Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
Study NCT ID:
NCT00964912
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2009-08-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Single Dose Study of BMS-820836
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000594001', 'term': '6-(2-methyl-4-(2-naphthyl)-1,2,3,4-tetrahydroisoquinolin-7-yl)pyridazin-3-amine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-01', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2009-08-24', 'studyFirstSubmitQcDate': '2009-08-24', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the safety and tolerability of BMS-820836 following single-dose administration', 'timeFrame': 'Within 14 days of first dose'}], 'secondaryOutcomes': [{'measure': 'To assess the single-dose pharmacokinetics of BMS-820836 and its N-demethylated metabolite BMS-821007', 'timeFrame': 'Within 7 days of dosing'}, {'measure': 'To assess the pharmacodynamics of BMS-820836', 'timeFrame': 'Within 48 hours of dosing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression']}, '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 determine the safety and tolerability of BMS-820836 after single doses'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) of 18 to 30 kg/m2, inclusive and weight ≥ 50 kg\n* Right-handed, non-ambidextrous subjects for Part 2\n* Men and women, ages 18 to 55 years, inclusive\n\nExclusion Criteria:\n\n* Women of child bearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of investigational product\n* WOCBP using a prohibited contraceptive method\n* Women who are pregnant or breastfeeding\n* Sexually active fertile men not using effective birth control if their partners are WOCBP\n* Any significant acute or chronic medical illness\n* Current or recent (within 3 months) gastrointestinal disease\n* History of cholecystectomy\n* Any major surgery within 4 weeks of study drug administration\n* Any gastrointestinal surgery that could impact the absorption of study drug\n* Donation of blood or plasma to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration\n* Blood transfusion within 4 weeks of study drug administration\n* Inability to tolerate/swallow oral medication\n* Difficulty with venipuncture and/or poor venous access\n* Self-reported smokers\n* Recent (within 1 year) of psychostimulant use (cocaine, methylphenidate, amphetamines, ecstasy)\n* Confirmed resting supine systolic blood pressure \\> 130 mmHg\n* Confirmed resting supine diastolic blood pressure \\> 80 mmHg\n* Confirmed QT value ≥ 500 msec\n* Confirmed QTc (Bazett) value ≥ 450 msec\n* History of any significant drug allergy (such as anaphylaxis or hepatotoxicity)\n* History of peppermint allergies\n* History of brain conditions (e.g. history of stroke, head trauma, etc.)\n* History of or current psychiatric conditions\n* History of claustrophobia'}, 'identificationModule': {'nctId': 'NCT00964912', 'briefTitle': 'Single Dose Study of BMS-820836', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-820836 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CN162-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 1)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 2)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 3)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 4)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 5)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 6)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 7)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 8)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 1, Panel 9)', 'interventionNames': ['Drug: BMS-820836', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 2, Panel A)', 'interventionNames': ['Drug: BMS-820836']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-820836 (Part 2, Panel B)', 'interventionNames': ['Drug: BMS-820836']}], 'interventions': [{'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 0.025 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 1)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 0.1 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 2)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 0.25 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 3)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 0.5 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 4)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 1 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 5)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 2 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 6)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 3 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 7)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 5 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 8)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 8 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 9)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 0 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 1, Panel 1)', 'BMS-820836 (Part 1, Panel 2)', 'BMS-820836 (Part 1, Panel 3)', 'BMS-820836 (Part 1, Panel 4)', 'BMS-820836 (Part 1, Panel 5)', 'BMS-820836 (Part 1, Panel 6)', 'BMS-820836 (Part 1, Panel 7)', 'BMS-820836 (Part 1, Panel 8)', 'BMS-820836 (Part 1, Panel 9)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 3 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 2, Panel A)']}, {'name': 'BMS-820836', 'type': 'DRUG', 'description': 'Oral Solution, Oral, 0.5 mg, single dose, one dose', 'armGroupLabels': ['BMS-820836 (Part 2, Panel B)']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5V 2T3', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Local Institution', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], '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'}}}}