A Phase 1, Open-label, Single Arm Study to Evaluate Pharmacokinetics, Safety, and Tolerability of Saroglitazar Magnesium Dosed on Alternate Days in Subjects Having Moderate Hepatic Impairment With Cirrhosis Due to Cholestatic Liver Disease

Zydus Therapeutics Inc.2 个研究点分布在 1 个国家目标入组 6 人开始时间: 2025年8月5日最近更新: 2026年9月14日

干预措施

试验速览

阶段: 1 期
状态: 招募中
发起方: Zydus Therapeutics Inc.
入组人数: 6
试验地点: 2
主要终点: Pharmacokinetics of Saroglitazar: Cmax

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Evaluating Pharmacokinetic and safety of Saroglitazar Magnesium 1 mg when dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease

详细描述

A phase 1, open-label, single arm study to evaluate pharmacokinetics, safety, and tolerability of Saroglitazar Magnesium dosed on alternate days in subjects having moderate hepatic impairment with cirrhosis due to cholestatic liver disease

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 80 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Male and/or female aged 18 to 80 years (both inclusive) at the time of signing the ICF.
•Body mass index within the range 18.0 to 48.0 kg/m2 (inclusive) at screening.
•Ability to swallow and retain oral medication.
•Subjects having documented history of hepatic impairment with cirrhosis due to cholestatic liver disease having Child-Pugh Turcotte score 7 to
•If the hepatic impairment classification for the subject is not the same at screening and Day -1, enrolment of the subject into a hepatic category group will be at the discretion of the investigator.
•Laboratory test values must be clinically acceptable to the investigator and meet all the following parameters at screening:
•Alkaline Phosphatase > upper limit of normal Alanine aminotransferase/Aspartate aminotransferase value ≤ 10 × upper limit of normal Absolute neutrophil count ≥ 750/mm3 Platelets ≥ 25,000/mm3 Hemoglobin ≥ 8 g/dL α-fetoprotein <50 ng/mL or 50-80 ng/mL with negative imaging study (Ultrasound [US], computed tomography scan [CT], Magnetic Resonance Imaging [MRI]). Imaging study that excluded presence of liver cancer (US in the preceding 6 months and CT or MRI in the preceding 1 year)
•Must provide written informed consent and agree to comply with the trial protocol.

排除标准

•Any significant or unstable medical condition or other instability that would prevent the subject from participating in the study as determined by the investigator
•History of malignancy of any type in the last 3 years of screening, with the exception of the following: in situ cervical or breast cancer or surgically excised non-melanoma skin cancers (i.e., basal cell or squamous cell carcinoma).
•History of stomach or intestinal surgery or resection within 6 months of screening that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy, cholecystectomy, and hernia repair will be allowed).
•The history of any significant drug allergy (such as anaphylaxis) deemed clinically relevant by the investigator.
•Any major surgery within 3 months of screening.
•Donation of blood or blood products within 3 months of screening.
•Active infectious disease requiring systemic antibiotic, antifungal, or antiviral treatment or symptoms of active infectious disease within 2 weeks of screening.
•Receiving or has received any investigational drug within 30 days or 5 half-lives (whichever is longer), before receiving Saroglitazar Magnesium.
•Estimated glomerular filtration rate (<45 mL/min/1.73 m2 by CKD-EPI 2021 formula at screening.
•Any individual with poor peripheral venous access.
•Receipt of blood products within 1 month of check in.
•Human immunodeficiency virus type 1 antibody positive at screening.
•Other known causes of liver disease, such as non-alcoholic steatohepatitis , alcoholic steatohepatitis, autoimmune hepatitis, or acute or chronic viral hepatitis (including Hepatitis B and C) as determined by the investigator and subject's medical records.
•Subjects who have had a change in hepatic disease status within 30 days of screening, as documented by the subject's medical history and deemed clinically significant by the investigator.
•Subjects having - History of gastrointestinal bleeding within 1 month of screening. Current functioning organ transplant. Evidence of severe ascites requiring frequent paracentesis in the opinion of the investigator.
•Pregnancy-related exclusions, including:
•Pregnant/lactating female (including positive pregnancy test at screening) Pregnancy should be avoided by male and female subjects either by true abstinence or the use of an acceptable effective contraceptive measures for the duration of the study and for at least 1 month after the end of the study treatment.

研究组 & 干预措施

Saroglitazar Magnesium 1 mg

Experimental

Saroglitazar Magnesium 1 mg tablet orally administered on alternate days in the morning before breakfast without food, for the duration of treatment (29 days)

干预措施: Saroglitazar Magnesium 1 mg (Drug)