Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT04493567
Status:
COMPLETED
Last Update Posted:
2022-03-18
First Post:
2020-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000630067', 'term': 'Pegbelfermin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 102}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-07', 'studyFirstSubmitDate': '2020-07-28', 'studyFirstSubmitQcDate': '2020-07-28', 'lastUpdatePostDateStruct': {'date': '2022-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum observed serum concentration (Cmax)', 'timeFrame': 'Up to 29 days'}, {'measure': 'Area under the serum concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)]', 'timeFrame': 'Up to 29 days'}, {'measure': 'Area under the serum concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of C-terminal intact BMS-986036', 'timeFrame': 'Up to 29 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs)', 'timeFrame': 'Up to 115 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Hematology tests', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Clinical Chemistry tests', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in clinical laboratory results: Urinalysis tests', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Body temperature', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Respiratory rate', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Blood pressure', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in vital signs: Heart rate', 'timeFrame': 'Up to 85 days'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: PR interval', 'timeFrame': 'Up to 85 days', 'description': 'The PR interval is the time from the onset of the P wave to the start of the QRS complex.'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QRS interval', 'timeFrame': 'Up to 85 days', 'description': 'QRS interval: A combination of the Q wave, R wave and S wave, the "QRS complex" represents ventricular depolarization'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QT interval', 'timeFrame': 'Up to 85 days', 'description': 'The QT interval on the ECG is measured from the beginning of the QRS complex to the end of the T wave'}, {'measure': 'Incidence of clinically significant changes in electrocardiogram (ECG) parameters: QTcF interval', 'timeFrame': 'Up to 85 days', 'description': "Corrected QT interval using Fridericia's formula (QTcF)"}, {'measure': 'Incidence of clinically significant changes in physical examination findings', 'timeFrame': 'Up to 85 days'}, {'measure': 'Number of participants with local injection site reactions', 'timeFrame': 'Up to 57 days'}, {'measure': 'Number of participants with Antibodies to fibroblast growth factor 21 (FGF21)', 'timeFrame': 'Up to 57 days'}, {'measure': 'Number of participants with Antibodies to BMS-986036', 'timeFrame': 'Up to 57 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'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 develop an auto-injector (AI) device for the BMS-986036 subcutaneous formulation that can be self-administered conveniently by participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 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* Healthy, overweight, obese, male and female participants, as determined by normal in medical history, physical examination (PE), electrocardiograms (ECGs), and clinical laboratory determinations\n* Body mass index (BMI) of 25.0 kg/m2 to 40.0 kg/m2, inclusive i) Approximately 25% of participants will be overweight and have a BMI between 25 kg/m2 and 30 kg/m2, inclusive ii) Approximately 75% of participants will be obese and have a BMI \\> 30 kg/m2 to ≤ 40 kg/m2\n* Women and men must agree to follow specific methods of contraception, if applicable, while participating in the trial\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding\n* Inability to tolerate subcutaneous (SC) injections\n* Inability to be venipunctured and/or tolerate venous access\n* Any sound medical, psychiatric, and/or social reason as determined by the investigator\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04493567', 'briefTitle': 'Relative Levels of BMS-986036 in Blood Plasma in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'An Open-label, Randomized, Two-period Cross-over Study to Investigate the Relative Bioavailability of BMS-986036 in Healthy, Overweight, and Obese Participants Following Subcutaneous Administration Via Auto-injector Versus Pre-filled Syringe', 'orgStudyIdInfo': {'id': 'MB130-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe', 'interventionNames': ['Drug: BMS-986036']}, {'type': 'EXPERIMENTAL', 'label': 'Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe', 'interventionNames': ['Drug: BMS-986036']}], 'interventions': [{'name': 'BMS-986036', 'type': 'DRUG', 'description': 'Specified dose on specified days', 'armGroupLabels': ['Part A: 1 x BMS-986036 via auto-injector or pre-filled syringe', 'Part B: 2 x BMS-986036 via auto-injector or pre-filled syringe']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'ICON (LPRA) - Salt Lake', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}