Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2026-01-01 @ 8:05 AM
Study NCT ID:
NCT05368935
Status:
COMPLETED
Last Update Posted:
2022-10-28
First Post:
2022-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}], 'ancestors': [{'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C041747', 'term': 'nitazoxanide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-25', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-27', 'studyFirstSubmitDate': '2022-04-12', 'studyFirstSubmitQcDate': '2022-05-06', 'lastUpdatePostDateStruct': {'date': '2022-10-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': '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', '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'}, {'measure': 'Area under the plasma concentration time curve (AUC) from time zero to the time of the last quantifiable concentration (AUC0-t)', 'timeFrame': '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', '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'}, {'measure': 'AUC from time zero to 12h (AUC0-12)', 'timeFrame': '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', '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'}], 'secondaryOutcomes': [{'measure': 'Time of the maximum observed plasma concentration (Tmax) for NTZ and its major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'Apparent plasma terminal elimination half-life (t1/2) for the NTZ and its major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'Unbound fraction in plasma defined as total concentration/unbound concentration (fu) for the NTZ and its major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'Area under the plasma concentration-time curve from time zero to infinity (extrapolated) (AUC0-∞) for the NTZ and its major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'Trough concentration (Ctrough) for the NTZ and its major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'Cmax for the NTZ major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'AUC0-12 for the NTZ major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'AUC0-t for the NTZ major active metabolite', 'timeFrame': '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', 'description': 'Plasma pharmacokinetics'}, {'measure': 'Amount of drug excreted in urine over the time interval between t1 and t2 (Aet1-t2) for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Urine pharmacokinetics'}, {'measure': 'Cumulative amount of drug excreted in urine from time zero until and up to infinity (Ae0-∞) for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Urine pharmacokinetics'}, {'measure': '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', 'timeFrame': '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', 'description': 'Urine pharmacokinetics'}, {'measure': 'Percentage of dose excreted in urine over the time interval between t1 and t2 (Fet1-t2) for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Urine pharmacokinetics'}, {'measure': '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', 'timeFrame': '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', 'description': 'Urine pharmacokinetics'}, {'measure': 'Renal clearance (CLR) for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Urine pharmacokinetics'}, {'measure': 'Cmax after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'AUC0-12 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'AUC0-t after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'AUC0-∞ after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'Tmax after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 't1/2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'Aet1-t2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': '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', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'Fet1-t2 after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': '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', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}, {'measure': 'CLR after the single oral administration of NTZ 500 mg for the NTZ major active metabolites', 'timeFrame': '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', 'description': 'Plasma and urine pharmacokinetics'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Healthy Volunteer', 'Renal Disease', 'Kidney Disease', 'Renal Impairment', 'Antiparasitic', 'Antiprotozoal'], 'conditions': ['Renal Impairment', 'Renal Disease', 'Kidney Disease']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to evaluate the major Nitazoxanide (NTZ) active metabolite in adult participants with renal impairment and healthy adults.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Males or females, between 18 and 80 years of age, inclusive\n2. 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\n3. 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\n4. Matched to subjects with mild, moderate and/or severe renal impairment in age (± 15 years), BMI (± 20%) and sex\n5. The diagnosis of renal impairment has been stable, without significant change in overall disease status in the last 3 months prior to screening\n\nOther protocol-defined inclusion criteria may apply\n\nExclusion Criteria:\n\n1. Positive serum pregnancy test at screening or positive urine pregnancy test\n2. Having taken NTZ at any time prior to the first study drug administration\n3. History of alcohol abuse within 1 year prior to screening\n4. 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\n5. 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\n6. 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\n7. Strenuous exercise within 72 hours prior to check-in\n8. History of a major surgical procedure within 30 days prior to screening\n9. Presence or history of malignancy within the prior 3 years, with the exception of treated basal cell or squamous cell carcinoma\n10. Poor peripheral venous access\n11. Subjects who are taking warfarin or other highly plasma protein-bound drugs with narrow therapeutic indices\n\nOther protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT05368935', 'briefTitle': 'Nitazoxanide Pharmacokinetic Parameters in Renal Impaired Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genfit'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NTZ-122-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy Control Match (RF ≥ 90 mL/min)', 'description': '500 mg Twice Daily for 7 days', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'EXPERIMENTAL', 'label': 'Mild Renal Impairment (RF ≥ 60 to < 90 mL/min)', 'description': '500 mg Twice Daily for 7 days', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Renal Impairment (RF ≥ 30 to < 60 mL/min)', 'description': '500 mg Twice Daily for 7 days', 'interventionNames': ['Drug: Nitazoxanide']}, {'type': 'EXPERIMENTAL', 'label': 'Severe Renal Impairment (RF < 30 mL/min and not on dialysis)', 'description': '500 mg Twice Daily for 7 days', 'interventionNames': ['Drug: Nitazoxanide']}], 'interventions': [{'name': 'Nitazoxanide', 'type': 'DRUG', 'otherNames': ['NTZ'], 'description': '500 mg Twice Daily for 7 days', 'armGroupLabels': ['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)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33014', 'city': 'Miami Lakes', 'state': 'Florida', 'country': 'United States', 'facility': 'Panax Clinical Research', 'geoPoint': {'lat': 25.90871, 'lon': -80.30866}}, {'zip': '32802', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Carol Addy, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Genfit'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genfit', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}