Pharmacokinetics of LY3819469 Following Subcutaneous Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 4
- 主要终点
- Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469
研究概览
简要总结
The main purpose of this study is to assess the amount of study drug (LY3819469) that reaches the bloodstream and the time it takes for the body to get rid of it when given to participants with renal (kidney) impairment compared to participants with normal renal function. The safety and tolerability of LY3819469 will also be evaluated in these participants. The study will last up to 17 weeks including screening period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²)
- •Men who agree to use highly effective or effective methods of contraception and women not of childbearing potential (WNOCBP) may participate in this trial
- •Participants with Normal Renal Function:
- •Have estimated glomerular filtration rate (eGFR) determined by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) greater than or equal to 90 milliliter per minute (mL/min)
- •Participants with Renal Impairment:
- •Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis
- •ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing
排除标准
- •Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition
- •Have any abnormality in the 12-lead electrocardiogram (ECG)
- •Hemoglobin less than 8 grams per deciliter (g/dL) and clinically significant anemia symptoms
- •Have known allergies to LY3819469, related compounds or any components of the formulation, or a history of significant atopy
- •Have participated in any Lp(a) siRNA therapeutic clinical trial within the last 1 year
研究组 & 干预措施
LY3819469 (Control)
LY3819469 administered subcutaneously (SC) to participants with normal renal function
干预措施: LY3819469 (Drug)
LY3819469 (Severe Renal Impairment)
LY3819469 administered SC to participants with severe renal impairment
干预措施: LY3819469 (Drug)
LY3819469 (End-Stage Renal Disease)
LY3819469 administered SC to participants with end-stage renal disease (ESRD)
干预措施: LY3819469 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3819469
时间窗: Predose up to 85 days postdose
PK: AUC0-tlast of LY3819469
PK: Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3819469
时间窗: Predose up to 85 days postdose
PK: AUC0-∞ of LY3819469
PK: Maximum observed concentration (Cmax) of LY3819469
时间窗: Predose up to 85 days postdose
PK: Cmax of LY3819469
次要结局
未报告次要终点