Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2026-03-15 @ 9:33 PM
Study NCT ID:
NCT02044627
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2014-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006949', 'term': 'Hyperlipidemias'}], 'ancestors': [{'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-13', 'studyFirstSubmitDate': '2014-01-21', 'studyFirstSubmitQcDate': '2014-01-22', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Level of [14C]-ETC-1002 in urine and feces after a single dose', 'timeFrame': '11 days', 'description': 'using mass balance recovery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hyperlipidemia']}, 'descriptionModule': {'briefSummary': 'This Phase 1 study will assess the mass balance recover of carbon-14 (14C) labelled ETC-1002 and the routes and rates of excretion of \\[14C\\]-ETC-1002'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Male Volunteers\n* BMI 10-35 kg/m2\n\nExclusion Criteria:\n\n* Hx of CV, renal, hepatic, chronic respiratory or GI disease\n* Hx of drug or alcohol abuse\n* smoking within 12 mos of screening'}, 'identificationModule': {'nctId': 'NCT02044627', 'briefTitle': 'Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002', 'organization': {'class': 'INDUSTRY', 'fullName': 'Esperion Therapeutics, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label,Single Radiolabeled Dose Study to Investigate the Absorption, Metabolism and Excretion of [14C]-ETC-1002 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': '1002-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1 dose of [14C-ETC-1002]', 'interventionNames': ['Drug: [14C-ETC-1002]']}], 'interventions': [{'name': '[14C-ETC-1002]', 'type': 'DRUG', 'armGroupLabels': ['1 dose of [14C-ETC-1002]']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6Js', 'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Stuart Mair, MBChB, DRCOG, DCPSA, MFPM', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Clinical, Mere Way, Ruddington Fields, Ruddington, Nottinham NG11 6JS, UK'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Esperion Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}