A Study to Evaluate the Effect of Nemtabrutinib on the Pharmacokinetics of Digoxin in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin
研究概览
简要总结
The goal of the study is to learn what happens to levels of digoxin in a healthy person's body over time. Researchers will compare what happens to digoxin in the body when it is given with and without another medicine called nemtabrutinib. Researchers are testing if digoxin levels in the body are different when digoxin is given with or without nemtabrutinib.
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
- •Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization
- •Has a body mass index (BMI) 18.0 to 32.0 kg/m^2 (inclusive)
排除标准
- •Has a medical history that may confound the results of the study or poses an additional risk to the participant in the study
- •Has a hypersensitivity to digoxin and/or to other digitalis preparations including inactive ingredients (eg, lactose, corn starch and potato starch)
研究组 & 干预措施
Digoxin
Participants receive a single oral dose of digoxin (Treatment A).
干预措施: Digoxin (Drug)
Digoxin + Nemtabrutinib
Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B).
干预措施: Digoxin (Drug)
Digoxin + Nemtabrutinib
Participants receive a single oral dose of digoxin coadministered with a single oral dose of nemtabrutinib (Treatment B).
干预措施: Nemtabrutinib (Drug)
结局指标
主要结局
Area under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Digoxin
时间窗: At designated timepoints (up to approximately 7 days)
Blood samples will be collected to determine the AUC0-Inf of digoxin.
次要结局
- Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Digoxin(At designated timepoints (up to approximately 7 days))
- Maximum Plasma Concentration (Cmax) of Digoxin(At designated timepoints (up to approximately 7 days))
- Plasma Concentration 24 Hours Postdose (C24) of Digoxin(At designated timepoints (up to approximately 24 hours))
- Time to Maximum Plasma Concentration (Tmax) of Digoxin(Predose and at designated timepoints (up to approximately 7 days))
- Apparent Volume of Distribution (Vz/F) of Digoxin(At designated timepoints (up to approximately 7 days))
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 8 weeks)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 8 weeks)
- Apparent Terminal Half-life (t1/2) of Digoxin(At designated timepoints (up to approximately 7 days))
- Apparent Clearance (CL/F) of Digoxin(At designated timepoints (up to approximately 7 days))