A Study to Evaluate the Effect of Multiple Oral Doses of Efavirenz 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
- 16
- 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 efavirenz.
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Period 1: Nemtabrutinib
Participants receive a single dose of nemtabrutinib followed by a protocol specified wash-out period.
干预措施: Nemtabrutinib (Drug)
Period 2: Nemtabrutinib + Efavirenz
Participants receive oral doses of efavirenz once daily on Days 1 to 24 with a single oral dose of nemtabrutinib given with efavirenz on Day 11.
干预措施: Nemtabrutinib (Drug)
Period 2: Nemtabrutinib + Efavirenz
Participants receive oral doses of efavirenz once daily on Days 1 to 24 with a single oral dose of nemtabrutinib given with efavirenz on Day 11.
干预措施: Efavirenz (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: Predose and at designated time points (up to 2 weeks)
Blood samples will be collected to determine the AUC0-inf of nemtabrutinib.
次要结局
- Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Nemtabrutinib(Predose and at designated time points (up to 24 hours postdose))
- Maximum Plasma Concentration (Cmax) of Nemtabrutinib(Predose and at designated time points (up to 2 weeks))
- Time to Maximum Plasma Concentration (Tmax) of Nemtabrutinib(Predose and at designated time points (up to 2 weeks postdose))
- Apparent Clearance (CL/F) of Nembrutinib(Predose and at designated time points (up to 2 weeks))
- Apparent Volume of Distribution During Terminal Phase (Vz/F) Nemtabrutinib(Predose and at designated time points (up to 2 weeks))
- Apparent Terminal Half-life (t1/2) of Nemtabrutinib(Predose and at designated time points (up to 2 weeks))
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 2 months)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 2 months)