Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-21 @ 2:22 PM
Study NCT ID:
NCT01359605
Status:
COMPLETED
Last Update Posted:
2011-12-20
First Post:
2011-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C545088', 'term': 'varespladib methyl'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-16', 'studyFirstSubmitDate': '2011-05-19', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2011-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the varespladib blood levels and radioactivity in blood, urine and fecal samples', 'timeFrame': '1 hour prior to drug, and post dose: 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16, 24, 36, 48, 60, 72, 96, and 120 hours after drug'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ADME', 'Healthy volunteers'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to characterize the metabolism and excretion (ADME) of a single oral dose of \\[14C\\]varespladib methyl.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Provision of signed, written and dated informed consent prior to any study specific procedure\n* Healthy males, 19 to 55 years of age\n* Have a body mass index (BMI) between 18 and 35 kg/m2 inclusive\n\nExclusion Criteria:\n\n* History or presence of any clinically significant disease or disorder in the opinion of the investigator\n* Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, or vital signs at baseline in the opinion of the investigator'}, 'identificationModule': {'nctId': 'NCT01359605', 'briefTitle': 'Study to Assess the Metabolism and Elimination of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Anthera Pharmaceuticals'}, 'officialTitle': 'An Open-Label, Single-Dose, Study to Assess the Metabolism and Elimination of Varespladib After Oral Administration of [14C]-Labeled Varespladib Methyl in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'AN-CVD2215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'varespladib methyl', 'interventionNames': ['Drug: varespladib methyl']}], 'interventions': [{'name': 'varespladib methyl', 'type': 'DRUG', 'description': '500 mg oral suspension', 'armGroupLabels': ['varespladib methyl']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Anthera Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}