Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-29 @ 7:06 PM
Study NCT ID:
NCT01448304
Status:
COMPLETED
Last Update Posted:
2013-06-28
First Post:
2011-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-27', 'studyFirstSubmitDate': '2011-10-05', 'studyFirstSubmitQcDate': '2011-10-05', 'lastUpdatePostDateStruct': {'date': '2013-06-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain using present pain intensity (PPI) verbal questionnaire', 'timeFrame': '6 weeks'}, {'measure': 'Erythema at injection site by measuring diameter and qualitative assessment', 'timeFrame': '6 weeks'}, {'measure': 'Edema at injection site by measuring diameter and qualitative assessment', 'timeFrame': '6 weeks'}], 'secondaryOutcomes': [{'measure': 'Assessment of PK parameter - time to maximum concentration (tmax)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - maximum concentration (Cmax)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - area under curve (AUC)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - cluster of differentiation (CD) biomarker (CD29)', 'timeFrame': 'Up to 12 weeks'}, {'measure': 'Assessment of PK parameter - terminal elimination half-life (t1/2z)', '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\nInjection Site Tolerability\n\nSecondary Objective:\n\n* To assess the safety profile of alirocumab SAR236553 (REGN727)\n* To assess the pharmacokinetic-pharmacodynamic relationship of alirocumab SAR236553 (REGN727)', 'detailedDescription': 'The total duration of study for each subject is up to 15 weeks including a screening period up to 3 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Serum LDL-C levels\\>100 mg/dL at screening visit.\n* Male or female subject, between 18 and 65 years inclusive.\n* Body weight between 50.0 and 95.0 kg inclusive if male, between 40.0 kg and 85.0 kg inclusive if female, body mass index (BMI) between 18.0 and 30.0 kg/m² inclusive.\n* Certified as healthy by a comprehensive clinical assessment (detailed medical history and complete physical examination).\n* Normal vital signs after 10 minutes resting in supine position.\n* Normal standard 12-lead ECG after 10 minutes resting in supine position.\n* Laboratory parameters within the normal range, unless the Investigator considers an abnormality to be clinically irrelevant for healthy subjects.\n* If female, subject must use a double contraception method, except if she is sterilized for more than 3 months or postmenopausal.\n\nExclusion Criteria:\n\n* Subjects indicated for the use of statins according to criteria in National Cholesterol Education Program adult treatment panel III Guidelines, as updated in 2004 (see Appendix C).\n* Initiation of a new diet or major change to a previous diet within 4 weeks prior to Screening (Day -21 to -2). Subjects must be willing to maintain a consistent diet for the duration of the study.\n* Use of a medication or nutraceutical in order to alter serum lipids within 4 weeks prior to screening (Day -21 to -2), including but not limited to statins, ezetimibe, fibrates, niacin, or omega-3 fatty acids, bile acid resins.\n* Fasting serum triglycerides \\>200 mg/dL measured after an 8 to 12 hour fast.\n* History of a hypersensitivity reaction to doxycycline or similar compound.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01448304', 'briefTitle': 'Study of the Tolerability, Safety, Pharmacokinetics and Pharmacodynamics of Alirocumab SAR236553 (REGN727)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'orgStudyIdInfo': {'id': 'PKD12011'}, 'secondaryIdInfos': [{'id': 'U1111-1119-3056', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) - Dose A', 'description': 'A single subcutaneous injection of Dose A', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}, {'type': 'EXPERIMENTAL', 'label': 'alirocumab SAR236553 (REGN727) - Dose B', 'description': 'A single subcutaneous injection of Dose B', 'interventionNames': ['Drug: alirocumab SAR236553 (REGN727)']}], 'interventions': [{'name': 'alirocumab SAR236553 (REGN727)', 'type': 'DRUG', 'description': 'Pharmaceutical form:Solution Route of administration: Subcutaneous', 'armGroupLabels': ['alirocumab SAR236553 (REGN727) - Dose A', 'alirocumab SAR236553 (REGN727) - Dose B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}], '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'}}}}