NCT07401862招募中1 期
A Phase 1, Multicenter, Open-Label, Parallel-Design Study to Assess the Pharmacokinetics and Tolerability of a Single Subcutaneous Dose of Eloralintide (LY3841136) in Participants With Mild, Moderate, or Severe Hepatic Impairment and Participants With Normal Hepatic Function
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136
研究概览
简要总结
The main purpose of this study is to evaluate how a medicine, LY3841136, works in participants with different levels of liver damage and in participants with healthy liver. The researchers want to see how the medicine is absorbed and used by the body, and if it causes any side effects, in participants with mild, moderate, or severe liver damage, as well as in participants with normal liver function.
For each participant, the study will last about 14 weeks, which will include a stay at the clinical research unit for 5 nights.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 weight of 55 kilograms (kg) or more and body mass index between 19.0 and 40.0 kilograms per square meter (kg/m²), inclusive
- •Are healthy as determined by medical history, physical examination, and other screening procedures, with clinically normal hepatic function at screening
- •Groups 2 through 4
- •Have hepatic impairment classified as Child-Pugh score A, B, or C (mild, moderate, or severe impairment who are considered acceptable for participation in this study by the investigator. Participants must have a diagnosis of chronic hepatic impairment of greater than 6 months per physician diagnosis and standard-of-care practice, with no clinically significant changes in the opinion of the investigator within 15 days prior to screening
- •Participants with hepatic impairment may have stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct
排除标准
- •Have a history or presence of chronic or acute pancreatitis or elevation in serum amylase or lipase greater than 1.5 × upper limit of normal (ULN)
- •Are pregnant or intend to become pregnant or to breastfeed during the study
- •Have liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 1.5 × ULN or total bilirubin (TBL) greater than 1.5 × ULN at screening
- •Have a current infection with hepatitis B virus (HBV), that is,
- •if hepatitis B surface antigen (HBsAg) is positive, the participant is excluded, or
- •if HBsAg is negative and anti-Hepatitis B core antibody (HBc) is positive, further testing for HBV deoxyribonucleic acid (DNA) is required, and
- •if the screening HBV DNA is positive, the participant is excluded
- •Have a current infection with hepatitis C virus (HCV), that is,
- •if anti-HCV is positive, a test for circulating HCV ribonucleic acid (RNA) is required, and
- •if HCV RNA test is positive, the participant is excluded
- •Groups 2, 3, and 4
- •Have presence of active portal shunt or transjugular intrahepatic portosystemic shunt
- •Require paracentesis more often than 2 times per month or are expected to require paracentesis during the study
- •Have evidence of spontaneous bacterial peritonitis within 6 months of screening
- •Have had variceal bleeding within 3 months of screening. If the participant has undergone a successful banding procedure, they may participate in the study providing at least 1 month has passed after the banding procedure at the time of screening
- •Show presence of hepatocellular carcinoma
- •Have hepatic encephalopathy of Grade 2 or higher
- •Have TBL greater than 15 milligrams per deciliter (mg/dL)
- •Have ALT greater than or equal to 6 × ULN
研究组 & 干预措施
Eloralintide (Moderate Hepatic Impairment)
Experimental
Eloralintide administered SC
干预措施: LY3841136 (Drug)
Eloralintide (Normal Hepatic Function)
Experimental
Eloralintide administered subcutaneously (SC)
干预措施: LY3841136 (Drug)
Eloralintide (Mild Hepatic Impairment)
Experimental
Eloralintide administered SC
干预措施: LY3841136 (Drug)
Eloralintide (Severe Hepatic Impairment)
Experimental
Eloralintide administered SC
干预措施: LY3841136 (Drug)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Zero to Infinity AUC(0-∞) of LY3841136
时间窗: Predose on Day 1 up to Day 71
PK: Maximum Observed Drug Concentration (Cmax) of LY3841136
时间窗: Predose on Day 1 up to Day 71
次要结局
未报告次要终点
研究者
研究点 (3)
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