Ignite Creation Date:
2025-12-24 @ 1:30 PM
Ignite Modification Date:
2025-12-27 @ 11:21 AM
Study NCT ID:
NCT04550195
Status:
COMPLETED
Last Update Posted:
2022-02-25
First Post:
2020-09-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015738', 'term': 'Famotidine'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-09', 'studyFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2022-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Adverse Events (AEs)', 'timeFrame': 'Up to 30 days'}, {'measure': 'Incidence of Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 81 days'}, {'measure': 'Incidence of AEs leading to discontinuation', 'timeFrame': 'Up to 30 days'}, {'measure': 'Number of clinically significant changes in clinical laboratory values: Hematology tests', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes in clinical laboratory values: Urinalysis tests', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes in clinical laboratory values: Clinical chemistry tests', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes from baseline in vital signs: Heart Rate', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes from baseline in vital signs: Body Temperature', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes from baseline in vital signs: Blood Pressure', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes from baseline in vital signs: Respiratory Rate', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes in electrocardiogram (ECG) parameters: Heart rate (HR)', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes from baseline in physical examinations', 'timeFrame': 'Up to 51 days'}, {'measure': 'Number of clinically significant changes in ECG parameters: PR interval', 'timeFrame': 'Up to 51 days', 'description': 'PR interval is the time from the onset of the P wave to the start of the QRS complex'}, {'measure': 'Number of clinically significant changes in ECG parameters: QRS duration', 'timeFrame': 'Up to 51 days', 'description': 'QRS can be defined as the electrical impulse as it spreads through the ventricles, indicating ventricular depolarization'}, {'measure': "Number of clinically significant changes in ECG parameters: QTc-interval (Fridericia's)", 'timeFrame': 'Up to 51 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.'}, {'measure': 'Number of clinically significant changes in ECG parameters: QT interval', 'timeFrame': 'Up to 51 days', 'description': 'The QT interval is the time from the start of the Q wave to the end of the T wave.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy volunteers'], 'conditions': ['Healthy Volunteers']}, '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-986337 in healthy participants and in healthy Japanese participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* No clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations\n* For Japanese cohorts in Part C, must be first-generation Japanese (born in Japan, not living outside of Japan for more than 10 years, and both parents are ethnically Japanese)\n* Body mass index (BMI) of 18.0 kg/m\\^2 to 30.0 kg/m\\^2, inclusive, at screening; BMI = weight (kg)/height (m)\\^2\n* Women and men must agree to follow specific methods of contraception, if applicable\n\nExclusion Criteria:\n\n* Women who are of childbearing potential\n* Women who are breastfeeding\n* Prior exposure to BMS-986278\n* Positive nasopharyngeal reverse transcriptase polymerase chain reaction (RT-PCR) test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on Day -2\n\nOther protocol-defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT04550195', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, and Drug Levels of BMS-986337 When Taken by Mouth by Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Double-Blind, Placebo-Controlled, Randomized, Single and Multiple Ascending Dose Study of the Safety and Tolerability, and Pharmacokinetics (Including Food Effect, pH Effect and Japanese Bridging Study) of BMS-986337 Following Oral Administration in Healthy Participants', 'orgStudyIdInfo': {'id': 'IM037-009'}, 'secondaryIdInfos': [{'id': '2019-004518-32', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part A Single Ascending Dose (SAD) Cohort A1', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD Cohort A2', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD Cohort A3', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD Cohort A4', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD Cohort A5', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part A SAD Cohort A6', 'interventionNames': ['Drug: BMS-986337', 'Biological: Famotidine']}, {'type': 'EXPERIMENTAL', 'label': 'Part B Multiple Ascending Dose (MAD) Cohort B1', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD Cohort B2', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD Cohort B3', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part B MAD Cohort B4', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C MAD in Japanese Healthy participants Cohort C1', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C MAD in Japanese Healthy participants Cohort C2', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part C MAD in Japanese Healthy participants Cohort C3', 'interventionNames': ['Drug: BMS-986337', 'Other: BMS-986337 Placebo']}], 'interventions': [{'name': 'BMS-986337', 'type': 'DRUG', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Part A SAD Cohort A2', 'Part A SAD Cohort A3', 'Part A SAD Cohort A4', 'Part A SAD Cohort A5', 'Part A SAD Cohort A6', 'Part A Single Ascending Dose (SAD) Cohort A1', 'Part B MAD Cohort B2', 'Part B MAD Cohort B3', 'Part B MAD Cohort B4', 'Part B Multiple Ascending Dose (MAD) Cohort B1', 'Part C MAD in Japanese Healthy participants Cohort C1', 'Part C MAD in Japanese Healthy participants Cohort C2', 'Part C MAD in Japanese Healthy participants Cohort C3']}, {'name': 'BMS-986337 Placebo', 'type': 'OTHER', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Part A SAD Cohort A2', 'Part A SAD Cohort A3', 'Part A SAD Cohort A4', 'Part A SAD Cohort A5', 'Part A Single Ascending Dose (SAD) Cohort A1', 'Part B MAD Cohort B2', 'Part B MAD Cohort B3', 'Part B MAD Cohort B4', 'Part B Multiple Ascending Dose (MAD) Cohort B1', 'Part C MAD in Japanese Healthy participants Cohort C1', 'Part C MAD in Japanese Healthy participants Cohort C2', 'Part C MAD in Japanese Healthy participants Cohort C3']}, {'name': 'Famotidine', 'type': 'BIOLOGICAL', 'description': 'Specified Dose on Specified Days', 'armGroupLabels': ['Part A SAD Cohort A6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9728 NZ', 'city': 'Groningen', 'country': 'Netherlands', 'facility': 'ICON Plc (PRA Health Sciences) - Netherlands', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}