Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-01-01 @ 4:34 PM
Study NCT ID:
NCT00909766
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2009-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese 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', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 113}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'dispFirstSubmitDate': '2015-09-23', 'completionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-12', 'studyFirstSubmitDate': '2009-05-22', 'dispFirstSubmitQcDate': '2015-10-12', 'studyFirstSubmitQcDate': '2009-05-27', 'dispFirstPostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety: safety assessments will be based on adverse event reports and the results of vital sign measurements, electrocardiograms, physical examinations and clinical laboratory tests', 'timeFrame': 'Within 2 weeks after study drug administration'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics: to assess the multiple-dose PK of BMS-830216', 'timeFrame': 'Within 2 weeks of study drug administration'}, {'measure': 'Pharmacodynamics: to assess the pharmacodynamic effect of BMS-830216 on body weight and BMI over 4 weeks of therapy', 'timeFrame': 'Within 2 weeks of 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, tolerability and effect on body weight and other obesity-related factors of different doses of BMS-830216, compared to placebo. The study will also determine the amount of BMS-830216 in the blood.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Obese subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations\n* Body Mass Index (BMI) of 30 to 40 kg/m², inclusive\n* Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men, ages 18 to 55, inclusive\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 beyond what is consistent with the target population\n* Female of childbearing potential\n* Sexually active fertile male not using effective birth control method (for example, condom) if your partners are females of childbearing potential\n* Abnormal blood work results (for example, triglyceride ≥ 400 mg/dL, glucose ≥126 mg/dL and total cholesterol ≥ 300 mg/dL)\n* High blood pressure (≥160/95 mm Hg)\n* Major surgical procedure within 4 weeks prior to randomization\n* Chronic infections (e.g., HIV \\[human immunodeficiency virus\\] or Hepatitis C)\n* Clinically significant history or presence of any of the following conditions: heart, liver, or kidney disease, neurologic or psychiatric disease, or a previous surgery for weight loss\n* History of gastrointestinal disease within the past 3 months\n* History of Type I or Type II diabetes in the past 12 months\n* A lifetime history of a suicide attempt or history of any suicidal behavior in the past month\n* Any clinically significant medical condition that could potentially affect your participation in the study and/or personal well-being, as judged by the investigator\n* Used grapefruit or grapefruit juice within 1 week prior to randomization\n* Donated blood or blood products to a blood bank, blood transfusion or participated in a clinical study (except a screening visit) requiring withdrawal of blood within 4 weeks prior to randomization\n* Unable to tolerate oral and/or intravenous (IV) medications\n* Unable to tolerate the puncturing of veins for drawing of blood\n* Prior exposure to BMS-830216\n* History of prior weight loss (for example, gastric bypass or gastric banding) or gastrointestinal surgery that could impact the absorption of study drug\n* History of a Major Depressive Disorder within the past 2 years\n* Known allergy or hypersensitivity to any component of the study medication\n* History of any significant drug allergies (such as anaphylaxis or hepatotoxicity)\n* Used any oral, injectable or implantable hormonal contraceptive agents (for example, birth control pills, Depo-Provera, or NuvaRing) within 3 months prior to randomization\n* Used any prescription drugs or over the counter products to control acid (for example, Prevacid, Mylanta or Rolaids) within 4 weeks prior to randomization\n* Used any prescription drugs, over the counter medications and herbal preparations within 1 week prior to randomization\n* Taken St. John's Wort within 1 week prior to randomization\n* Taken any investigational drug or placebo (inactive drug) within 4 weeks prior to randomization"}, 'identificationModule': {'nctId': 'NCT00909766', 'briefTitle': 'Safety, Pharmacokinetics and Pharmacodynamics Study to Evaluate BMS-830216 in Obese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose and Parallel Arm Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-830216 (Prodrug of BMS-819881) in Obese Subjects', 'orgStudyIdInfo': {'id': 'MB123-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Panel A', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panel B', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panel C', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panel D', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panel E', 'interventionNames': ['Drug: BMS-830216', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panel F', 'description': 'Low Dose', 'interventionNames': ['Drug: BMS-830216']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Panel G', 'description': 'High Dose', 'interventionNames': ['Drug: BMS-830216']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Panel H', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, Oral, 30 mg, once daily, 28 days', 'armGroupLabels': ['Panel A']}, {'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, Oral, 100 mg, once daily, 28 days', 'armGroupLabels': ['Panel B']}, {'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, oral, 300 mg, once daily, 28 days', 'armGroupLabels': ['Panel C']}, {'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, oral, 600 mg, once daily 28 days', 'armGroupLabels': ['Panel D']}, {'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, oral, 1200 mg, once daily, 28 days', 'armGroupLabels': ['Panel E']}, {'name': 'BMS-830216', 'type': 'DRUG', 'description': 'Capsules, Oral, to be determined, once daily, 28 days', 'armGroupLabels': ['Panel F', 'Panel G']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Capsules, Oral, 0 mg, once daily, 28 days', 'armGroupLabels': ['Panel A', 'Panel B', 'Panel C', 'Panel D', 'Panel E', 'Panel H']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Bristol-Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}