Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2025-12-25 @ 9:35 PM
Study NCT ID:
NCT04926051
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2021-06-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2021-06-11', 'studyFirstSubmitQcDate': '2021-06-11', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of non-serious Adverse Events (AEs)', 'timeFrame': 'Up to 35 days'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 35 days'}, {'measure': 'Incidence of AEs leading to discontinuation of study treatment', 'timeFrame': 'Up to 35 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in physical examination', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Hematology tests', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Chemistry tests', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Urinalysis tests', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory values: Serology tests', 'timeFrame': 'Up to 28 days'}, {'measure': 'Incidence of clinically significant changes in ECG parameters: QTcF', 'timeFrame': 'Up to 28 days', 'description': 'QTcF = Corrected QT interval using the Fridericia formula. QT interval is the time from the start of the Q wave to the end of the T wave'}], 'secondaryOutcomes': [{'measure': 'Plasma concentrations of BMS-986172', 'timeFrame': 'Up to 28 days'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'Up to 28 days'}, {'measure': 'Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration (AUC(0-T))', 'timeFrame': 'Up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Participants', 'BMS-986172'], '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 evaluate the safety, tolerability and drug levels of BMS-986172 and evaluate the effects of food on BMS-986172 absorption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy participants as determined by no clinically significant deviation from normal in medical history, physical examination, vital signs, ECG, and clinical laboratory results as determined by the investigator or designee.\n* Participants in Part C must be first-generation Japanese participants. For the purpose of this study, first-generation Japanese is defined as native Japanese or first-generation Japanese living outside of Japan for \\<10 years.\n* BMI of ≥ 18 kg/m2 to ≤ 40.0 kg/m2, inclusive, at screening, except for high BMI cohort participants (Part B) which will be restricted to a BMI range of ≥ 30 kg/m2 to ≤ 40.0 kg/m2.\n\nExclusion Criteria:\n\n* Inability to tolerate the oral lipid meal or the testing conditions on Day -1, including but not limited to: bloating, nausea, vomiting, diarrhea, pain, or any discomfort due to oral lipid meal.\n* Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, liver disease, or intestinal disorder including irritable bowel syndrome.\n* History or presence of malignancy including hematological malignancies; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion, as judged by the investigator or designee.\n* Any significant acute or chronic medical illness.\n* History of SARS-CoV-2 infection (either suspected or confirmed) within 3 months prior to signing consent\n* Participants who have received a SARS-CoV-2 vaccine approved for Emergency Use Authorization by the US FDA that is not live attenuated may be considered for enrollment\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04926051', 'briefTitle': 'A Study to Assess the Safety, Tolerability and Drug Levels of BMS-986172 in Healthy and Obese Participants, Including an Assessment of the Effects of Food on BMS-986172 Absorption', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Phase 1, Double-blind, Placebo-controlled, Randomized, Single and Multiple Ascending Dose, and a Japanese Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of BMS-986172, Including an Open-Label Assessment of Relative Bioavailability and Food Effect on the Single-Dose Pharmacokinetics of BMS-986172 in Healthy and Obese Otherwise Healthy Participants', 'orgStudyIdInfo': {'id': 'MB008-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: SAD', 'description': 'SAD = Single Ascending Dose', 'interventionNames': ['Drug: BMS-986172', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: MAD', 'description': 'MAD = Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986172', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C: JMAD', 'description': 'JMAD= Japanese Multiple Ascending Dose', 'interventionNames': ['Drug: BMS-986172', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part D: FE/BA', 'description': 'FE/BA = Food Effect/Relative Bioavailability', 'interventionNames': ['Drug: BMS-986172']}], 'interventions': [{'name': 'BMS-986172', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: SAD', 'Part B: MAD', 'Part C: JMAD', 'Part D: FE/BA']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: SAD', 'Part B: MAD', 'Part C: JMAD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66215', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON Plc (Legacy PRA)', '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'}}}}