- •Other protocol defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Rifampin + BMS-986224
Experimental
Oral administration
干预措施: Rifampin (Drug)
Rifampin + BMS-986224
Experimental
Oral administration
干预措施: BMS-986224 (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)] of BMS-986224
时间窗: 5 days
Maximum observed plasma concentration (Cmax) of BMS-986224
时间窗: 5 days
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
时间窗: 5 days
次要结局
- Biomarker plasma concentrations of BMS-986224(5 days)
- Time of maximum observed plasma concentration (Tmax) of BMS-986224(5 days)
- Terminal elimination half-life (T-HALF) of BMS-986224(5 days)
- Metabolite of BMS-986224 Cmax(5 days)
- Metabolite of BMS-986224 AUC(0-T)(5 days)
- Metabolite of BMS-986224 AUC(INF)(5 days)
- Incidence of nonserious adverse events (AE)(17 days)
- Incidence of serious adverse events (SAE)(30 days)
- Incidence of AEs leading to discontinuation(17 days)
- Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests(18 days)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
An Investigational Study to Evaluate Experimental Medication BMS-986224 in Renally Impaired ParticipantsCardiac FailureMyocardial FailureNCT03634969Bristol-Myers Squibb50
已完成
1 期
Study to Assess Drug Levels and Safety of BMS-986278 in Healthy Participants and Participants With Different Degrees of Hepatic ImpairmentHepatic ImpairmentHealthy ParticipantsNCT06425198Bristol-Myers Squibb37
已完成
1 期
A Study to Assess the Effect of BMS-986419 on the Single Dose Drug Levels of Probe Substrates in Healthy ParticipantsHealthy VolunteersNCT05932277Bristol-Myers Squibb22
已完成
1 期
An Investigational Study of Experimental Medication BMS-986165 in Healthy ParticipantsHealthy ParticipantsNCT03660436Bristol-Myers Squibb131
招募中
1 期
A Study of BMS-986488 as Monotherapy and Combination Therapy in Participants With Advanced Malignant TumorsAdvanced Malignant TumorsNCT06764771Bristol-Myers Squibb437