Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:56 PM
Study NCT ID:
NCT00949767
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2009-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-03', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-29', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary endpoint is safety and tolerability evaluated by VS, ECG, clinical lab assessments and AEs', 'timeFrame': 'up to Day 14 +/- 2 days post-dose'}], 'secondaryOutcomes': [{'measure': 'Single dose pharmacokinetics parameters of BMS-866949 [Cmax, Tmax, T-HALF, AUC (0-T), AUC (INF)] will be analyzed using blood samples', 'timeFrame': 'Blood samples will be taken up to 144 hour post-dose'}]}, '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 evaluate the safety profile, tolerability, pharmacokinetics and pharmacodynamics of ascending single doses of BMS-866949 in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male 18-55\n* Women not of child bearing potential, 18-55\n\nExclusion Criteria:\n\n* History of or current treatment for psychiatric illnesses, substance abuse or dependence\n* History of a clinically significant neurological disorder (e.g., history of stroke, head trauma, etc.)'}, 'identificationModule': {'nctId': 'NCT00949767', 'briefTitle': 'Safety, Pharmacokinetics and Pharmacodynamics Study of BMS-866949 in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Placebo-Controlled, Ascending Single-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of BMS-866949 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CN166-001'}, 'secondaryIdInfos': [{'id': 'EUDRACT # is 2009-010220-26'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 1)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 2)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 3)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 4)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 5)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 6)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'BMS-866949 (Panel 7)', 'interventionNames': ['Drug: BMS-866949', 'Drug: Placebo']}], 'interventions': [{'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 1 - 0.5 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 1)']}, {'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 2 - 2.5 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 2)']}, {'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 3 - 10 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 3)']}, {'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 4 - 25 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 4)']}, {'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 5 - 50 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 5)']}, {'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 6 - 100 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 6)']}, {'name': 'BMS-866949', 'type': 'DRUG', 'description': '(Panel 7 - 150 mg) - Oral Solution, Oral, once, 14 days', 'armGroupLabels': ['BMS-866949 (Panel 7)']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '(Matching volume) - Oral Solution, Oral, once 14 days', 'armGroupLabels': ['BMS-866949 (Panel 1)', 'BMS-866949 (Panel 2)', 'BMS-866949 (Panel 3)', 'BMS-866949 (Panel 4)', 'BMS-866949 (Panel 5)', 'BMS-866949 (Panel 6)', 'BMS-866949 (Panel 7)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '751 23', 'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Local Institution', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Study Director', 'oldOrganization': 'Bristol-Myers Squibb'}}}}