NCT05866627招募中1 期
A Phase 1 Open-label, 2-Part Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of Afimetoran (BMS-986256) in Healthy Participants
Bristol-Myers Squibb2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2023年7月4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
- 招募中
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Time to attain maximum observed plasma concentration (Tmax)
研究概览
简要总结
The purpose of this study is to confirm there is no significant effect of gastric pH changes of famotidine on the drug levels of afimetoran in healthy 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
- •Weight ≥ 50 kilograms (kg), at screening and first admission, and body mass index between 18.0 kilogram per square meter (kg/m^2) and 32.0 kg/m^2, inclusive, at screening.
- •A negative QuantiFERON-TB Gold test result at screening or documentation of a negative result within 3 months before screening.
- •Normal renal function at screening as evidenced by an estimated glomerular filtration rate (eGFR) ≥ 80 milliliter per minute (mL/min)/1.732 m^2 calculated with the Chronic Kidney Disease Epidemiology Collaboration formula.
排除标准
- •Any significant acute or chronic medical illness.
- •Current or recent (within 3 months of study drug administration) gastrointestinal (GI) disease that could impact upon the absorption of study treatment.
- •GI surgery, including cholecystectomy, that could impact upon the absorption of study treatment, at the investigator's discretion.
研究组 & 干预措施
Afimetoran
Experimental
干预措施: Afimetoran (Drug)
Famotidine, followed by afimetoran
Experimental
干预措施: Famotidine (Drug)
Afimetoran, followed by famotidine + afimetoran
Experimental
干预措施: Famotidine (Drug)
Afimetoran, followed by famotidine + afimetoran
Experimental
干预措施: Afimetoran (Drug)
Famotidine + afimetoran, followed by afimetoran
Experimental
干预措施: Famotidine (Drug)
Famotidine + afimetoran, followed by afimetoran
Experimental
干预措施: Afimetoran (Drug)
Famotidine, followed by afimetoran
Experimental
干预措施: Afimetoran (Drug)
结局指标
主要结局
Time to attain maximum observed plasma concentration (Tmax)
时间窗: Up to 20 Days
Maximum observed plasma concentration (Cmax)
时间窗: Up to 20 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 20 Days
次要结局
- Number of participants with clinical laboratory abnormalities(Up to 52 Days)
- Number of participants with adverse events (AEs)(Up to 52 Days)
- Number of participants with vital sign abnormalities(Up to 52 Days)
- Number of participants with electrocardiogram (ECG) abnormalities(Up to 52 Days)
研究者
研究点 (2)
Loading locations...
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