An Open-Label, Single-Sequence Crossover, Drug-Drug Interaction Study to Assess the Effect of Steady-State Branebrutinib on the Pharmacokinetics of Rosuvastatin in Healthy Participants
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 rosuvastatin
研究概览
简要总结
The purpose of this study is to examine the interaction of branebrutinib with rosuvastatin. Rosuvastatin is a substrate of the breast cancer resistance protein (BCRP) transporter, which has a drug level profile that can be markedly altered by coadministration of known inhibitors of the BCRP transporter. With widespread use of statins as cholesterol-lowering agents, rosuvastatin is also a likely concomitant drug for participants who would potentially be treated with branebrutinib.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations by investigator
- •Body mass index (BMI) of 18.0 kg/m2 to 32.0 kg/m2, inclusive, as measured at screening visit
- •Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial
排除标准
- •Women who are of childbearing potential
- •Women who are pregnant or breastfeeding
- •Any significant acute or chronic medical illness that presents a potential risk to the participant in the opinion of the investigator and/or may compromise the objectives of the study, including a history of or active liver disease
- •Any other sound 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
Period A: Rosuvastatin
干预措施: Rosuvastatin (Drug)
Period B: Branebrutinib
干预措施: Branebrutinib (Drug)
Period C: Branebrutinib + Rosuvastatin and Branebrutinib
干预措施: Rosuvastatin (Drug)
Period C: Branebrutinib + Rosuvastatin and Branebrutinib
干预措施: Branebrutinib (Drug)
Period D: Branebrutinib
干预措施: Branebrutinib (Drug)
结局指标
主要结局
Maximum observed plasma concentration (Cmax) of rosuvastatin
时间窗: Up to 6 days
Maximum observed plasma concentration (Cmax) of rosuvastatin when coadministered with branebrutinib
时间窗: Day 13
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin when coadministered with branebrutinib
时间窗: Day 13
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin
时间窗: Up to 6 days
Area under the concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of rosuvastatin
时间窗: Up to 6 days
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration [AUC(0-T)] of rosuvastatin when coadministered with branebrutinib
时间窗: Day 13
次要结局
- Incidence of Adverse Events (AEs)(Up to 33 days)
- Incidence of Serious Adverse Events (SAEs)(Up to 77 days)
- Incidence of AEs leading to discontinuation(Up to 33 days)
- Incidence of clinically significant changes in vital signs: Body temperature(Up to 54 days)
- Incidence of clinically significant changes in vital signs: Respiratory rate(Up to 54 days)
- Incidence of clinically significant changes in vital signs: Blood pressure(Up to 54 days)
- Incidence of clinically significant changes in vital signs: Heart rate(Up to 54 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval(Up to 54 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval(Up to 54 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval(Up to 54 days)
- Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval(Up to 54 days)
- Incidence of clinically significant changes in clinical laboratory results: Hematology tests(Up to 53 days)
- Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests(Up to 53 days)
- Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests(Up to 53 days)