Loading clinical trials...

COMPLETEDPHASE1

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

NCT05368935•Genfit

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Males or females, between 18 and 80 years of age, inclusive
•2. With a minimum body weight of ≥ 50.0 kg for males and ≥ 45.0 kg for females and within a BMI range of 18.0 to 40.0 kg/m\^2, inclusive
•3. Females participating in this study must be of non-childbearing potential or must be using highly effective contraception for the full duration of the study
•4. Matched to subjects with mild, moderate and/or severe renal impairment in age (± 15 years), BMI (± 20%) and sex
•5. The diagnosis of renal impairment has been stable, without significant change in overall disease status in the last 3 months prior to screening

Exclusion Criteria

•1. Positive serum pregnancy test at screening or positive urine pregnancy test
•2. Having taken NTZ at any time prior to the first study drug administration
•3. History of alcohol abuse within 1 year prior to screening
•4. History of drug abuse within 1 year prior to screening or recreational use of soft drugs within 1 month or hard drugs within 3 months prior to screening
•5. Excessive consumption of xanthine-based drinks (\> 4 cups or glasses per day), food or beverages containing xanthine derivatives or xanthine-based compounds, 48 hours prior to the first dosing
•6. Donation of plasma within 7 days prior to dosing or donation or loss of 500 mL or more of whole blood within 8 weeks prior to the first dosing
•7. Strenuous exercise within 72 hours prior to check-in
•8. History of a major surgical procedure within 30 days prior to screening
•9. Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma
•10. Poor peripheral venous access
+1 more criteria

Locations (2)

Panax Clinical Research

Miami Lakes, Florida, United States

Orlando Clinical Research Center

Orlando, Florida, United States

Key Dates

Start Date

April 25, 2022

Primary Completion Date

September 4, 2022

Completion Date

September 9, 2022

Last Updated

October 28, 2022

Enrollment

ACTUAL participants

Conditions

Renal ImpairmentRenal DiseaseKidney Disease

Interventions

Nitazoxanide

DRUG

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

NCT07241390

Atherosclerosis Cardiovascular DiseaseChronic Kidney Disease

View study

RECRUITINGNA

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

NCT04634916

Kidney Disease, End-StageEnd-stage Renal Disease+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 28, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

Inclusion Criteria

Exclusion Criteria

A Study of Orforglipron (LY3502970) on Cardiovascular Outcomes in Adults With Atherosclerotic Cardiovascular Disease and/or Chronic Kidney Disease (ATTAIN-Outcomes)

Post-market Surveillance Study of the BD® WavelinQ™ EndoAVF System

A Study to Test Whether Vicadrostat in Combination With Empagliflozin Helps People With Chronic Kidney Disease

Study to Assess the Effects of Angiopoietin-like Protein 3 (ANGPTL3) Inhibition in Adult Participants With Diabetic Kidney Disease

A Research Study Comparing How Well Different Doses of the Medicine NNC0519-0130 Can Reduce Kidney Damage in People Living With Chronic Kidney Disease

Metabolic Impacts of Ren-Nu: A Dietary Program for Polycystic Kidney Disease