Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2026-02-22 @ 7:23 PM
Study NCT ID:
NCT02095860
Status:
COMPLETED
Last Update Posted:
2014-10-10
First Post:
2014-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-03-21', 'studyFirstSubmitQcDate': '2014-03-21', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of DCV, ASV and BMS-791325', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of DCV, ASV and BMS-791325', 'timeFrame': 'Day 1 to Day 13'}], 'secondaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] for DCV, ASV and BMS-791325', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Time of maximum observed plasma concentration (Tmax) for DCV, ASV and BMS-791325', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Terminal plasma half life (T-HALF) for DCV, ASV and BMS-791325', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'AUC(0-T) for BMS-794712', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'AUC(INF) for BMS-794712', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Cmax for BMS-794712', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Tmax for BMS-794712', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'T-HALF for BMS-794712', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety measured by incidence of adverse event (AEs), serious AEs (SAEs) and AEs leading to discontinuation', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety measured by abnormalities in vital sign measurements', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety measured by findings on electrocardiograms (ECG) measurements and physical examinations', 'timeFrame': 'Day 1 to Day 13'}, {'measure': 'Safety measured by marked abnormalities in clinical laboratory test results', 'timeFrame': 'Day 1 to Day 13'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/studyconnect/Pages/home.aspx', 'label': 'BMS clinical trial educational resource'}, {'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 effect of a high fat meal and light meal on the blood levels of Daclatasvir, Asunaprevir and BMS-791325 after administration of the 3 drugs as a fixed-dose combination in healthy subjects.', 'detailedDescription': 'IND Number: 100,932/79,599/101,943\n\nPrimary Purpose:\n\nOther: Phase 1 clinical pharmacology bioavailability study to assess food effect'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Healthy male and female subjects ages 18 to 49 years, inclusive.\n* Women of childbearing potential must be using an acceptable method of contraception for at least 4 weeks prior to study drug administration.\n\nExclusion Criteria:\n\n* Any significant acute or chronic medical illness\n* Current or recent (within 3 months of study drug administration) gastrointestinal disease\n* Any gastrointestinal surgery that could impact upon the absorption of study drug, including cholecystectomy\n* History of biliary disorders, including Gilbert's syndrome or Dubin-Johnson disease\n* Use of tobacco-containing or nicotine-containing products\n* Any of the following on 12-lead electrocardiogram (ECG) prior to study drug administration, confirmed by repeat:\n\n * PR ≥210 msec\n * QRS ≥120 msec\n * QT ≥500 msec\n * QTcF ≥450 msec\n* Any of the following laboratory results outside of the ranges specified below prior to study drug administration, confirmed by repeat:\n\n * Alanine aminotransferase (ALT) \\>Upper limit of normal (ULN)\n * Aspartate aminotransferase (AST) \\>ULN\n * Total bilirubin (TBILI) \\>ULN\n * Creatinine \\>ULN"}, 'identificationModule': {'nctId': 'NCT02095860', 'briefTitle': 'Food Effect of a Fixed Dose Combination of Daclatasvir, Asunaprevir and BMS-791325', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Randomized, Crossover Study to Assess the Effect of Food on the Pharmacokinetics of Daclatasvir, Asunaprevir, and BMS-791325 Following Administration of a Single Fixed Dose Combination of DCV 3DAA FDC in Healthy Subjects', 'orgStudyIdInfo': {'id': 'AI443-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A: DCV 3DAA FDC fasted state', 'description': 'DCV 3 Direct Acting Antiviral (DAA) Fixed Dose Combination (FDC) tablet by mouth once on specified days in fasted state', 'interventionNames': ['Drug: DCV 3DAA FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: DCV 3DAA FDC with high-fat meal', 'description': 'DCV 3DAA FDC tablet by mouth once on specified days with high-fat meal', 'interventionNames': ['Drug: DCV 3DAA FDC']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C: DCV 3DAA FDC with light meal', 'description': 'DCV 3DAA FDC tablet by mouth once on specified days with light meal', 'interventionNames': ['Drug: DCV 3DAA FDC']}], 'interventions': [{'name': 'DCV 3DAA FDC', 'type': 'DRUG', 'description': 'Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325', 'armGroupLabels': ['Treatment A: DCV 3DAA FDC fasted state', 'Treatment B: DCV 3DAA FDC with high-fat meal', 'Treatment C: DCV 3DAA FDC with light meal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78209', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Healthcare Discoveries, Llc D/B/A Icon Development Solutions', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}