A Clinical Study to Evaluate the Relative Bioavailability of FDC Tablets Containing Enlicitide and Rosuvastatin, Compared to Enlicitide and Rosuvastatin Administered Concomitantly as Single Entities, in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
研究概览
简要总结
This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.
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 main inclusion criteria include but are not limited to the following:
- •Is medically healthy with no clinically significant medical history
- •Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry
排除标准
- •Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry
- •Is a female participant of childbearing potential
研究组 & 干预措施
Enlicitide + Rosuvastatin Part 2
Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
干预措施: Rosuvastatin (Drug)
MK-0616A Part 1
Participants in Part 1 will receive a single dose of MK-0616A
干预措施: MK-0616A (Drug)
MK-0616A Part 2
Participants in Part 2 will receive a single dose of MK-0616A formulation B
干预措施: MK-0616A (Drug)
Enlicitide + Rosuvastatin Part 2
Participants in Part 2 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
干预措施: Enlicitide (Drug)
Enlicitide + Rosuvastatin Part 1
Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
干预措施: Rosuvastatin (Drug)
Enlicitide + Rosuvastatin Part 1
Participants in Part 1 will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet
干预措施: Enlicitide (Drug)
结局指标
主要结局
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide
时间窗: Pre dose and at designated time points up to 168 hours post dose
Blood samples will be collected to determine the AUC0-inf of enlicitide in plasma
AUC0-Inf of Rosuvastatin
时间窗: Pre dose and at designated time points up to 168 hours post dose
Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitde
时间窗: Pre dose and at designated time points up to 168 hours post dose
Blood samples will be collected to determine the AUC0-last of enlicitide in plasma
AUC0-Last of Rosuvastatin
时间窗: Pre dose and at designated time points up to 168 hours post dose
Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma
Maximum Plasma Concentration (Cmax) of Enlicitide
时间窗: Pre dose and at designated time points up to 168 hours post dose
Blood samples will be collected to determine the cmax of enlicitide in plasma
Cmax of Rosuvastatin
时间窗: Pre dose and at designated time points up to 168 hours post dose
Blood samples will be collected to determine the cmax of rosuvastatin in plasma
次要结局
- Number of Participants who Experience an Adverse Event (AE)(Up to approximately 9 weeks)
- Number of Participants Who Discontinue Study Treatment Due to an AE(Up to approximately 8 days after first dose)