PHASE I STUDY OF SILYMARIN IN CHRONIC HEPATITIS C OR FATTY LIVER DISEASE

水飞蓟素治疗慢性丙型肝炎或脂肪肝疾病的 I 期研究

• 批准号: 7606980
• 负责人: Nezam Hassan Afdahl
• 金额: $ 1.29万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-04-01 至 2008-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7606980
• 关键词: American; Biological Availability; Chronic Hepatitis; Chronic Hepatitis C; Computer Retrieval of Information on Scientific Projects Database; Cross-Over Studies; Daily; Dose; Double-Blind Method; Drug Kinetics; Fatty Liver; Funding; Grant; Hepatitis C virus; Institution; Isomerism; Legalon; Liver diseases; Oral; Patients; Phase; Phase I Clinical Trials; Placebo Control; Randomized; Relative (related person); Research; Research Personnel; Resources; Safety; Silymarin; Source; Time; United States National Institutes of Health; Upper arm; design; non-alcoholic fatty liver

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This phase 1 study is designed to evaluate the safety, tolerability and pharmacokinetics of orally administered silymarin in non-cirrhotic subjects with chronic hepatitis C and non-alcoholic fatty liver disease. The primary objective is to identify silymarin exposure levels in patients with non-cirrhotic liver disease that are safe and to determine if exposures are dose-proportional, as well as to determine the pharmacokinetics for the six principal silymarin isomers, after single and multiple doses of Legalon administered orally up to 700 mg three times daily in patients with either HCV or NAFLD. The secondary objectives are to determine the effect of a typical 800 kcal American meal on the relative oral bioavailability of the six principal isomers of silymarin following a single Legalon dose of 280 mg in patients with HCV. This is a multi-center, randomized, double-blind, placebo-controlled, parallel group dose-escalation study that includes a crossover study arm designed to evaluate the effect of a high calorie meal on the bioavailability of Legalon.

该子项目是利用该技术的众多研究子项目之一 资源由 NIH/NCRR 资助的中心拨款提供。子项目和 研究者 (PI) 可能已从 NIH 的另一个来源获得主要资金， 因此可以在其他 CRISP 条目中表示。列出的机构是 对于中心来说，它不一定是研究者的机构。 这项一期研究旨在评估口服水飞蓟素在患有慢性丙型肝炎和非酒精性脂肪肝的非肝硬化受试者中的安全性、耐受性和药代动力学。主要目的是确定非肝硬化肝病患者中安全的水飞蓟素暴露水平，并确定暴露是否与剂量成比例，以及确定 HCV 或 NAFLD 患者每日 3 次口服单剂量和多剂量 Legalon（每次 700 mg）后六种主要水飞蓟素异构体的药代动力学。 次要目标是确定 HCV 患者单次服用 280 mg 的 Legalon 后，典型的 800 kcal 美式膳食对水飞蓟素六种主要异构体的相对口服生物利用度的影响。 这是一项多中心、随机、双盲、安慰剂对照、平行组剂量递增研究，其中包括交叉研究组，旨在评估高热量膳食对 Legalon 生物利用度的影响。