Pharmacokinetics of LY3473329 Following Oral Administration 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
- 48
- 试验地点
- 4
- 主要终点
- Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
研究概览
简要总结
The main purpose of this study is to assess the amount of study drug (LY3473329) 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 LY3473329 will also be evaluated in these participants. The study will last up to 8 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, women of childbearing potential (WOCP) who agree to use highly effective or effective methods of contraception, and women not of childbearing potential (WNOCBP) may participate in this trial
- •Have clinical laboratory test results within the normal reference range for the population
排除标准
- •Have a history or presence of an underlying disease, or surgical, physical, medical, or psychiatric condition that, in the opinion of the investigator, would potentially affect participant safety within the study
- •Have any abnormality in the 12-lead electrocardiogram (ECG), blood pressure and/or pulse rate that, in the opinion of the investigator, increases the risks associated with participating in the study
- •Hemoglobin less than 8 grams/deciliter (g/dL) and/or clinically significant anemia symptoms
- •Have an average weekly alcohol intake that exceeds 21 units per week for males and 14 units per week for females or males older than 65 years of age
- •Smoke more than 10 cigarettes per day or the equivalent
- •Have donated blood of more than 500 milliliter (mL) within 3 months prior to screening
研究组 & 干预措施
LY3473329 (Control)
LY3473329 administered orally to participants with normal renal function
干预措施: LY3473329 (Drug)
LY3473329 (Mild Renal Impairment)
LY3473329 administered orally to participants with mild renal impairment
干预措施: LY3473329 (Drug)
LY3473329 (Moderate Renal Impairment)
LY3473329 administered orally to participants with moderate renal impairment
干预措施: LY3473329 (Drug)
LY3473329 (Severe Renal Impairment)
LY3473329 administered orally to participants with severe renal impairment
干预措施: LY3473329 (Drug)
LY3473329 (End-Stage Renal Disease)
LY3473329 administered orally to participants with end-stage renal disease
干预措施: LY3473329 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3473329
时间窗: Predose up to 34 days postdose
PK: AUC0-∞ of LY3473329
PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3473329
时间窗: Predose up to 34 days postdose
PK: AUC0-tlast of LY3473329
PK: Maximum observed concentration (Cmax) of LY3473329
时间窗: Predose up to 34 days postdose
PK: Cmax of LY3473329
次要结局
未报告次要终点