Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-01 @ 10:42 AM
Study NCT ID:
NCT04116632
Status:
COMPLETED
Last Update Posted:
2020-05-15
First Post:
2019-10-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-14', 'studyFirstSubmitDate': '2019-10-03', 'studyFirstSubmitQcDate': '2019-10-03', 'lastUpdatePostDateStruct': {'date': '2020-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed plasma concentration of BMS-963272 (Cmax)', 'timeFrame': 'Day 1, Day 14'}, {'measure': 'Time of maximum observed concentration of BMS-963272 (Tmax)', 'timeFrame': 'Day 1, Day 14'}, {'measure': 'Area under the concentration-time curve in one dosing interval (AUC(TAU))', 'timeFrame': 'Day 1, Day 14'}, {'measure': 'Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC(0-T))', 'timeFrame': 'Day 14'}, {'measure': 'Apparent total clearance of the drug from plasma after oral administration (CLss/F)', 'timeFrame': 'Day 14'}, {'measure': 'Apparent volume of distribution at steady state (Vss/F)', 'timeFrame': 'Day 14'}, {'measure': 'Average concentration at steady state (Cavg,ss)', 'timeFrame': 'Day 14'}, {'measure': 'Half-life (T-HALF)', 'timeFrame': 'Day 14'}, {'measure': 'Accumulation index (AI)', 'timeFrame': 'Day 14'}, {'measure': 'Rate elimination constant (kel) of BMS-963272', 'timeFrame': 'Day 14'}, {'measure': 'Area under the concentration-time curve (AUC) of triglycerides (TG) and fatty acids in response to the oral lipid tolerance test (oLTT)', 'timeFrame': 'Day 7, Day 15'}, {'measure': 'Incremental AUC (iAUC) of TG and fatty acids in response to the oLTT', 'timeFrame': 'Day 7, Day 15'}], 'secondaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 55 days'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 55 days'}, {'measure': 'Number of clinically significant changes in vital signs, electrocardiograms (ECGs), physical examinations and clinical laboratory tests', 'timeFrame': 'Up to 55 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obese But Otherwise 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/investigator-inquiry-form.html', 'label': 'Investigator Inquiry Form'}, {'url': 'https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and tolerability of multiple doses of BMS-963272 in obese but otherwise healthy participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 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* Participants must be in good general health, in the opinion of the investigator, with no clinically significant deviation from normal in medical history, physical examination findings, ECGs, or laboratory results.\n* Participants must have a BMI of 30 kg/m2 to 40 kg/m2 inclusive\n* Women (not of childbearing potential) and men aged 18 to 60 years, inclusive\n\nExclusion Criteria:\n\n* Previous participation in the current study\n* Inability or unwillingness to comply with protocol-defined restrictions or requirements regarding lifestyle, diet, concomitant medications, or other aspects of the study\n* Inability to tolerate the oLTT meal or to comply with oLTT testing conditions\n* Inability to tolerate oral medication\n* Inability to tolerate venipuncture and/or inadequate venous access\n* Women who are breastfeeding\n* Medical Conditions\n* History of lactose intolerance\n* Any significant (in the opinion of the investigator) acute or chronic illness\n* Type 1 or 2 diabetes\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population\n* Previous/Concomitant Therapy\n* Previous exposure to BMS-963272\n\nOther protocol-defined inclusion/exclusion criteria could apply'}, 'identificationModule': {'nctId': 'NCT04116632', 'briefTitle': 'A Multiple Dose Study to Assess the Safety and Tolerability of BMS-963272 in Obese But Otherwise Healthy Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Multiple Dose Pharmacokinetic/Pharmacodynamic and Safety and Tolerability Study of BMS-963272 in Obese But Otherwise Healthy Adults', 'orgStudyIdInfo': {'id': 'MB006-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-963272 or Placebo once daily (QD)', 'interventionNames': ['Drug: BMS-963272', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-963272 or Placebo every 12 hours (Q12H)', 'interventionNames': ['Drug: BMS-963272', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-963272 or Placebo every 8 hours (Q8H)', 'interventionNames': ['Drug: BMS-963272', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-963272', 'type': 'DRUG', 'description': 'Single dose with varying frequency among groups', 'armGroupLabels': ['BMS-963272 or Placebo every 12 hours (Q12H)', 'BMS-963272 or Placebo every 8 hours (Q8H)', 'BMS-963272 or Placebo once daily (QD)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['BMS-963272 or Placebo every 12 hours (Q12H)', 'BMS-963272 or Placebo every 8 hours (Q8H)', 'BMS-963272 or Placebo once daily (QD)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRA Health Sciences - Lenexa', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}