NCT05932277已完成1 期
A Phase 1 Open-label Study to Assess the Effect of BMS-986419 on the Single Dose Pharmacokinetics of Probe Substrates (Caffeine, Bupropion, Flurbiprofen, Omeprazole, Midazolam, and Fexofenadine) in Healthy Participants
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2023年6月29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
- 22
- 试验地点
- 1
- 主要终点
- Maximum observed plasma concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the effect of BMS-986419 on the pharmacokinetics (PK) of single doses of caffeine (CYP1A2 substrate), bupropion (CYP2B6 substrate), midazolam (CYP3A4 substrate), flurbiprofen (CYP2C9 substrate), omeprazole (CYP2C19 substrate), and fexofenadine (P-gp substrate), in healthy participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 male and female participants without clinically significant deviation from normal in medical history, physical examination (PE), electrocardiogram (ECG), and clinical laboratory determinations (congenital nonhemolytic hyperbilirubinemia [eg, suspicion of Gilbert's syndrome based on total and direct bilirubin] is not acceptable) at screening and check-in (Day -1).
- •Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive, and total body weight ≥ 50 kg. BMI may be rounded.
排除标准
- •Any significant acute or chronic medical conditions or any significant acute or chronic medical illness as determined by the investigator
- •Any major surgery within 30 days of study intervention administration, such as gastrointestinal surgery that could impact the absorption of study intervention
- •Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: Bupropion (Drug)
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: BMS-986419 (Drug)
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: Caffeine (Drug)
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: Flurbiprofen (Drug)
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: Omeprazole (Drug)
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: Midazolam (Drug)
Cocktail Probe Substrates + BMS-986419
Experimental
干预措施: Fexofenadine (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax)
时间窗: Up to Day 25
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 Day 25
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))
时间窗: Up to Day 25
次要结局
- Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))(Up to Day 25)
- Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF))(Up to Day 25)
- Number of participants with Serious Adverse Events (SAEs)(Up to 28 days after last dose)
- Number of participants with clinical laboratory abnormalities(Up to Day 25)
- Maximum observed plasma concentration (Cmax)(Up to Day 25)
- Number of participants with Adverse Events (AEs)(Up to 28 days after last dose)
- Number of participants with AEs leading to discontinuation(Up to 28 days after last dose)
- Number of participants with vital sign abnormalities(Up to Day 25)
- Number of participants with 12-lead ECG assessment abnormalities(Up to Day 25)
- Number of participants with physical examination abnormalities(Up to Day 25)
- Columbia-Suicide Severity Rating Scale (C-SSRS)(Up to Day 25)
研究者
研究点 (1)
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