A Clinical Study to Evaluate the Effect of Food and Water Volume on the Pharmacokinetics of the MK-0616 Final Market Formulation in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
研究概览
简要总结
Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection.
The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
- •Is medically healthy with no clinically significant medical history
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has history of gastrointestinal disease which may affect food and drug absorption
- •Has history of cancer (malignancy).
研究组 & 干预措施
Enlicitide Decanoate Food Effect
Participants will be administered enlicitide decanoate on Day 1 with or without food.
干预措施: Enlicitide decanoate (Drug)
Enlicitide Decanoate Water Effect
Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.
干预措施: Enlicitide decanoate (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Lag Time (tlag) of Enlicitide Decanoate in Plasma
时间窗: Pre-dose and at designated time points up to 1 week postdose
Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.
Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Apparent Clearance (CL/F) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate
时间窗: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to 14 days postdose)
- Number of Participants Who Discontinue Study Due to an AE(Up to 14 days postdose)