Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-04-16 @ 9:38 AM
Study NCT ID:
NCT01670734
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2012-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006937', 'term': 'Hypercholesterolemia'}], 'ancestors': [{'id': 'D006949', 'term': 'Hyperlipidemias'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571059', 'term': 'alirocumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2012-08-16', 'studyFirstSubmitQcDate': '2012-08-20', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics: Assessment of serum concentrations of alirocumab SAR236553 (REGN727)', 'timeFrame': 'Up to 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK parameter - terminal elimination half-life (t1/2z) [', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - apparent total body clearance (CL/F)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - Distribution volume at the steady-state (Vss/F)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - time to maximum concentration (tmax)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - Mean Residence Time (MRT [area])', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Pharmacodynamics: Change in LDL-C from baseline', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Number of participants with Adverse Events', 'timeFrame': 'Up to 12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hypercholesterolemia']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\nStudy the effect of mild or moderate hepatic impairment on the pharmacokinetics of alirocumab SAR236553 (REGN727).\n\nSecondary Objectives:\n\n* Assess the safety and tolerability of alirocumab SAR236553 (REGN727) in patients with mild and moderate hepatic impairment and in matched subjects with normal hepatic function.\n* Assess the pharmacodynamic profile of alirocumab SAR236553 (REGN727) in patients with hepatic impairment and in matched subjects with normal hepatic function.', 'detailedDescription': 'Total duration of the study per subject (excluding screening) is about 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria :\n\n* Male or female, between 18 to 75 years of age, inclusive.\n* Patients with mild and moderate hepatic impairment based on Child-Pugh score and stable chronic liver disease.\n* Healthy subjects with normal hepatic function.\n\nExclusion criteria:\n\n* Patients with acute hepatitis, hepatic encephalopathy grade 2, 3, and 4.\n* Patients with history or presence of uncontrolled clinically relevant illness.\n* Healthy subjects with history or presence of clinically relevant illness.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01670734', 'briefTitle': 'Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'An Open-Label, Pharmacokinetic and Tolerability Study of SAR236553/REGN727 Given as a Single SC Dose in Subjects With Mild and Moderate Hepatic Impairment, and in Matched Subjects With Normal Hepatic Function', 'orgStudyIdInfo': {'id': 'POP12671'}, 'secondaryIdInfos': [{'id': '2012-002292-33'}, {'id': 'U1111-1129-0248', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) - mild hepatic function', 'description': 'Injection through subcutaneous (SC) administration in patients with mild hepatic function', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}, {'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) - moderate hepatic function', 'description': 'Injection through subcutaneous (SC) administration in patients with moderate hepatic function', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}, {'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) - normal hepatic function', 'description': 'Injection through subcutaneous (SC) administration in patients with normal hepatic function', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}], 'interventions': [{'name': 'alirocumab SAR236553 (REGN727)', 'type': 'DRUG', 'description': 'alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)\n\nPharmaceutical form:Solution for injection Route of administration: subcutaneous', 'armGroupLabels': ['alirocumab SAR236553 (REGN727) - mild hepatic function', 'alirocumab SAR236553 (REGN727) - moderate hepatic function', 'alirocumab SAR236553 (REGN727) - normal hepatic function']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35000', 'city': 'Rennes', 'country': 'France', 'facility': 'Investigational Site Number 250001', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '2025', 'city': 'Chisinau', 'country': 'Moldova', 'facility': 'Investigational Site Number 498001', 'geoPoint': {'lat': 47.00902, 'lon': 28.85938}}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}