Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-26 @ 4:34 AM
Study NCT ID:
NCT01239459
Status:
COMPLETED
Last Update Posted:
2012-03-01
First Post:
2010-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'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': 'C527525', 'term': 'teriflunomide'}, {'id': 'D002792', 'term': 'Cholestyramine Resin'}], 'ancestors': [{'id': 'D011137', 'term': 'Polystyrenes'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-28', 'studyFirstSubmitDate': '2010-11-09', 'studyFirstSubmitQcDate': '2010-11-10', 'lastUpdatePostDateStruct': {'date': '2012-03-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters of Teriflunomide determined from plasma concentration (Maximum plasma concentration (Cmax), Area under the plasma concentration curve (AUClast and AUC))', 'timeFrame': '56 days'}], 'secondaryOutcomes': [{'measure': 'Clinical safety evaluation (AE reporting, laboratory tests (hematology, biochemistry and urinalysis), vital signs and ECG parameters)', 'timeFrame': 'Up to 12 weeks (until the end of study visit)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n\\- To determine the effect of severe renal impairment on the pharmacokinetic profile of teriflunomide administered as a single 14 mg dose as compared to healthy subjects\n\nSecondary Objective:\n\n\\- To assess the tolerability of teriflunomide administered as a single 14 mg dose in subjects with severe renal impairment compared to subjects with normal renal function.', 'detailedDescription': 'The total study duration per subject is 11-15 weeks broken down as follows:\n\n* Screening: up to 3 weeks\n* Hospitalization: 3 days (admission 1 day prior to study drug intake)\n* Follow-up: 10 -12 weeks'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\nSubjects with renal impairment:\n\n* Male subject between 18 and 75 years of age inclusive and postmenopausal female between 45 and 75 years of age inclusive.\n* Chronic severe renal impairment as defined by Cockroft-Gault formula (creatinine clearance (CLcr) \\< 30mL/min, but not requiring hemodialysis).\n* Laboratory parameters within the acceptable range for subjects with renal impairment; in particular, hepatic enzymes (ALT, AST) and bilirubin should be \\< 2 x upper limit of normal range and neutrophils should be within normal ranges.\n\nMatched healthy subjects:\n\n* Male subject between 18 and 75 years of age inclusive and postmenopausal female between 45 and 75 years of age inclusive, matched by age.\n* Body weight within 15% of the body weight of the subjects with renal impairment to be matched and Body Mass Index between 18.0 and 30.0 mg/kg2 inclusive.\n* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Normal renal function as defined by Cockroft-Gault formula (creatinine clearance (CLcr) \\> 80mL/min)\n* Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects; however serum creatinine, alkaline phosphatase, hepatic enzymes (AST, ALT), bilirubin (unless the subject has documented Gilbert syndrome) should not exceed the upper limit of normal range.\n\nExclusion criteria:\n\nSubjects with renal impairment:\n\n* Uncontrolled clinically relevant cardiovascular, pulmonary, gastro-intestinal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female) or infectious disease, or signs of acute illness.\n* Active hepatitis, hepatic insufficiency.\n* Acute renal failure (de novo or superimposed to pre-existing chronic renal impairment), nephrotic syndrome.\n* Subject requiring dialysis during the study.\n* Any significant change in chronic treatment medication within 14-days before inclusion.\n* Any drug, which could impact by any mechanism of action, the pharmacokinetic of the investigational product.\n* Positive reaction to Human Immunodeficiency Virus (HIV) tests: anti-HIV1 antibodies, anti-HIV2 antibodies\n* Positive results on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates) unless this result is secondary to a documented medical prescription.\n* Positive alcohol test.\n* Man who disagrees to use a double barrier method of contraception with their partner during the study.\n\nMatched healthy subjects:\n\n* Any history or presence of clinically relevant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurological, psychiatric, systemic, ocular, gynecologic (if female), or infectious disease, or signs of acute illness.\n* For subjects 50 years old and below:\n\n * any medication (including St John's Wort) within 14 days before inclusion, or within 5 times the elimination half-life or pharmacodynamic halflife of that drug, whichever the longest, with the exception of menopausal hormone replacement therapy.\n * any significant change in chronic treatment medication within 14-days before inclusion.\n* Any drug, which could impact by any mechanism of action, the pharmacokinetic of the investigational product.\n* Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, antihepatitis C virus (anti-HCV) antibodies, HIV1 antibodies, anti-HIV2 antibodies.\n* Positive results on urine drug screen (amphetamines / methamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).\n* Positive alcohol test.\n* Man who disagrees to use a double barrier method of contraception with their partner during the study\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01239459', 'briefTitle': 'Pharmacokinetic and Tolerability Study of 14 mg Single Dose of Teriflunomide in Subjects With Severe Renal Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-label Pharmacokinetic and Tolerability Study of Teriflunomide Given as a Single 14 mg Dose in Subjects With Severe Renal Impairment, and in Matched Subjects With Normal Renal Function', 'orgStudyIdInfo': {'id': 'POP11432'}, 'secondaryIdInfos': [{'id': '2010-022354-16', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1117-6723', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Severe impaired renal function', 'description': 'Subjects with severe renal impairment as defined by Cockroft-Gault formula', 'interventionNames': ['Drug: Teriflunomide HMR1726', 'Drug: Cholestyramine']}, {'type': 'EXPERIMENTAL', 'label': 'Normal renal function', 'description': 'Subjects with normal renal function as defined by Cockroft-Gault formula', 'interventionNames': ['Drug: Teriflunomide HMR1726', 'Drug: Cholestyramine']}], 'interventions': [{'name': 'Teriflunomide HMR1726', 'type': 'DRUG', 'description': 'Pharmaceutical form:film coated tablet\n\nRoute of administration: oral administration on Day 1 under fasted condition', 'armGroupLabels': ['Normal renal function', 'Severe impaired renal function']}, {'name': 'Cholestyramine', 'type': 'DRUG', 'description': 'Pharmaceutical form:powder\n\nRoute of administration: oral administration 3 times per day on Day 54 and 55', 'armGroupLabels': ['Normal renal function', 'Severe impaired renal function']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}