Pharmacokinetics of LY3314814 in Subjects With Hepatic Impairment
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 4
- 主要终点
- Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
研究概览
简要总结
The purpose of the study is to determine whether LY3314814 can be safely prescribed in participants with liver impairment without a dose adjustment. Participants will be on study for 11 days with follow-up about 7 days afterward.
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 (BMI) of 18 to 40 kilogram per meter square (kg/m²), inclusive, at the time of screening
排除标准
- •Have a history of or current significant ophthalmic disease, particularly any eye problem involving the retina
- •Have moderate or severe vitiligo or any other clinically significant disorder of skin or hair pigmentation
- •Have acute unstable neuropsychiatric disease
- •Have active or uncontrolled neurologic disease, or clinically significant head injury
研究组 & 干预措施
LY3314814 Control
LY3314814 administered orally to participants with normal hepatic function
干预措施: LY3314814 (Drug)
LY3314814 Mild
LY3314814 administered orally to participants with mild hepatic impairment
干预措施: LY3314814 (Drug)
LY3314814 Moderate
LY3314814 administered orally to participants with moderate hepatic impairment
干预措施: LY3314814 (Drug)
LY3314814 Severe
LY3314814 administered orally to participants with severe hepatic impairment
干预措施: LY3314814 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of LY3314814
时间窗: Baseline through 240 hours after the administration of study drug
PK: AUC(0-∞) of LY3314814
PK: Maximum Observed Drug Concentration (Cmax) of LY3314814
时间窗: Baseline through 240 hours after the administration of study drug
PK: Cmax of LY3314814
次要结局
未报告次要终点