Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-23 @ 11:35 AM
Study NCT ID:
NCT02805556
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2016-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}], 'ancestors': [{'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576364', 'term': 'fostemsavir'}, {'id': 'C584152', 'term': 'BMS-626529'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-18', 'studyFirstSubmitDate': '2016-05-31', 'studyFirstSubmitQcDate': '2016-06-15', 'lastUpdatePostDateStruct': {'date': '2017-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The absolute bioavailability of BMS-626529 after single oral (BMS-663068) and single intravenous dosing ([13C]-BMS-626529) by assessing the primary endpoints AUC(inf)', 'timeFrame': 'up to 11 days'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability of single oral dose of BMS-663068 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests', 'timeFrame': 'up to 31 days'}, {'measure': 'Safety and tolerability of single intravenous dose of [13C]-BMS-626529 as determined by medical review of adverse event reports, vital sign measurements, electrocardiograms (ECGs), and results of physical examination and laboratory tests', 'timeFrame': 'up to 31 days'}]}, 'conditionsModule': {'conditions': ['Infection, Human Immunodeficiency Virus']}, 'descriptionModule': {'briefSummary': 'A phase I absolute bioavailability study of BMS-626529 following oral and intravenous dosing'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* BMI 18.0-32.0 kg/m2\n* Men sexually active with women of childbearing potential must follow instructions for contraception for the duration of treatment plus 90 days\n* Men must refrain from sperm donation for the length of the study and for 90 days\n* Sign informed consent\n\nExclusion Criteria:\n\n* Significant medical illness\n* Tobacco use in the last 12 months\n* Major surgery within 4 weeks of study administration\n* Donation of blood within 4 weeks of study administration\n* Current or recent (within 3 months of study administration) of gastrointestinal disease'}, 'identificationModule': {'nctId': 'NCT02805556', 'briefTitle': 'Absolute Bioavailability of BMS-626529 After Oral and Intravenous Dosing', 'organization': {'class': 'INDUSTRY', 'fullName': 'ViiV Healthcare'}, 'officialTitle': 'Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529', 'orgStudyIdInfo': {'id': '206218'}, 'secondaryIdInfos': [{'id': 'AI438-075', 'type': 'OTHER', 'domain': 'Bristol-Myers Squibb'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529', 'description': 'Single oral dose of BMS-663068 followed by Single intravenous dose of \\[13C\\]BMS 626529', 'interventionNames': ['Drug: BMS-663068', 'Drug: BMS-626529']}], 'interventions': [{'name': 'BMS-663068', 'type': 'DRUG', 'description': 'Single oral dose of BMS-663068', 'armGroupLabels': ['Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529']}, {'name': 'BMS-626529', 'type': 'DRUG', 'description': 'Single intravenous dose of \\[13C\\]BMS 626529', 'armGroupLabels': ['Oral dose of BMS-663068 + intravenous dose of [13C]BMS 626529']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'BT 28 2 RF', 'city': 'Lisburn', 'country': 'United Kingdom', 'facility': 'GSK Investigational Site', 'geoPoint': {'lat': 54.52337, 'lon': -6.03527}}], 'overallOfficials': [{'name': 'GSK Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ViiV Healthcare'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ViiV Healthcare', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'GlaxoSmithKline', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}