An Open-Label, Multiple-Dose Clinical Study to Evaluate the Pharmacokinetics of Enlicitide in Participants With Severe Renal Impairment
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 5
- 主要终点
- Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
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 (PK) study). Researchers will compare what happens to enlicitide in the body when it is given to people with severe renal impairment (meaning the kidneys do not work properly) and to people who are in good health. The researchers believe that the total amount of enlicitide in a person's body measured during the 24 hours after a dose will be similar in people with severe renal impairment and in healthy people.
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 85 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:
- •Body Mass Index (BMI) between 18 and 40 kg/m^2, inclusive
- •On a stable dose of statin therapy; no changes to dose or type of statin therapy for at least 2 months
排除标准
- •The main exclusion criteria include but are not limited to the following:
- •History or presence of renal artery stenosis
- •Had a functioning renal transplant in the past 5 years and is taking transplant medication
- •History of gastrointestinal (GI) disease which might affect food and drug absorption
- •Panel A: Participants with Severe Renal Impairment:
- •History of any illness, other than hypercholesterolemia and Renal Impairment
- •Panel B: Healthy Participants:
- •History of clinically significant endocrine, GI, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases, other than hypercholesterolemia
研究组 & 干预措施
Panel A: Severe Renal Impairment
Participants with severe renal impairment receive enlicitide once daily (QD) for 28 days.
干预措施: Enlicitide (Drug)
Panel B: Healthy
Healthy participants receive enlicitide QD for 28 days.
干预措施: Enlicitide (Drug)
结局指标
主要结局
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 on Day 28
AUC0-24 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 24 hours post dose on Day 28
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 24 hours post dose on Day 28
Tmax 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 24 hours post dose on Day 28
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 24 hours post dose on Day 28
Vz/F of enlicitide in plasma will be determined.
Number of participants who experience one or more adverse events (AEs)
时间窗: Up to approximately 42 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
Number of participants who discontinue study intervention due to an AE
时间窗: Up to approximately 28 days
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention.
次要结局
未报告次要终点