A Parallel-Group, Single-Dose, Phase 1, Open-Label Study to Investigate the Pharmacokinetics of LY3437943 in Participants With Hepatic Impairment Compared With Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 5
- 主要终点
- PK: Maximum observed concentration (Cmax) of LY3437943
研究概览
简要总结
The main purpose of this study is to measure how much of LY3437943 gets into the bloodstream and how long it takes the body to eliminate it in participants with mild, moderate and severe impaired liver function compared to healthy participants with normal liver function. The safety and tolerability of LY3437943 will also be evaluated. The study may last up to 9 weeks for each participant including the 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
- •All Participants:
- •Have a body mass index within the range 19.0 to 42.0 kilograms per meter squared (kg/m²), inclusive
- •Healthy or various degrees of hepatic impairment depending on the study group
排除标准
- •Participants with hepatic impairment:
- •Have or are anticipating an organ transplant within the next 6 months
- •Requires needle evacuation of ascites fluid more than 2 times per month
- •Have had variceal bleeding within 3 months of check-in, unless the participant has undergone a successful banding procedure; in that case, may check-in from 1 month after the banding procedure
研究组 & 干预措施
LY3437943 (Moderate Hepatic Impairment)
LY3437943 administered SC.
干预措施: LY3437943 (Drug)
LY3437943 (Mild Hepatic Impairment)
LY3437943 administered SC.
干预措施: LY3437943 (Drug)
LY3437943 (Normal Hepatic Function)
LY3437943 administered subcutaneously (SC).
干预措施: LY3437943 (Drug)
LY3437943 (Severe Hepatic Impairment)
LY3437943 administered SC.
干预措施: LY3437943 (Drug)
结局指标
主要结局
PK: Maximum observed concentration (Cmax) of LY3437943
时间窗: Predose up to 30 days postdose
PK: Cmax of LY3437943
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3437943
时间窗: Predose up to 30 days postdose
PK: AUC0-∞ of LY3437943
次要结局
未报告次要终点