A Two-period Study to Evaluate the Effects of Multiple Oral Doses of Diltiazem on the Single-dose Pharmacokinetics of MK-4318 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318
研究概览
简要总结
The goal of this study is to learn what happens to MK-4318 in a person's body over time. Researchers will compare what happens to levels of MK-4318 in people's blood when it is taken with and without diltiazem. Researchers also want to learn about the safety of MK-4318 taken with and without diltiazem and if people tolerate them.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 55 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
MK-4318 Plus Diltiazem
Participants will move sequentially through 2 Periods. In Period 1, participants receive MK-4318 orally. In Period 2, participants receive MK-4318 orally plus diltiazem orally.
干预措施: MK-4318 (Drug)
MK-4318 Plus Diltiazem
Participants will move sequentially through 2 Periods. In Period 1, participants receive MK-4318 orally. In Period 2, participants receive MK-4318 orally plus diltiazem orally.
干预措施: Diltiazem (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4318
时间窗: At designated timepoints (up to approximately 4 days postdose)
Blood samples will be collected to determine the AUC0-inf of MK-4318 in the presence of diltiazem.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318
时间窗: At designated timepoints (up to approximately 1 day postdose)
Blood samples will be collected to determine the AUC0-24hrs of MK-4318 in the presence of diltiazem.
Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs)
时间窗: At designated timepoints (up to approximately 12 hours postdose)
Blood samples will be collected to determine the C12hrs of MK-4318 in the presence of diltiazem.
Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs)
时间窗: At designated timepoints (up to approximately 1 day postdose)
Blood samples will be collected to determine the C24hrs of MK-4318 in the presence of diltiazem.
Maximum Plasma Concentration (Cmax) of MK-4318
时间窗: At designated timepoints (up to approximately 4 days postdose)
Blood samples will be collected to determine the Cmax of MK-4318 in the presence of diltiazem.
Time to Maximum Plasma Concentration (Tmax) of MK-4318
时间窗: At designated timepoints (up to approximately 4 days postdose)
Blood samples will be collected to determine the Tmax of MK-4318 in the presence of diltiazem.
Apparent Clearance (CL/F) of MK-4318
时间窗: At designated timepoints (up to approximately 4 days postdose)
Blood samples will be collected to determine the CL/F of MK-4318 in the presence of diltiazem.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318
时间窗: At designated timepoints (up to approximately 4 days postdose)
Blood samples will be collected to determine the Vz/F of MK-4318 in the presence of diltiazem.
Apparent Terminal Half-life (t1/2) of MK-4318
时间窗: At designated timepoints (up to approximately 4 days postdose)
Blood samples will be collected to determine the t1/2 of MK-4318 in the presence of diltiazem.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 60 days)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 9 days)