An Open-Label, Single-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide
研究概览
简要总结
Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward,
The purpose of this study is to learn what happens to enlicitide in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to enlicitide in the body when it is given to people with hepatic impairment (HI- meaning the liver does not work properly) and people who are in good health.
This study will have 2 parts. In Part 1, enlicitide will be given to people with moderate HI and people who are in good health. After Part 1, researchers may decide to include people who have mild HI and compare what happens to enlicitide in the body with people who are in good health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older 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:
- •All participants:
- •Has been a non-smoker or moderate smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to starting the study
- •Has body mass index (BMI) ≥ 18.0 and ≤ 40.0 kg/m2
- •Participants with moderate or mild HI:
- •Diagnosis of chronic (> 6 months) and stable (no sudden or severe episodes of illness due to worsening liver function in the past 2 months) hepatic insufficiency, and features cirrhosis (liver scarring) due to any cause.
- •Is generally in good health with the exception of HI.
- •Healthy Control Participants:
- •Medically healthy with no clinically significant medical history, physical examination, or clinical laboratory profiles
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •All participants:
- •History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery.
- •History of cancer
- •Consumes greater than 3 servings of alcoholic beverages per day.
- •Is on statin background therapy.
- •Participants with moderate or mild HI:
- •Severe complications of liver disease within 3 months of entering the study.
研究组 & 干预措施
Moderate Hepatic Impairment (HI)
Participants will receive a single oral dose of enlicitide on Day 1
干预措施: Enlicitide (Drug)
Healthy Controls
Participants will receive a single oral dose of enlicitide on Day 1
干预措施: Enlicitide (Drug)
Mild HI
Participants will receive a single oral dose of enlicitide on Day 1
干预措施: Enlicitide (Drug)
结局指标
主要结局
Part 1: Area under the concentration versus time curve from 0 to infinity (AUC0-inf)AUC0-inf of enlicitide
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.
Part 1: Maximum concentration (Cmax) of enlicitide
时间窗: Predose, and at designated timepoints up to 168 hours post-dose
Cmax of enlicitide in plasma will be determined
Part 2: AUC 0-inf of enlicitide
时间窗: Pre-dose and at designated timepoints up to 168 hours post dose
AUC 0-inf of enlicitide in plasma will be determined
Part 2: Cmax of enlicitide
时间窗: Predose, and at designated timepoints up to 168 hours post-dose
Cmax of enlicitide in plasma will be determined
次要结局
- Part 1: Area under the concentration versus time curve from 0 to the time of the last quantifiable sample (AUC0-last) of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 1: Number of participants who experience one or more adverse events (AEs)(Up to approximately 6 weeks)
- Part 1: Number of participants who discontinue study intervention due to an AE(Up to approximately 6 weeks)
- Part 2: AUC0-24 of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2: AUC0-last of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2: Tmax observed plasma drug concentration of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2: t1/2 of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2: CL/F of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2: Vz/F of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2 Number of participants who experience one or more adverse events (AEs)(Up to approximately 6 weeks)
- Part 1: Time to maximum (Tmax) observed plasma drug concentration of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 1: Area under the concentration versus time curve from 0 to 24 hours (AUC0-24) of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 1: Apparent clearance (CL/F) of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 1: Apparent volume of distribution during terminal phase (Vz/F) of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 1: Apparent terminal half-life (t1/2) of enlicitide(Pre-dose and at designated timepoints up to 168 hours post dose)
- Part 2: Number of participants who discontinue study intervention due to an AE(Up to approximately 6 weeks)