NCT05852769已完成1 期
A Phase 1, Single-center, Open-label, Sequential Study to Evaluate the Drug-drug Interaction Potential of BMS-986196 in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2023年5月31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
- 18
- 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])
研究概览
简要总结
This study is designed to assess the effect of BMS-986196 on the drug levels of caffeine, montelukast, flurbiprofen, omeprazole, midazolam, digoxin, and pravastatin in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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 male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations.
- •Body mass index of 18.0 to 33.0 kilogram per meter squared (kg/m^2), inclusive, and body weight ≥50.0 kg.
排除标准
- •History of rhabdomyolysis.
- •History of peptic ulcer disease or significant GI bleeding.
- •History of malignancy in the 5 years prior to screening (except fully excised basal cell carcinoma).
研究组 & 干预措施
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Pravastatin (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: BMS-986196 (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Caffeine (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Montelukast (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Flurbiprofen (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Omeprazole (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Midazolam (Drug)
BMS-986196 and/or Cocktail Probe Substrate Drugs
Experimental
干预措施: Digoxin (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])
时间窗: Up to 26 days
Maximum observed plasma concentration (Cmax)
时间窗: Up to 26 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 26 days
次要结局
- Number of participants with adverse events (AEs)(Up to 52 days)
- Number of participants with vital sign abnormalities(Up to 28 days)
- Number of participants with physical examination abnormalities(Up to 28 days)
- Number of participants with clinical laboratory abnormalities(Up to 28 days)
- Intensity of Suicidal Ideation as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) Score(Up to 28 days)
- Time of maximum observed serum concentration (Tmax)(Up to 26 days)
- Apparent terminal phase half-life (T-Half)(Up to 26 days)
- Apparent total body clearance (CLT/F)(Up to 26 days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 21 days)
研究者
研究点 (1)
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