Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-25

Study Completion Date

2022-09-09

Brief Summary

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

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Detailed Description

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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

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Renal Impairment Renal Disease Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Control Match (RF ≥ 90 mL/min)

500 mg Twice Daily for 7 days

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

500 mg Twice Daily for 7 days

Mild Renal Impairment (RF ≥ 60 to < 90 mL/min)

500 mg Twice Daily for 7 days

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

500 mg Twice Daily for 7 days

Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min)

500 mg Twice Daily for 7 days

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

500 mg Twice Daily for 7 days

Severe Renal Impairment (RF < 30 mL/min and not on dialysis)

500 mg Twice Daily for 7 days

Group Type EXPERIMENTAL

Nitazoxanide

Intervention Type DRUG

500 mg Twice Daily for 7 days

Interventions

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Nitazoxanide

500 mg Twice Daily for 7 days

Intervention Type DRUG

Other Intervention Names

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NTZ

Eligibility Criteria

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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
11. Subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes