Status:
COMPLETED
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
Lead Sponsor:
Genfit
Conditions:
Renal Impairment
Renal Disease
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief 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 health...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 25 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT05368935
Start Date
April 25 2022
End Date
September 9 2022
Last Update
October 28 2022
Active Locations (2)
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1
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32802