A Clinical Study to Evaluate the Plasma Pharmacokinetics of a Single Dose of MK-4082 With and Without Diltiazem Coadministration in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4082
研究概览
简要总结
Researchers are looking for new weight loss medicines for people with higher body weight. The trial medicine, MK-4082, is different from similar weight loss medicines because people take it as a pill instead of an injection. Before giving a trial medicine to participants with a health condition, researchers first do trials in healthy participants to find a safe dose level (amount) of the trial medicine.
The goal of this study is to learn what happens to MK-4082 in a person's body over time. Researchers will compare what happens to levels of MK-4082 in people's blood when it is taken alone (Part 1, Period 1 and Part 2) and in combination with (Part 1, Period 2) another medicine called diltiazem. Researchers also want to learn about the safety of MK-4082 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
- Sequential
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Part 1 of the study is open label with no control. Part 2 of the study is double-blind and placebo-controlled.
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
- •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:
- •Has a history of previous surgical treatment for obesity that may induce malabsorption, history of bowel resection >20 cm, any malabsorption disorder, severe gastroparesis, or any GI procedure for weight loss
- •Had a recent pancreatitis or has a history of pancreatitis
研究组 & 干预措施
MK-4082
Participants will move sequentially through 2 periods in Part 1. In Period 1, participants will receive a single oral dose of MK-4082 on Day 1. In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days. In Part 2 participants receive a single dose of MK-4082 or placebo.
干预措施: MK-4082 (Drug)
MK-4082
Participants will move sequentially through 2 periods in Part 1. In Period 1, participants will receive a single oral dose of MK-4082 on Day 1. In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days. In Part 2 participants receive a single dose of MK-4082 or placebo.
干预措施: Diltiazem (Drug)
MK-4082
Participants will move sequentially through 2 periods in Part 1. In Period 1, participants will receive a single oral dose of MK-4082 on Day 1. In Period 2, participants will receive a single oral dose of MK-4082 on Day 1 plus oral diltiazem for multiple days. In Part 2 participants receive a single dose of MK-4082 or placebo.
干预措施: Rescue medication (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-4082
时间窗: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the AUC0-inf of MK-4082.
Maximum Plasma Concentration (Cmax) of MK-4082
时间窗: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the Cmax of MK-4082.
Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 31 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. The number of participants who experience an AE will be reported.
Number of Participants Who Discontinue Study Intervention Due to an AE
时间窗: Up to approximately 17 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. The number of participants who discontinue study intervention due to an AE will be reported.
Part 1: Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-∞) of MK-4082
时间窗: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the AUC0-∞ of MK-4082.
Part 1: Maximum Plasma Concentration (Cmax) of MK-4082
时间窗: At designated timepoints (up to approximately 1 week postdose)
Blood samples will be collected to determine the Cmax of MK-4082.
Part 1: Number of Participants Who Experience an Adverse Event (AE)
时间窗: Up to approximately 31 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. The number of participants who experience an AE will be reported.
Part 1: Number of Participants Who Discontinue Study Intervention Due to an AE
时间窗: Up to approximately 17 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. The number of participants who discontinue study intervention due to an AE will be reported.
次要结局
- Part 2: AUC0-∞ of MK-4082(At designated timepoints (up to approximately 1 week postdose))
- Part 2: AUC0-24 of MK-4082(At designated timepoints (up to 24 hours postdose))
- Part 2: Cmax of MK-4082(At designated timepoints (up to approximately 1 week postdose))
- Part 2: Time to maximum plasma concentration (Tmax) of MK-4082(At designated timepoints (up to approximately 1 week postdose))
- Part 2: Plasma concentration 24 hours postdose (C24) of MK-4082(24 hours postdose)
- Part 2: Apparent terminal half-life (t½) of MK-4082(At designated timepoints (up to approximately 1 week postdose))