Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-02-06 @ 6:10 PM
Study NCT ID:
NCT00904059
Status:
COMPLETED
Last Update Posted:
2011-01-07
First Post:
2009-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction Study in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C571889', 'term': 'asunaprevir'}, {'id': 'C549273', 'term': 'daclatasvir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-06', 'studyFirstSubmitDate': '2009-04-21', 'studyFirstSubmitQcDate': '2009-05-18', 'lastUpdatePostDateStruct': {'date': '2011-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic parameters including AUC (TAU) Cmax and Cmin', 'timeFrame': 'Day 21 pharmacokinetic assessment'}], 'secondaryOutcomes': [{'measure': 'To assess the safety, tolerability, and fractional excretion of sodium when BMS-709952 and BMS-650032 are co-administered', 'timeFrame': 'Within 24 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and BMS-650032 when co-administered and when administered alone', 'detailedDescription': 'Pharmacokinetics and Safety in Healthy Subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects aged 18 to 49 years\n* Females who are not of childbearing potential, pregnant or breastfeeding\n* Subject Body Mass Index (BMI) of 18 to 32 kg/m²\n\nExclusion Criteria:\n\n* Women of child bearing potential\n* Male subjects who have sex with women who are unwilling to agree to practice male barrier contraception during study participation and for a least 12 weeks following dosing\n* Any significant acute or chronic medical illness\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations\n* Prior exposure to BMS-650032 or BMS-790052\n* Positive for HIV or HCV'}, 'identificationModule': {'nctId': 'NCT00904059', 'briefTitle': 'Drug-Drug Interaction Study in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Open-Label, Randomized, Multiple-Dose, Drug-Drug Interaction Study to Assess the Pharmacokinetics and Safety of BMS-790052 and BMS-650032 Co-administered in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AI447-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Group A', 'interventionNames': ['Drug: BMS-650032']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group B', 'interventionNames': ['Drug: BMS-790052']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Group C', 'description': 'Treatment Groups A and B are followed by Treatment Group C: A combination of BMS-650032 (200 mg) and BMS-790052 (30 mg)', 'interventionNames': ['Drug: BMS-650032', 'Drug: BMS-790052']}], 'interventions': [{'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Capsules, Oral, 600 mg, Q12h, Days 1-7', 'armGroupLabels': ['Treatment Group A']}, {'name': 'BMS-790052', 'type': 'DRUG', 'description': 'Capsules, Oral, 60 mg, Q24h, Days 1-7', 'armGroupLabels': ['Treatment Group B']}, {'name': 'BMS-650032', 'type': 'DRUG', 'description': 'Capsules, Oral, 200 mg, Q12h, Days 8-21', 'armGroupLabels': ['Treatment Group C']}, {'name': 'BMS-790052', 'type': 'DRUG', 'description': 'Capsules, Oral, 30 mg, Q24h, Days 8-21', 'armGroupLabels': ['Treatment Group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ppd Development, Lp', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}