NCT05932303已完成1 期
A Phase 1, 3-arm, Open-label, Sequential Design Study to Investigate the Effect of Multiple Doses of Itraconazole, Gemfibrozil, or Carbamazepine on Single-dose Pharmacokinetics of BMS-986278 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 47 人开始时间: 2023年7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
- 47
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
This is a study in healthy participants designed to assess the effect of multiple doses of itraconazole, gemfibrozil, or carbamazepine on the drug levels of a single-dose of BMS-986278.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) of 18.0 kilograms per meter squared (kg/m^2) through 32.0 kg/m^2, inclusive.
- •BMI = weight (kg)/(height [m])
- •Body weight ≥ 50 kg for males and ≥ 45 kg for females.
排除标准
- •Any significant acute or chronic medical illness.
- •Any gastrointestinal disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. Note: Appendectomy is allowed.
- •Any major surgery within 4 weeks of study intervention administration.
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
BMS-986278, followed by itraconazole
Experimental
干预措施: BMS-986278 (Drug)
BMS-986278, followed by itraconazole
Experimental
干预措施: Itraconazole (Drug)
BMS-986278, followed by gemfibrozil
Experimental
干预措施: BMS-986278 (Drug)
BMS-986278, followed by gemfibrozil
Experimental
干预措施: Gemfibrozil (Drug)
BMS-986278, followed by carbamazepine
Experimental
干预措施: BMS-986278 (Drug)
BMS-986278, followed by carbamazepine
Experimental
干预措施: Carbamazepine (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to 33 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC[0-T])
时间窗: Up to 33 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC[INF])
时间窗: Up to 33 days
次要结局
- Number of participants with adverse events (AEs)(Up to 33 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 33 days)
- Number of participants with physical examination abnormalities(Up to 33 days)
- Number of participants with vital sign abnormalities(Up to 33 days)
- Number of participants with clinical laboratory abnormalities(Up to 33 days)
研究者
研究点 (1)
Loading locations...
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