A Phase 1, Open-Label, Fixed-Sequence Study to Evaluate the Effect of Multiple Doses of Diltiazem on the Single-Dose Pharmacokinetics of MK-1167 in Healthy Adult 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
- Number of participants who experience one or more adverse events (AEs)
研究概览
简要总结
The goal of this study this study is to learn about the safety of MK-1167 and if people tolerate it. Researchers will compare what happens to MK-1167 in the body when it is given with and 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
- 19 Years 至 50 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:
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting
- •Body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- •Able to swallow multiple capsules
- •In good health
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History or presence of second- or third-degree atrioventricular heart block (except in participants with a functional artificial pacemaker)
- •History or presence of clinically significant sick sinus syndrome
- •History of cancer (malignancy) within the past 5 years
- •Unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to the first dosing
研究组 & 干预措施
MK-1167 Period 1
On Day 1 a single dose of MK-1167 will be administered.
干预措施: MK-1167 (Drug)
MK-1167 Period 2
There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3.
干预措施: MK-1167 (Drug)
MK-1167 Period 2
There will be a washout of at least 35 days between MK-1167 dosing in Period 1 and the first diltiazem dose in Period 2. In Period 2, diltiazem will be administered once daily (QD) for 49 consecutive days with a single dose of MK-1167 coadministered on Day 3.
干预措施: Diltiazem (Drug)
结局指标
主要结局
Number of participants who experience one or more adverse events (AEs)
时间窗: Up to approximately 99 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study intervention due to an AE
时间窗: Up to approximately 85 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-1167 in plasma
时间窗: Predose, and at designated timepoints up to 50 days post-dose
AUC0-inf of MK-1167 in plasma will be determined.
次要结局
- Apparent clearance (CL/F) of MK-1167 in plasma(Predose, and at designated timepoints up to 50 days post-dose)
- Apparent volume of distribution during terminal phase (Vz/F) of MK-1167 in plasma(Predose, and at designated timepoints up to 50 days post-dose)
- Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-1167 in plasma(Predose, and at designated timepoints up to 50 days post-dose)
- Maximum concentration (Cmax) of MK-1167 in plasma(Predose, and at designated timepoints up to 50 days post-dose)
- Concentration at hour 24 (C24) of MK-1167 in plasma(Predose, and at designated timepoints up to 24 hours post-dose)
- Time to maximum concentration (Tmax) of MK-1167 in plasma(Predose, and at designated timepoints up to 50 days post-dose)
- Apparent terminal half-life (t1/2) of MK-1167 in plasma(Predose, and at designated timepoints up to 50 days post-dose)