NCT07137689已完成1 期
Pharmacokinetics of LY3537982 Following a Single Dose in Participants With Renal Impairment Compared With Participants With Normal Renal Function
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Pharmacokinetics: Maximum Concentration (Cmax) of LY3537982
研究概览
简要总结
The purpose of this study is to help determine the right dose of LY3537982 in participants with kidney problems, particularly those with severe kidney problems. The study will last about 43 days for each participant.
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) within the range 19.0 to 42.0 kilograms per square meter (kg/m²), inclusive.
- •Participants Assigned Male at Birth (AMAB) who agree to follow contraception guidance or participants AFAB who are individuals of childbearing potential (INOCBP).
- •Severe renal impairment: Have eGFR determined by CKD-EPI of less than 30 mL/min and not requiring dialysis.
- •Moderate renal impairment: Have eGFR determined by CKD-EPI of greater than or equal to 30 mL/min and less than 60 mL/min.
- •Are not currently or have not previously been on hemodialysis, including peritoneal dialysis.
- •Have acceptable blood pressure as defined by systolic blood pressure less than 160 mmHg and diastolic blood pressure less than 95 mmHg, as well as acceptable pulse rate as defined by no less than 50 bpm and no greater than 100 bpm
排除标准
- •Have history of chronic liver disease, or any evidence for hepatic impairments, or
- •* ALT or AST greater than 2.5 × ULN without any increase in TBL or * TBL greater than 1.5 × ULN without any increase in aminotransferase.
- •Have a current, functional renal transplant. Non-functional renal allografts may be allowed if failure has been greater than 1 year and no longer on immunosuppressive therapies.
- •Diagnosed and/or treated malignancy within 5 years prior to screening with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, and curatively resected in situ carcinoma of the cervix
- •Have known allergies to LY3537982, related compounds or any components of the formulation, or a history of significant atopy.
- •Have previously completed or withdrawn from this study or any other study investigating LY
- •Have participated, within the last 30 days, in a clinical study involving an investigational product. If the previous investigational product has a long half-life, 5 half-lives or 30 days, whichever is longer should have passed, prior to admission
- •Show evidence of HIV infection or positive human HIV antibodies.
- •Have evidence of hepatitis B at screening, that is, positive test for hepatitis B surface antigen, HBV DNA, or both.
- •Have a positive hepatitis C antibody test. Participants with a positive hepatitis C antibody test at screening can be included only if a confirmatory HCV RNA test is negative.
- •Are participants AFAB with a positive pregnancy test or who are lactating. ssion onward, up to 2 g per day of acetaminophen will be allowed at the discretion of the investigator.
研究组 & 干预措施
LY3537982 (Normal renal function)
Experimental
LY3537982 administered orally.
干预措施: LY3537982 (Drug)
LY3537982 (Severe renal impairment)
Experimental
LY3537982 administered orally.
干预措施: LY3537982 (Drug)
LY3537982 (Moderate renal impairment)
Experimental
LY3537982 administered orally.
干预措施: LY3537982 (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Concentration (Cmax) of LY3537982
时间窗: Day 1, Predose up to Day 5 Postdose
Pharmacokinetics: Area Under the Concentration Verses Time Curve from Time Zero to Infinity (AUC[0-∞]) of LY3537982
时间窗: Day 1, Predose up to Day 5 Postdose
Pharmacokinetics: Area Under the Concentrations Verses Time Curve from Time Zero to Time t (AUC(0-tlast) of LY3537982
时间窗: Day 1, Predose up to Day 5 Postdose
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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