A Clinical Study to Evaluate the Relative Bioavailability of MK-0616 Formulations in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of enlicitide decanoate
研究概览
简要总结
The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.
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
- 19 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
- •Medically healthy with no clinically significant medical history.
排除标准
- •Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
- •Has a history of cancer (malignancy).
研究组 & 干预措施
Enlicitide Decanoate Treatment A
Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach.
干预措施: Enlicitide decanoate (Drug)
Enlicitide Decanoate Treatment B
Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach.
干预措施: Enlicitide decanoate (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of enlicitide decanoate
时间窗: Predose and at designated timepoints (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 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate
时间窗: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of enlicitide decanoate
时间窗: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-inf of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of enlicitide decanoate
时间窗: Predose and at designated timepoints (up to 168 hours 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: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Apparent Terminal Half-Life (t1/2) of enlicitide decanoate
时间窗: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Apparent Clearance (CL/F) of enlicitide decanoate
时间窗: Predose and at designated timepoints (up to 168 hours 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: Predose and at designated timepoints (up to 168 hours 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 approximately 44 days)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 44 days)