NCT05116826

Nitazoxanide Pharmacokinetic Parameters in Hepatic Impaired Patients

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
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Moderate Hepatic Impairment
• Severe Hepatic Impairment
• Liver Diseases

Interventions

Type	Name	Description
DRUG	Nitazoxanide	500 mg Twice Daily for 7 days

Timeline

• Start date: 2021-11-05
• Primary completion: 2022-04-08
• Completion: 2022-04-13
• First posted: 2021-11-11
• Last updated: 2022-10-14

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study