CLINICAL TRIAL: PHASE I STUDY OF SILYMARIN IN CHRONIC HEPATITIS C OR FATTY LIVER

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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.