Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 8:17 PM
Study NCT ID:
NCT02089061
Status:
COMPLETED
Last Update Posted:
2014-08-15
First Post:
2014-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Statin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054058', 'term': 'Acute Coronary Syndrome'}], 'ancestors': [{'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-13', 'studyFirstSubmitDate': '2014-03-14', 'studyFirstSubmitQcDate': '2014-03-14', 'lastUpdatePostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of Rosuvastatin and Atorvastatin', 'timeFrame': '28 timepoints up to day 10'}, {'measure': 'Area under the plasma concentration-time curve from time zero to 72 hours (AUC(0-72)) of Rosuvastatin and Atorvastatin', 'timeFrame': '26 timepoints up to day 8'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Rosuvastatin and Atorvastatin', 'timeFrame': '28 timepoints up to day 10'}, {'measure': 'Area under the plasma concentration-time curve from time zero extrapolated to infinite time (AUC(INF)) of Rosuvastatin and Atorvastatin', 'timeFrame': '28 timepoints up to day 10'}], 'secondaryOutcomes': [{'measure': 'Time of maximum observed plasma concentration (Tmax) of Rosuvastatin and Atorvastatin', 'timeFrame': '28 timepoints up to day 10'}, {'measure': 'Terminal plasma half life (T-HALF) of Rosuvastatin and Atorvastatin', 'timeFrame': '28 timepoints up to day 10'}, {'measure': 'Apparent total body clearance (CLT/F) of Rosuvastatin and Atorvastatin', 'timeFrame': '28 timepoints up to day 10'}, {'measure': 'Safety based on results of physical examinations, vital sign measurements, ECGs, 24-hour telemetry, clinical laboratory tests, and physical measurements and will also include the incidence of AEs, SAEs and AEs leading to discontinuation', 'timeFrame': 'Up to day 10', 'description': 'Adverse Event (AE)\n\nSerious Adverse Event (SAE)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Acute Coronary Syndromes']}, 'descriptionModule': {'briefSummary': 'This purpose of this study is to assess the effects of BMS-919373 on the single dose Pharmacokinetics (PK) of Rosuvastatin and Atorvastatin in healthy subjects.', 'detailedDescription': 'Primary Purpose: Other - To assess the effects of BMS-919373 on the single dose PK of Rosuvastatin and Atorvastatin in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 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* Signed Written Informed Consent form\n* Healthy subjects as determined by no clinically significant deviation from normal in medical and surgical history, physical examination, physical measurements, vital signs, 12-lead ECG, 24-hour telemetry, and clinical laboratory tests\n* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive\n* Men and women, ages 18 to 55 yrs, inclusive\n\nExclusion Criteria:\n\n* Current or history of cardiovascular diseases, including arrhythmias, coronary heart disease, and congestive heart failure\n* Current or history of symptomatic hypotension\n* Current or history of liver diseases, including cirrhosis and liver failure\n* Current or history of kidney diseases, including nephrotic syndrome, renal failure, nephrolithiasis, and urolithiasis\n* Current or history of neurological diseases, including presyncope, syncope, convulsive disorders such as epilepsy, cerebral thrombosis and cerebral embolism, transient ischemic attack, and stroke; or mental disorders Exceptions for presyncope/syncope related to vasovagal responses are allowable at the discretion of the investigator\n* History of significant head injury in the last 2 years'}, 'identificationModule': {'nctId': 'NCT02089061', 'briefTitle': 'Drug Interaction Statin', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1 Open-label, Single-sequence Study to Evaluate the Effect of Coadministration of BMS-919373 on the Single-dose Pharmacokinetics of Rosuvastatin and Atorvastatin in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CV205-029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1: Rosuvastatin + BMS-919373', 'description': 'Rosuvastatin 10 mg tablet orally once for Day 1 and 5\n\nBMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension', 'interventionNames': ['Drug: BMS-919373', 'Drug: Rosuvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2: Atorvastatin + BMS-919373', 'description': 'Atorvastatin 40 mg tablet once for Days 1 and 5\n\nBMS-919373: 100 mg dose on Day 4 and 30 mg dose once daily on Days 5, 6 and 7 of Microcrystalline suspension', 'interventionNames': ['Drug: BMS-919373', 'Drug: Atorvastatin']}], 'interventions': [{'name': 'BMS-919373', 'type': 'DRUG', 'otherNames': ['IKur Inhibitor'], 'armGroupLabels': ['Cohort 1: Rosuvastatin + BMS-919373', 'Cohort 2: Atorvastatin + BMS-919373']}, {'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Crestor®'], 'armGroupLabels': ['Cohort 1: Rosuvastatin + BMS-919373']}, {'name': 'Atorvastatin', 'type': 'DRUG', 'otherNames': ['Lipitor®'], 'armGroupLabels': ['Cohort 2: Atorvastatin + BMS-919373']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}