NCT06034899撤回1 期
A Phase 1, 2-part, Open-label, Randomized, 2-period, 2-sequence, Crossover Study to Evaluate the Effect of Food on the Pharmacokinetics of BMS-986196 Phase 2 Tablet Formulation at Two Dose Levels in Healthy Adult Participants
Bristol-Myers Squibb0 个研究点开始时间: 2023年9月22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
- 撤回
- 发起方
- 主要终点
- Maximum observed serum concentration (Cmax)
研究概览
简要总结
The purpose of this study is to assess the drug levels of BMS-986196 and to evaluate the effect of food (fasted versus fed [high-fat meal]) on the drug levels after administration of BMS-986196 tablet formulation at two dose levels in healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 participants and female participants without clinically significant deviation from normal, as determined by the investigator, in medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory assessments.
- •Body mass index of 18.0 to 35.0 kilograms/meter square (kg/m^2), inclusive, and body weight ≥ 50 kg.
- •Participant must agree and be willing to consume a standard high-fat meal (for example, which may contain gluten).
排除标准
- •Any significant acute or chronic medical illness in the assessment of the investigator.
- •Current or recent (within 3 months of study intervention) gastrointestinal (GI) disease that could possibly affect drug absorption, distribution, metabolism, and excretion (e.g., bariatric procedure)
- •Any major surgery, including GI surgery (for example, cholecystectomy and any other GI surgery) that could impact upon the absorption of study intervention (uncomplicated appendectomy and hernia repair are acceptable).
- •Note: Other protocol-defined inclusion/exclusion criteria apply.
研究组 & 干预措施
Part 1: BMS-986196 Dose 1 (Treatment B)
Experimental
干预措施: BMS-986196 (Drug)
Part 1: BMS-986196 Dose 1 (Treatment A)
Experimental
干预措施: BMS-986196 (Drug)
Part 2: BMS-986196 Dose 2 (Treatment A)
Experimental
干预措施: BMS-986196 (Drug)
Part 2: BMS-986196 Dose 2 (Treatment B)
Experimental
干预措施: BMS-986196 (Drug)
结局指标
主要结局
Maximum observed serum concentration (Cmax)
时间窗: Predose and post-dose up to Day 10
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC [0-T])
时间窗: Predose and post-dose up to Day 10
Time of Cmax (Tmax)
时间窗: Predose and post-dose up to Day 10
次要结局
- Number of participants with electrocardiogram (ECG) abnormalities(Up to Day 11)
- Number of participants with physical examination findings(Up to Day 11)
- Number of participants with adverse events (AEs)(Up to Day 36)
- Number of participants with vital sign abnormalities(Up to Day 11)
- Number of participants with clinical laboratory abnormalities(Up to Day 11)
- Number of participants with serious AEs (SAEs)(Up to Day 36)
- Change from baseline in columbia-suicide severity rating scale (C-SSRS) at day 11(Baseline, Day 11)
研究者
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