A Randomized, Open-Label, Four-Cohort, Parallel Design Study to Evaluate the Effect of Itraconazole or Rifampin on the Single-Dose Pharmacokinetics of BMS-986205 in Normal Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 53
- 试验地点
- 1
- 主要终点
- AUC from time zero to time of last quantifiable concentration (AUC(0-T))
研究概览
简要总结
Assess the effects of itraconazole and rifampin on the pharmacokinetics, safety, and tolerability of BMS-986205.
详细描述
A randomized, open-label, parallel design study in healthy participants to assess the effects of itraconazole and rifampin on the single-dose pharmacokinetics of BMS-986205. Safety and tolerability data to be collected and assessed as well.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Body mass index 18.0 to 32.0 kg/m2, inclusive
- •Must have normal renal function demonstrated by GFR, calculated by Chronic Kidney Disease Epidemiology Collaboration formula
- •Women must not be of childbearing potential (cannot become pregnant)
排除标准
- •Any significant acute or chronic medical illness
- •History of glucose-6-phosphodiesterase (G6PD) deficiency
- •Personal or family history of cytochrome b5 reductase deficiency
- •Other protocol defined inclusion / exclusion criteria could apply
研究组 & 干预措施
Inhibition (Cohort 2)
Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4
干预措施: Itraconazole (Drug)
Induction (Cohort 3)
Single oral dose BMS-986205
干预措施: BMS-986205 (Drug)
Inhibition (Cohort 1)
Single oral dose BMS-986205
干预措施: BMS-986205 (Drug)
Inhibition (Cohort 2)
Daily oral itraconazole doses for 24 days; single oral dose BMS-986205 on day 4
干预措施: BMS-986205 (Drug)
Induction (Cohort 4)
Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8
干预措施: BMS-986205 (Drug)
Induction (Cohort 4)
Daily oral rifampin doses for21 days; single oral dose BMS-986205 on day 8
干预措施: Rifampin (Drug)
结局指标
主要结局
AUC from time zero to time of last quantifiable concentration (AUC(0-T))
时间窗: Up to 25 days
Measured by plasma concentration
AUC from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to 25 days
Measured by plasma concentration
Maximum observed plasma concentration (Cmax)
时间窗: Up to 25 days
Measured by plasma concentration
次要结局
- Number of participants with electrocardiogram abnormalities(Up to 25 days)
- Incidence of Adverse Events (AEs)(Up to 25 days)
- Number of participants with physical examination findings abnormalities(Up to 25 days)
- Number of participants with clinical laboratory abnormalities(Up to 25 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 76 days)