A Clinical Study to Evaluate the Effect of MK-0616 and Semaglutide on Their Respective Pharmacokinetics in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
研究概览
简要总结
The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time. Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Semaglutide is a drug used to treat type 2 diabetes.
Researchers want to learn what happens to the amount of semaglutide and enlicitide decanoate in a person's blood when each drug is taken alone and when they are taken together.
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
- 19 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:
- •Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2
- •Medically healthy with no clinically significant medical history
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
- •History of cancer
研究组 & 干预措施
Enlicitide Decanoate and Semaglutide
Period 1: Participants receive an oral dose of enlicitide decanoate every day for 1 week.
Period 2: Participants receive an oral dose of semaglutide every day for 6 weeks.
Period 3: Participants receive an oral dose of both enlicitide decanoate and semaglutide every day for 1 week.
干预措施: Enlicitide Decanoate (Drug)
Enlicitide Decanoate and Semaglutide
Period 1: Participants receive an oral dose of enlicitide decanoate every day for 1 week.
Period 2: Participants receive an oral dose of semaglutide every day for 6 weeks.
Period 3: Participants receive an oral dose of both enlicitide decanoate and semaglutide every day for 1 week.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
时间窗: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide
时间窗: At designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24hrs of semaglutide.
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of Semaglutide
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Cmax of semaglutide.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Time to Maximum Plasma Concentration (Tmax) of Semaglutide
时间窗: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Tmax of semaglutide.
次要结局
- Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)(Up to approximately 12 weeks)
- Number of Participants Who Discontinue Study Due to a TEAE(Up to approximately 12 weeks)