NCT04941755已完成1 期
A Phase 1 Open-label, 2-Period Crossover Study to Assess the Effect of Acid-reducing Agent Famotidine on the Pharmacokinetics of BMS-986256 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: 2021年6月25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) of BMS-986256
研究概览
简要总结
The purpose of this study is to investigate the effect of gastric pH changes induced by famotidine on the drug levels of BMS-986256.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 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 participants, defined as having no clinically significant deviations from normal in medical history
- •Weight ≥ 50 kg and body mass index between 18.0 kg/m2 and 32.0 kg/m2, inclusive, at screening
- •Normal renal function at screening
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent gastrointestinal (GI) disease that could impact upon the absorption of study treatment
- •Any major surgery within 4 weeks of study treatment administration
- •Significant history of GI abnormalities
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Sequence AB
Experimental
干预措施: BMS-986256 (Drug)
Sequence AB
Experimental
干预措施: Famotidine (Drug)
Sequence BA
Experimental
干预措施: BMS-986256 (Drug)
Sequence BA
Experimental
干预措施: Famotidine (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of BMS-986256
时间窗: Up to 19 days
Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of BMS-986256
时间窗: Up to 19 days
Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T)) of BMS-986256
时间窗: Up to 19 days
次要结局
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 45 days)
- Incidence of clinically significant changes in ECG parameters: QT interval(Up to 45 days)
- Incidence of clinically significant changes in ECG parameters: QTcF(Up to 45 days)
- Ratio of Cmax of BMS-986256 (with famotidine versus without famotidine)(Up to 45 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 45 days)
- Incidence of clinically significant changes in clinical laboratory values: Hematology tests(Up to 45 days)
- Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests(Up to 45 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 45 days)
- Incidence of clinically significant changes in ECG parameters: QRS(Up to 45 days)
- Incidence of clinically significant changes in Electrocardiogram (ECG) parameters: PR interval(Up to 45 days)
- Incidence of Adverse Events (AEs)(Up to 45 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 45 days)
- Incidence of clinically significant changes in clinical laboratory values: Chemistry tests(Up to 45 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 45 days)
- Ratio of AUC(0-T) of BMS-986256 (with famotidine versus without famotidine)(Up to 45 days)
- Apparent terminal plasma half-life (T-HALF) of BMS-986256(Up to 45 days)
- Apparent total body clearance (CLT/F) of BMS-986256(Up to 45 days)
- Apparent volume of distribution of terminal phase (Vz/F) of BMS-986256(Up to 45 days)
- Ratio of AUC(INF) of BMS-986256 (with famotidine versus without famotidine)(Up to 45 days)
- Time of maximum observed plasma concentration (Tmax) of BMS-986256(Up to 45 days)
研究者
研究点 (1)
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