A Clinical Study to Evaluate the Effect of Fasting Duration on the Pharmacokinetics of the Enlicitide in Healthy Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
研究概览
简要总结
The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.
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:
- •Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2
排除标准
- •The main 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 (malignancy)
- •Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
- •History of a major surgery
- •Is lactose intolerant
研究组 & 干预措施
Enlicitide Treatment A
Participants receive single oral dose of enlicitide after 8-hour overnight fast.
干预措施: Enlicitide (Drug)
Enlicitide Treatment B
Participants receive single oral dose of enlicitide 4 hours after morning meal.
干预措施: Enlicitide (Drug)
Enlicitide Treatment C
Participants receive single oral dose of enlicitide 3 hours after morning meal.
干预措施: Enlicitide (Drug)
Enlicitide Treatment D
Participants receive single oral dose of enlicitide 2 hours after morning meal.
干预措施: Enlicitide (Drug)
结局指标
主要结局
Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
AUC0-inf of enlicitide in plasma will be determined.
Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 24 hours post dose
AUC0-24 of enlicitide in plasma will be determined.
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
AUC0-last of enlicitide in plasma will be determined.
Maximum plasma concentration (Cmax) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
Cmax of enlicitide in plasma will be determined.
Time to maximum plasma concentration (Tmax) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
Tmax of enlicitide in plasma will be determined.
Apparent terminal half-life (t1/2) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
t1/2 of enlicitide in plasma will be determined.
Apparent Clearance (CL/F) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
CL/F of enlicitide in plasma will be determined.
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
Vz/F of enlicitide in plasma will be determined.
Lag Time (tlag) of enlicitide in plasma
时间窗: Pre-dose and at designated time points up to 168 hours post dose
tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.
次要结局
- Number of participants who experience one or more adverse events (AEs)(Up to ~ 14 days)
- Number of participants who discontinue study intervention due to an AE(Up to ~ 14 days)