Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients

Liver Diseases Clinical Trial

Official title: An Open-label, Phase 1, Multiple-dose Study to Evaluate the Pharmacokinetics of Nitazoxanide 500 mg Twice Daily for 7 Days in Adult Subjects With Moderate and Severe Hepatic Impairment and Adult Healthy Control Subjects

Status Completed

Clinical Trial Summary

This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with hepatic impairment and healthy adults.

Clinical Trial Description

This study is being conducted to assess the effect of hepatic impairment on the pharmacokinetics of the major Nitazoxanide active metabolite in hepatic impaired (moderate and severe according to Child-Pugh categories) and healthy control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days. ;

Related Conditions & MeSH terms

• Liver Diseases
• Moderate Hepatic Impairment
• Severe Hepatic Impairment

• NCT number: NCT05116826
• Study type: Interventional
• Source: Genfit
• Status: Completed
• Phase: Phase 1
• Start date: November 5, 2021
• Completion date: April 13, 2022