Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2026-02-07 @ 6:51 PM
Study NCT ID:
NCT02307656
Status:
COMPLETED
Last Update Posted:
2022-01-05
First Post:
2014-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Taste Properties of Atazanavir and Cobicistat
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-15', 'studyFirstSubmitDate': '2014-10-29', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-09-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Incident of adverse events will be tabulated and reviewed for potential significance and clinical important', 'timeFrame': 'Approximately up to 2 years'}], 'primaryOutcomes': [{'measure': 'Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI Aromatic identity will be measured using the Flavor Profile of the Flavor Leadership Criteria', 'timeFrame': 'Every 6 weeks from the time of subject enrollment up to 2 years'}, {'measure': 'Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI amplitude will be measured using the Flavor Profile of the Flavor Leadership Criteria', 'timeFrame': 'Every 6 weeks from the time of subject enrollment up to 2 years'}, {'measure': 'Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI mouth-feel will be measured using the Flavor Profile of the Flavor Leadership Criteria', 'timeFrame': 'Every 6 weeks from the time of subject enrollment up to 2 years'}, {'measure': 'Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI off-notes will be measured using the Flavor Profile of the Flavor Leadership Criteria', 'timeFrame': 'Every 6 weeks from the time of subject enrollment up to 2 years'}, {'measure': 'Taste properties of ATV & COBI alone & in combination as well as oral test formulations containing both ATV & COBI aftertaste will be measured using the Flavor Profile of the Flavor Leadership Criteria', 'timeFrame': 'Every 6 weeks from the time of subject enrollment up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV in Adults']}, '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 primary objective is to assess the taste properties of atazanavir (ATV) and cobicistat (COBI) alone and in combination as well as oral test formulations containing both ATV and COBI.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com\n\nInclusion Criteria:\n\n* Men and women, ages ≥18 years\n* Subjects who are qualified professional sensory panelists\n* Healthy subjects as determined by no clinically significant deviation from normal in medical history and physical assessment\n\nExclusion Criteria:\n\n* Any acute or chronic condition that may alter taste or smell sensory perception\n* Any significant acute or chronic medical illness or any surgery within 4 weeks of the study drug administration\n* Positive HIV test using an oral swab kit (such as OraQuick®) to detect HIV-1 or -2 antibody'}, 'identificationModule': {'nctId': 'NCT02307656', 'briefTitle': 'Taste Properties of Atazanavir and Cobicistat', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Assessment of the Taste Properties of Atazanavir and Cobicistat and Pediatric Oral Test Formulations Containing Both Atazanavir and Cobicistat in Healthy Adults', 'orgStudyIdInfo': {'id': 'AI424-517'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Atazanavir and Cobicistat', 'description': 'Stage 1:Taste evaluation using Active Pharmaceutical Ingredient (API)\n\nStage 2:Taste Optimization using API (flavours and sweeteners)\n\nStage 3:Prototypes of the API - containing clinical trial materials', 'interventionNames': ['Drug: Atazanavir', 'Drug: Cobicistat', 'Drug: Active Pharmaceutical Ingredient']}], 'interventions': [{'name': 'Atazanavir', 'type': 'DRUG', 'armGroupLabels': ['Atazanavir and Cobicistat']}, {'name': 'Cobicistat', 'type': 'DRUG', 'armGroupLabels': ['Atazanavir and Cobicistat']}, {'name': 'Active Pharmaceutical Ingredient', 'type': 'DRUG', 'otherNames': ['(API)'], 'armGroupLabels': ['Atazanavir and Cobicistat']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01801', 'city': 'Woburn', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Senopsys Llc', 'geoPoint': {'lat': 42.47926, 'lon': -71.15228}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}