NCT07358546招募中1 期
A Phase 1, Open-label, Single-dose Study to Evaluate the Pharmacokinetics and Safety of Efimosfermin Alfa in Adults With Varying Degrees of Hepatic Impairment Due to Steatotic Liver Disease
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
研究概览
简要总结
This study is designed to study the pharmacokinetic (PK) and safety profiles of a single dose of efimosfermin alfa in participants with varying degrees of Hepatic Impairment (HI) (assessed by Child-Pugh score) due to steatotic liver disease, with and without significant alcohol consumption.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open-label study
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 years and 70 years of age inclusive
- •Body Mass Index (BMI) within the range 23-40 kilogram per square meter (kg/m^2)
- •Male or female participants
- •Participant has liver cirrhosis with a grade of hepatic impairment that can be classified as a discrete Child-Pugh class. Participants must:
- •Have a clinical diagnosis of liver cirrhosis in the participant's medical history corroborated by previous liver biopsy, medical imaging or compatible biochemical profile, and
- •Be classed during Screening as one of the following Child-Pugh classes:
- •Child-Pugh B: Score 7-9 or
- •Child-Pugh C: Score 10-15
- •Chronic (greater than [>] 6 months) HI which is currently stable (no acute episodes of illness within the previous 1 month prior to Screening (Visit 1) due to deterioration in hepatic function). Participants must also remain stable throughout the Screening period. Assessment of the stability of the participant's hepatic function will be determined by the investigator.
排除标准
- •History of extrahepatic disorders possibly related to etiology of cirrhosis.
- •History of cryoglobulinemia.
- •Participants with Grade 3 ascites or refractory ascites.
- •Participants with refractory encephalopathy or significant central nervous system disease
- •History of gastric or esophageal variceal bleeding within the past 6 months and for which varices have not been adequately treated with medication and/or surgical procedures.
- •Other primary causes of liver disease. Steatotic liver disease must be the primary cause of liver disease.
- •Clinically significant abnormalities affecting physical health in medical history, or on physical examination, that could interfere with or for which treatment could interfere with the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study.
- •Current, or history of known hepatocellular carcinoma (HCC).
- •Participants with transjugular intrahepatic portosystemic shunt (TIPS) placement.
- •Presence of hepatopulmonary or hepatorenal syndrome.
- •Presence of primarily cholestatic liver diseases.
- •Evidence of symptomatic or complicated cholecystitis.
- •History of pancreatic injury, pancreatitis, or other pancreatic disease.
- •History of liver transplantation, or active on the liver transplant waiting list.
- •Participants with signs of active infection
- •History of adrenal gland disease or using treatment that affects the hypothalamic-pituitary-adrenal axis.
- •History of significant bone disease such as osteoporosis
- •Psychosocial features that, in the opinion of the investigator, increase the likelihood of loss to follow-up.
- •History or presence of drug abuse.
- •Use of other investigational drugs at the time of screening, or within 5 half-lives or 30 days prior to study intervention, whichever was longer; or longer if required by local regulations
- •Have previously taken efimosfermin alfa
- •Participants with Alanine Aminotransferase (ALT) value >3 times (x) upper limit of normal (ULN)
- •Participants with Aspartate aminotransferase (AST) value >=300 Units/Liter.
- •Participants with estimated glomerular filtration rate (eGFR) (Chronic Kidney Disease Epidemiology [CKD-Epi] 2021) <45 milliliter/minute/1.73 square meter (mL/min/1.73m^2).
- •Average of triplicate QT interval corrected for heart rate using Fridericia formula (QTcF) >480 milliseconds (msec) (for male and female participants) at Screening
- •For participants in the MASH with alcohol category, significant risk of withdrawal symptoms.
研究组 & 干预措施
Efimosfermin alfa in severe hepatic impairment participants due to MASH regardless of alcohol use
Experimental
All participants will receive efimosfermin alfa. Participants will have severe hepatic impairment (Child-Pugh C) due to MASH with any typical daily alcohol consumption.
干预措施: Efimosfermin alfa (Drug)
Efimosfermin alfa in participants with moderate hepatic impairment due to MASH without alcohol
Experimental
All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to Metabolic Dysfunction-Associated Steatohepatitis (MASH) with typical alcohol consumption threshold in the 3 months prior to Screening of less than (<) 5 standard drinks on any day and <15 standard drinks per week for men; or <4 standard drinks on any day and <8 standard drinks per week for women.
干预措施: Efimosfermin alfa (Drug)
Efimosfermin alfa in participants with moderate hepatic impairment due to MASH with alcohol
Experimental
All participants will receive efimosfermin alfa. Participants will have moderate hepatic impairment (Child-Pugh B) due to MASH with typical alcohol consumption threshold in the 3 months prior to Screening of greater than or equal to (>=) 5 standard drinks per day or >=15 standard drinks per week for men; or >= 4 standard drinks per day or >=8 or more drinks per week for women.
干预措施: Efimosfermin alfa (Drug)
结局指标
主要结局
Area under the serum drug concentration versus time curve from time zero to infinity (AUC[0-inf]) of efimosfermin alfa
时间窗: Up to 90 Days
Maximum observed serum drug concentration (Cmax) of efimosfermin alfa
时间窗: Up to 90 Days
次要结局
- Number of participants with clinically significant changes in hematology, chemistry, and urinalysis parameters(Up to 90 Days)
- Number of participants with clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings(Up to 90 Days)
- Number of participants with Adverse Events (AEs), treatment related AEs and serious adverse events (SAEs)(Up to 90 Days)
- Number of participants with Clinically significant changes in hematology, chemistry, and urinalysis parameters(Up to 90 Days)
- Number of participants with Clinically significant changes in Vital signs and 12-lead electrocardiogram (ECG) findings(Up to 90 Days)
- Area under the serum drug concentration versus time curve from time zero to the time of the last quantifiable concentration (AUC[0-t]) of efimosfermin alfa(Up to 90 Days)
- Time to maximum observed serum drug concentration (Tmax) of efimosfermin alfa(Up to 90 Days)
- Apparent terminal phase half-life (t1/2) of efimosfermin alfa(Up to 90 Days)
- Time prior to the first measurable (non-zero) serum concentration (Tlag) of efimosfermin alfa(Up to 90 Days)
- Apparent clearance (CL/F) of efimosfermin alfa(Up to 90 days)
- Apparent terminal phase volume of distribution (Vz/F) of efimosfermin alfa(Up to 90 days)
- Terminal elimination rate constant (Lambda z) of efimosfermin alfa(Up to 90 days)
研究者
研究点 (3)
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