NCT05368935

Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

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 Mild, Moderate, and Severe Renal Impairment and Adult Healthy Control Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Genfit · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

This study is being conducted to assess the pharmacokinetics of the major Nitazoxanide active metabolite as well as the safety and tolerability in renal impaired (mild, moderate and severe) and healthy matched control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days.

Conditions

• Renal Impairment
• Renal Disease
• Kidney Disease

Interventions

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

Timeline

• Start date: 2022-04-25
• Primary completion: 2022-09-04
• Completion: 2022-09-09
• First posted: 2022-05-10
• Last updated: 2022-10-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study