Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

Completed · Phase 1

Conditions studied: Renal Impairment, Renal Disease, Kidney Disease

In brief

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

Key facts

Study ID

NCT05368935

Run by

Genfit

People needed

77

Starts

2022-04-25

Expected to finish

2022-09-09

Last updated by the study team

2022-10-28

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Males or females, between 18 and 80 years of age, inclusive
• 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
• 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
• Matched to subjects with mild, moderate and/or severe renal impairment in age (± 15 years), BMI (± 20%) and sex
• The diagnosis of renal impairment has been stable, without significant change in overall disease status in the last 3 months prior to screening
• Other protocol-defined inclusion criteria may apply

You may not qualify if…

• Positive serum pregnancy test at screening or positive urine pregnancy test
• Having taken NTZ at any time prior to the first study drug administration
• History of alcohol abuse within 1 year prior to screening
• 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
• 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
• 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
• Strenuous exercise within 72 hours prior to check-in
• History of a major surgical procedure within 30 days prior to screening
• Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma
• Poor peripheral venous access
• Subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices
• Other protocol-defined exclusion criteria may apply

Where it is running

• Panax Clinical Research — Miami Lakes, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States

Full record on ClinicalTrials.gov

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