Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2026-02-20 @ 6:23 PM
Study NCT ID:
NCT00878020
Status:
COMPLETED
Last Update Posted:
2011-02-23
First Post:
2009-04-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety Study to Evaluate BMS-830216 in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-22', 'studyFirstSubmitDate': '2009-04-02', 'studyFirstSubmitQcDate': '2009-04-07', 'lastUpdatePostDateStruct': {'date': '2011-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events (AEs), vital signs, electrocardiogram (ECG) and clinical laboratory test results', 'timeFrame': 'Within the 10 days after study drug administration'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic profile (drug absorption, distribution, metabolism and excretion process) determined by plasma concentration vs. time profile from a series of plasma samples up to 10 days post dose', 'timeFrame': 'Within the 10 days after study drug administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Obesity']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety profile, tolerability, and pharmacokinetics of single oral doses from 10 mg up to 1200 mg of BMS-830216 (pro-drug of BMS-819881) in healthy subjects'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ECG), and clinical laboratory evaluations will be eligible to participate in the study\n* Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) and men between ages of 18 to 45\n\nExclusion Criteria:\n\n* Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations'}, 'identificationModule': {'nctId': 'NCT00878020', 'briefTitle': 'Safety Study to Evaluate BMS-830216 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of BMS-830216 (Pro-Drug of BMS-819881) in Healthy Subjects', 'orgStudyIdInfo': {'id': 'MB123-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 1', 'description': 'BMS-830216 (10 mg)', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 2', 'description': 'BMS-830216 (30 mg)', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 3', 'description': 'BMS-830216 (100 mg)', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 4', 'description': 'BMS-830216 (300 mg)', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 5', 'description': 'BMS-830216 (600 mg)', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm 6', 'description': 'BMS-830216 (1200 mg)', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, Oral, Single Dose, 1 day', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 5', 'Arm 6']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules, Oral, 0mg, Single Dose, 1 day', 'armGroupLabels': ['Arm 1', 'Arm 2', 'Arm 3', 'Arm 5', 'Arm 6']}, {'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, Oral, Single Dose on Day 1, Period 1 and Day 1, Period 2, 2 days', 'armGroupLabels': ['Arm 4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules, Oral, 0mg, Single Dose, on Day 1, Period 1 and Day 1, Period 2, 2 days', 'armGroupLabels': ['Arm 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Ppd Development, Lp', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}