A 2-period, Fixed-sequence, Open-label Study to Evaluate the Effect of Multiple Oral Doses of Diltiazem on the Single-dose Pharmacokinetics of MK-6916 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916
研究概览
简要总结
The goal of the study is to learn what happens to levels of MK-6916 in a healthy person's body over time. Researchers will compare what happens to MK-6916 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
- 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 key inclusion criteria include but are not limited to the following:
- •Has a body-mass index (BMI) 18 to 32 kg/m^2
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological abnormalities or diseases
- •Has a history of cancer (malignancy)
- •Has a history of cardiac arrhythmia or recurrent unexplained syncopal events
- •Has a first-degree relative with multiple unexplained syncopal events, unexplained cardiac arrest or sudden cardiac death, or has a known family history of an inherited arrhythmia syndrome
- •Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus
研究组 & 干预措施
MK-6916 + Diltiazem
Participants will receive MK-6916 and diltiazem orally.
干预措施: MK-6916 (Drug)
MK-6916 + Diltiazem
Participants will receive MK-6916 and 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-6916
时间窗: Predose and at designated time points (up to 8 weeks)
Blood samples will be collected to determine the AUC0-inf of MK-6916.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916
时间窗: Predose and at designated time points (up to 24 hours)
Blood samples will be collected to determine the AUC0-24 of MK-6916.
Plasma Concentration at 24 Hours (C24) of MK-6916
时间窗: Predose and at designated time points (up to 24 hours)
Blood samples will be collected to determine the C24 of MK-6916.
Plasma Concentration at 12 Hours (C12) of MK-6916
时间窗: Predose and at designated time points (up to 12 hours)
Blood samples will be collected to determine the C12 of MK-6916.
Maximum Plasma Concentration (Cmax) of MK-6916
时间窗: Predose and at designated time points (up to 8 weeks)
Blood samples will be collected to determine the Cmax of MK-6916.
Time to Maximum Plasma Concentration (Tmax) of MK-6916
时间窗: Predose and at designated time points (up to 8 weeks)
Blood samples will be collected to determine the Tmax of MK-6916.
Apparent Clearance (CL/F) of MK-6916
时间窗: Predose and at designated time points (up to 8 weeks)
Blood samples will be collected to determine the CL/F of MK-6916.
Apparent Volume of Distribution (Vz/F) of MK-6916
时间窗: Predose and at designated time points (up to 8 weeks)
Blood samples will be collected to determine the Vz/F of MK-6916.
Apparent Terminal Half-life (t1/2) of MK-6916
时间窗: Predose and at designated time points (up to 8 weeks)
Blood samples will be collected to determine the t1/2 of MK-6916.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 8 weeks)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 8 weeks)