A Phase 1, Two-part, Open-label, Drug-drug Interaction Study in Healthy Male Adult Participants to Evaluate the Effects of BMS-986371 on the Pharmacokinetics of Methotrexate in the Presence and Absence of Sulfasalazine
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 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
The purpose of this study is to evaluate the effects of BMS-986371 on the drug levels of methotrexate, sulfasalazine and their main metabolites in healthy male adult participants.
详细描述
This study will allow investigation of potential drug-drug interaction mediated through drug transporter proteins. During each part, blood samples will be collected at prespecified times for pharmacokinetic assessments. Subject safety will be monitored throughout the study. There will be approximately 16 subjects enrolled into each part.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Participant has physical exam, vital signs, clinical laboratory safety and other medical test results that are within normal limits, considered not clinically significant by the Investigator, or within other parameters specified in the protocol
- •Body mass index of 18 to 32 kg/m^2, inclusive
排除标准
- •Any significant acute or chronic medical illness
- •Current or recent (within 3 months of study intervention administration) gastrointestinal disease that could possibly affect the absorption, distribution, metabolism and excretion of study drug
- •Any other medical, psychiatric and/or social reason as determined by the Investigator
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Part 2
干预措施: Sulfasalazine (Drug)
Part 1
干预措施: Methotrexate (Drug)
Part 1
干预措施: Leucovorin (Drug)
Part 1
干预措施: BMS-986371 (Drug)
Part 2
干预措施: Methotrexate (Drug)
Part 2
干预措施: Leucovorin (Drug)
Part 2
干预措施: BMS-986371 (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 22 days
Part 1
Maximum observed plasma concentration (Cmax)
时间窗: Up to 22 days
Part 1
Area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration (AUC[0-T])
时间窗: Up to 22 days
Part 1
次要结局
- AUC(0-T)(Up to 22 days)
- AUC(INF)(Up to 22 days)
- Cmax(Up to 22 days)
- Number of participants with adverse events (AEs)(Up to 30 days post participant's last study treatment)