A Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-Dose Pharmacokinetics of Nemtabrutinib in Healthy Participants.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Nemtabrutinib
研究概览
简要总结
The goal of the study is to learn what happens to levels of nemtabrutinib (MK-1026) in a healthy person's body over time. Researchers will compare what happens to nemtabrutinib in the body when it is given with or without another medicine called diltiazem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 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
- •Be in good health
- •BMI between 18.5 and 32 kg/m2, inclusive
排除标准
- •History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological (history of a bleeding disorder, abnormal bleeding or a hereditary or acquired coagulation or platelet disorder), hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke, intercranial hemorrhage, and chronic seizures) abnormalities or diseases
- •History of cancer (malignancy)
研究组 & 干预措施
Period 2: Diltiazem + Nemtabrutinib
Participants will receive diltiazem plus nemtabrutinib.
干预措施: Diltiazem (Drug)
Period 1: Nemtabrutinib
Participants will receive nemtabrutinib followed by a protocol specified wash-out period.
干预措施: Nemtabrutinib (Drug)
Period 2: Diltiazem + Nemtabrutinib
Participants will receive diltiazem plus nemtabrutinib.
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 Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
Maximum Plasma Concentration (Cmax) of Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the Cmax of nemtabrutinib.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the AUC0-last of nemtabrutinib.
Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the Tmax of nemtabrutinib.
Apparent Terminal Half-life (t1/2) of Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the t1/2 of nemtabrutinib.
Apparent Clearance (CL/F) of Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the CL/F of nemtabrutinib.
Volume of Distribution During Terminal Phase (Vz/F) of Nemtabrutinib
时间窗: Up to approximately 4 weeks
Blood samples will be collected to determine the Vz/F of nemtabrutinib.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 5 weeks)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 3 weeks)