A Clinical Study to Evaluate the Relative Bioavailability of Enlicitide Tablet Formulations Compared to the Reference Formulation in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide
研究概览
简要总结
The goal of this study is to learn what happens to enlicitide (MK-0616) in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of enlicitide and if people tolerate 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
- 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:
- •Is in good health
- •Has a body-mass index (BMI) between 18 and 32 kg/m^2
排除标准
- •The key exclusion criteria include but are not limited to the following:
- •Has a history of clinically significant gastrointestinal disease that may impact drug absorption
- •Has a history of cancer (malignancy)
研究组 & 干预措施
Dose regimen A
Participants receive enlicitide orally at dose regimen A.
干预措施: Enlicitide (Drug)
Dose regimen B
Participants receive enlicitide orally at dose regimen B.
干预措施: Enlicitide (Drug)
Dose regimen C
Participants receive enlicitide orally at dose regimen C.
干预措施: Enlicitide (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide
时间窗: At designated timepoints up to approximately 50 days
Blood samples will be collected to determine the AUC0-Last of enlicitide.
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide
时间窗: At designated timepoints up to approximately 50 days
Blood samples will be collected to determine the AUC0-Inf of enlicitide.
Maximum Plasma Concentration (Cmax) of enlicitide
时间窗: At designated timepoints up to approximately 50 days
Blood samples will be collected to estimate Cmax of enlicitide.
次要结局
- Number of Participants Who Experience an Adverse Event (AE)(Up to approximately 56 days)
- Number of Participants Who Discontinue Study Intervention Due to an AE(Up to approximately 56 days)