Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2025-12-25 @ 2:55 PM
Study NCT ID:
NCT04263350
Status:
COMPLETED
Last Update Posted:
2021-11-23
First Post:
2020-02-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069446', 'term': 'Atazanavir Sulfate'}, {'id': 'D000069547', 'term': 'Cobicistat'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D002219', 'term': 'Carbamates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-18', 'studyFirstSubmitDate': '2020-02-07', 'studyFirstSubmitQcDate': '2020-02-07', 'lastUpdatePostDateStruct': {'date': '2021-11-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration (Cmax) of Atazanavir (ATV)', 'timeFrame': 'Up to Day 10'}, {'measure': 'Cmax of Cobicistat (COBI)', 'timeFrame': 'Up to Day 10'}, {'measure': 'Area under the plasma concentration- time Curve from time zero extrapolated to infinite time (AUC(INF)) of ATV', 'timeFrame': 'Up to Day 10'}, {'measure': 'AUC(INF) of COBI', 'timeFrame': 'Up to Day 10'}], 'secondaryOutcomes': [{'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 70 days'}, {'measure': 'Incidence of AEs leading to discontinuation', 'timeFrame': 'Up to 40 days'}, {'measure': 'Incidence of deaths', 'timeFrame': 'Up to 40 days'}, {'measure': 'Marked abnormalities in clinical laboratory test results', 'timeFrame': 'Up to 40 days'}, {'measure': 'Incidence of marked abnormalities in vital sign measurements: Blood Pressure', 'timeFrame': 'Up to 40 days'}, {'measure': 'Incidence of marked abnormalities in vital sign measurements: Heart Rate', 'timeFrame': 'Up to 40 days'}, {'measure': 'Incidence of marked abnormalities in Electrocardiogram (ECG) recording', 'timeFrame': 'Up to 40 days'}, {'measure': 'Incidence of Palatability questionnaire results', 'timeFrame': 'Up to 40 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Participants'], 'conditions': ['Healthy Participants']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.bmsstudyconnect.com/s/US/English/USenHome', 'label': 'BMS Clinical Trial Patient Recruiting'}, {'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the amount of Atazanavir (ATV) and Cobicistat (COBI) in the bodies of healthy adult participants when taken as a combination formulation, and when ATV is administered as an oral powder at the same time as COBI administered as an oral tablet. The ATV/COBI combination formulation and ATV powder will be taken with food.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '49 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.\n\nInclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 32.0 kg/m2, inclusive.\n* Women and men must agree to follow specific methods of contraception, if applicable.\n\nExclusion Criteria:\n\n* History of a clinically significant drug rash or Stevens-Johnson Syndrome\n* History of Gilbert's Syndrome\n* Current or recent (within 3 months of administration) gastrointestinal disease that could impact upon the absorption of study treatment\n* Any major surgery within 4 weeks of study treatment administration\n* Any gastrointestinal surgery that could impact upon the absorption of study treatment\n\nOther protocol-defined inclusion/exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04263350', 'briefTitle': 'A Study to Examine the Acceptable Taste and to Estimate the Amount of Atazanavir and Cobicistat in the Body When Taken as a Combination Product Versus When Taken as Separate Products at the Same Time', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Randomized Crossover Study to Obtain a Preliminary Estimate of the Bioavailability of Atazanavir and Cobicistat When Administered in an Age-appropriate Fixed-Dose Combination Formulation Compared With Coadministration of the Age-appropriate Atazanavir and Cobicistat Individual Formulations and to Assess Preliminary Palatability/Acceptability in Healthy Adults', 'orgStudyIdInfo': {'id': 'AI424-567'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A:Fixed- dose combination mini-tablet', 'interventionNames': ['Drug: Atazanavir/Cobicistat']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B: Separate products taken at the same time', 'interventionNames': ['Drug: Reyataz Atazanavir', 'Drug: Cobicistat']}], 'interventions': [{'name': 'Atazanavir/Cobicistat', 'type': 'DRUG', 'otherNames': ['ATV/COBI'], 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Treatment A:Fixed- dose combination mini-tablet']}, {'name': 'Reyataz Atazanavir', 'type': 'DRUG', 'otherNames': ['REYATAZ (ATV)'], 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Treatment B: Separate products taken at the same time']}, {'name': 'Cobicistat', 'type': 'DRUG', 'otherNames': ['COBI'], 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Treatment B: Separate products taken at the same time']}]}, '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': {'type': 'SPONSOR'}}}}