Back to resultsNitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
Primary Purpose
Renal Impairment, Renal Disease, Kidney Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nitazoxanide
Sponsored by
About this trial
This is an interventional basic science trial for Renal Impairment focused on measuring Pharmacokinetics, Healthy Volunteer, Renal Disease, Kidney Disease, Renal Impairment, Antiparasitic, Antiprotozoal
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Sites / Locations
- Panax Clinical Research
- Orlando Clinical Research Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy Control Match (RF ≥ 90 mL/min)
Mild Renal Impairment (RF ≥ 60 to < 90 mL/min)
Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min)
Severe Renal Impairment (RF < 30 mL/min and not on dialysis)
Arm Description
500 mg Twice Daily for 7 days
500 mg Twice Daily for 7 days
500 mg Twice Daily for 7 days
500 mg Twice Daily for 7 days
Outcomes
Primary Outcome Measures
Maximum observed plasma concentration (Cmax)
Plasma pharmacokinetic (PK) parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Area under the plasma concentration time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t)
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
AUC from time zero to 12h (AUC0-12)
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Secondary Outcome Measures
Time of the maximum observed plasma concentration (Tmax) for NTZ and its major active metabolite
Plasma pharmacokinetics
Apparent plasma terminal elimination half-life (t1/2) for the NTZ and its major active metabolite
Plasma pharmacokinetics
Unbound fraction in plasma defined as total concentration/unbound concentration (fu) for the NTZ and its major active metabolite
Plasma pharmacokinetics
Area under the plasma concentration-time curve from time zero to infinity (extrapolated) (AUC0-∞) for the NTZ and its major active metabolite
Plasma pharmacokinetics
Trough concentration (Ctrough) for the NTZ and its major active metabolite
Plasma pharmacokinetics
Cmax for the NTZ major active metabolite
Plasma pharmacokinetics
AUC0-12 for the NTZ major active metabolite
Plasma pharmacokinetics
AUC0-t for the NTZ major active metabolite
Plasma pharmacokinetics
Amount of drug excreted in urine over the time interval between t1 and t2 (Aet1-t2) for the NTZ major active metabolites
Urine pharmacokinetics
Cumulative amount of drug excreted in urine from time zero until and up to infinity (Ae0-∞) for the NTZ major active metabolites
Urine pharmacokinetics
Cumulative amount of drug excreted in urine from time zero until the last measured concentration at time t (Ae0-t) for the NTZ major active metabolites
Urine pharmacokinetics
Percentage of dose excreted in urine over the time interval between t1 and t2 (Fet1-t2) for the NTZ major active metabolites
Urine pharmacokinetics
Cumulative percent of dose excreted in urine from time zero until the last measured concentration at time t (Fe0-t) for the NTZ major active metabolites
Urine pharmacokinetics
Renal clearance (CLR) for the NTZ major active metabolites
Urine pharmacokinetics
Cmax after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
AUC0-12 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
AUC0-t after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
AUC0-∞ after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
Tmax after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
t1/2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
Aet1-t2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
Amount of drug excreted in urine from time zero to 12h (Ae0-12) after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
Fet1-t2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
Cumulative percent of dose excreted in urine from time zero to 12h (Fe0-12) after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
CLR after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Plasma and urine pharmacokinetics
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05368935
Brief Title
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
April 25, 2022 (Actual)
Primary Completion Date
September 4, 2022 (Actual)
Study Completion Date
September 9, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genfit
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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 healthy matched control adults following repeated oral dose administration of NTZ 500 mg twice a day for 7 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment, Renal Disease, Kidney Disease
Keywords
Pharmacokinetics, Healthy Volunteer, Renal Disease, Kidney Disease, Renal Impairment, Antiparasitic, Antiprotozoal
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy Control Match (RF ≥ 90 mL/min)
Arm Type
Experimental
Arm Description
500 mg Twice Daily for 7 days
Arm Title
Mild Renal Impairment (RF ≥ 60 to < 90 mL/min)
Arm Type
Experimental
Arm Description
500 mg Twice Daily for 7 days
Arm Title
Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min)
Arm Type
Experimental
Arm Description
500 mg Twice Daily for 7 days
Arm Title
Severe Renal Impairment (RF < 30 mL/min and not on dialysis)
Arm Type
Experimental
Arm Description
500 mg Twice Daily for 7 days
Intervention Type
Drug
Intervention Name(s)
Nitazoxanide
Other Intervention Name(s)
NTZ
Intervention Description
500 mg Twice Daily for 7 days
Primary Outcome Measure Information:
Title
Maximum observed plasma concentration (Cmax)
Description
Plasma pharmacokinetic (PK) parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24 hours (Day 8); 48 hours (Day 9); 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Area under the plasma concentration time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t)
Description
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24 (Day 8); 48 (Day 9); 72 (Day 10) and 96 (Day 11) hours post-dose
Title
AUC from time zero to 12h (AUC0-12)
Description
Plasma pharmacokinetic parameters of NTZ active metabolite expressed in terms of unbound as well as total concentrations at steady-state in subjects with mild, moderate and severe renal impairment compared to healthy volunteers
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18; 24 hours (Day 8); 48 hours (Day 9); 72 hours (Day 10) and 96 hours (Day 11) post-dose
Secondary Outcome Measure Information:
Title
Time of the maximum observed plasma concentration (Tmax) for NTZ and its major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Apparent plasma terminal elimination half-life (t1/2) for the NTZ and its major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Unbound fraction in plasma defined as total concentration/unbound concentration (fu) for the NTZ and its major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Area under the plasma concentration-time curve from time zero to infinity (extrapolated) (AUC0-∞) for the NTZ and its major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Trough concentration (Ctrough) for the NTZ and its major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Cmax for the NTZ major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
AUC0-12 for the NTZ major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
AUC0-t for the NTZ major active metabolite
Description
Plasma pharmacokinetics
Time Frame
Day 1: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10 and 12 hours post dose; Day 2-6: pre-dose; Day 7: pre-dose; 1; 2; 3; 4; 5; 6; 7; 8; 10; 12; 14; 16; 18 hours; 24 hours (Day 8); 48 hours (Day 9) ; 72 hours (Day 10) and 96 hours (Day 11) post-dose
Title
Amount of drug excreted in urine over the time interval between t1 and t2 (Aet1-t2) for the NTZ major active metabolites
Description
Urine pharmacokinetics
Time Frame
Day (D) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; D7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
Title
Cumulative amount of drug excreted in urine from time zero until and up to infinity (Ae0-∞) for the NTZ major active metabolites
Description
Urine pharmacokinetics
Time Frame
Day (D) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; D7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
Title
Cumulative amount of drug excreted in urine from time zero until the last measured concentration at time t (Ae0-t) for the NTZ major active metabolites
Description
Urine pharmacokinetics
Time Frame
Day (D) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; D7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
Title
Percentage of dose excreted in urine over the time interval between t1 and t2 (Fet1-t2) for the NTZ major active metabolites
Description
Urine pharmacokinetics
Time Frame
Day (D) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; D7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
Title
Cumulative percent of dose excreted in urine from time zero until the last measured concentration at time t (Fe0-t) for the NTZ major active metabolites
Description
Urine pharmacokinetics
Time Frame
Day (D) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; D7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
Title
Renal clearance (CLR) for the NTZ major active metabolites
Description
Urine pharmacokinetics
Time Frame
Day (D) 1: pre-dose, 0-4 hours (h); 4-8 h; and 8-12 h post-morning dose; D7: 0-4 h; 4-8 h; 8-12 h; 12- 24 h; 24-48 h; 48-72 h and 72-96 h post-dose
Title
Cmax after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
AUC0-12 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
AUC0-t after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
AUC0-∞ after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
Tmax after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
t1/2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
Aet1-t2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
Amount of drug excreted in urine from time zero to 12h (Ae0-12) after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
Fet1-t2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
Cumulative percent of dose excreted in urine from time zero to 12h (Fe0-12) after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
Title
CLR after the single oral administration of NTZ 500 mg for the NTZ major active metabolites
Description
Plasma and urine pharmacokinetics
Time Frame
D1:predose;1;2;3;4;5;6;7;8;10;12h post dose; D2-6:predose; D7:predose;1;2;3;4;5;6;7;8;10;12;14;16;18; 24(D8);48(D9);72(D10) and 96(11)h post-dose.Urine:D1 predose; 0-4; 4-8; 8-12 h post morning dose; D7 0-4;4-8;8-12;12- 24;24-48;48-72;72-96h post-dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Addy, MD
Organizational Affiliation
Genfit
Official's Role
Study Director
Facility Information:
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Orlando Clinical Research Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32802
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
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