A Study to Evaluate the Effects of Coadministration of Diltiazem on the Plasma Pharmacokinetics of a Single Dose of MK-6552 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Maximum Plasma Concentration (Cmax) of MK-6552
研究概览
简要总结
The main goal of this study is to learn what happens to MK-6552 in a person's body over time (a pharmacokinetic or PK study). Researchers want to know what happens to MK-6552 in healthy adults when a single dose of MK-6552 is given with multiple doses of diltiazem. The researchers believe that multiple doses of diltiazem will not affect the highest amount of MK-6552 in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •The main inclusion criteria include but are not limited to the following:
- •Is in good health before randomization
- •Body Mass Index (BMI) between 18 and 32 kg/m^2, inclusive
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases
- •History of cancer (malignancy)
研究组 & 干预措施
MK-6552 + Diltiazem
Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552.
干预措施: MK-6552 (Drug)
MK-6552 + Diltiazem
Participants receive a single dose of MK-6552 on Period 1 Day 1. Participants receive a Diltiazem every day (QD) for 6 days (Period 2 Days 1-6). On Period 2 Day 2 participants receive a single dose of MK-6552.
干预措施: Diltiazem (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of MK-6552
时间窗: Pre-dose and at designated time points up to 24 hours post dose
Blood samples will be collected to determine the Cmax of MK-6552 in plasma.
次要结局
- Number of Participants Who Experience and Adverse Event (AEs)(Up to approximately 20 days)
- Number of Participants Who Discontinue Study Due to an AE(Up to approximately 20 days)
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-6552(Pre-dose and at designated time points up to 96 hours post dose)
- Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24) of MK-6552(Pre-dose and at designated time points up to 24 hours post dose)
- Time to Maximum Plasma Concentration (Tmax) of MK-6552(Pre-dose and at designated time points up to 96 hours post dose)
- Concentration of MK-6552 at 6 Hours Postdose (C6h)(Pre-dose and at designated time points up to 6 hours post dose)
- Concentration of MK-6552 at 8 Hours Postdose (C8h)(Pre-dose and at designated time points up to 8 hours post dose)
- Apparent Clearance (CL/F) of MK-6552(Pre-dose and at designated time points up to 96 hours post dose)
- Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-6552(Pre-dose and at designated time points up to 96 hours post dose)
- Apparent Terminal Half-Life (t1/2) of MK-6552(Pre-dose and at designated time points up to 96 hours post dose)