Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT01039194
Status:
COMPLETED
Last Update Posted:
2011-01-25
First Post:
2009-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005702', 'term': 'Galantamine'}, {'id': 'C554092', 'term': 'BMS 708163'}], 'ancestors': [{'id': 'D047151', 'term': 'Amaryllidaceae Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-02', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-01-24', 'studyFirstSubmitDate': '2009-12-22', 'studyFirstSubmitQcDate': '2009-12-23', 'lastUpdatePostDateStruct': {'date': '2011-01-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Galantamine alone and with BMS-708163: Galantamine PK parameters (Cmax, Tmax, AUC(TAU) and Ctrough rations will be assessed without BMS-708163 Day 14) and with BMS708-163 (Ctrough Day 24)', 'timeFrame': 'Study Days 14 & 24'}], 'secondaryOutcomes': [{'measure': "Galantamine alone and with BMS 708163: Safety and tolerability (AE's, ECG, vital signs, safety labs)", 'timeFrame': 'Study Days 7, 14, 18, 25 and study discharge'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx', 'label': 'Investigator Inquiry form'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to find out if the plasma concentration of galantamine extended release is changed when BMS-708163 is administered at the same time.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy men and postmenopausal women\n\nExclusion Criteria:\n\n* Gastrointestinal disorders\n* Bleeding disorders\n* Peptic ulcer disease\n* Cholecystectomy\n* Seizure disorder\n* Asthma\n* Chronic obstructive pulmonary disease\n* Urinary tract obstruction\n* Cardiac conduction abnormalities, including but not limited to "sick sinus syndrome" and those with unexplained syncopal episodes\n* Inability to tolerate oral medication\n* Inability to be venipunctured and/or tolerate venous access'}, 'identificationModule': {'nctId': 'NCT01039194', 'briefTitle': 'Drug-Drug Interaction to Study the Effect of BMS-708163 on Pharmacokinetics (PK) of Galantamine Extended Release (ER)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'A Study of the Effect of Concomitant Administration of Multiple Doses of BMS-708163 on the Pharmacokinetics of Galantamine in Healthy Subjects', 'orgStudyIdInfo': {'id': 'CN156-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'galantamine 8 mg (ER)', 'interventionNames': ['Drug: galantamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'galantamine 16 mg (ER)', 'interventionNames': ['Drug: galantamine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'BMS-708163', 'interventionNames': ['Drug: BMS-708163']}], 'interventions': [{'name': 'galantamine', 'type': 'DRUG', 'otherNames': ['Razadyne ER ™'], 'description': 'Capsule, Oral, 8 mg (ER), once daily, Days 1-7', 'armGroupLabels': ['galantamine 8 mg (ER)']}, {'name': 'galantamine', 'type': 'DRUG', 'otherNames': ['Razadyne ER ™'], 'description': 'Capsule, Oral, 16 mg (ER), once daily, Days 8-24', 'armGroupLabels': ['galantamine 16 mg (ER)']}, {'name': 'BMS-708163', 'type': 'DRUG', 'description': 'Capsule, Oral, 125 mg, once daily, Days 15-24', 'armGroupLabels': ['BMS-708163']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21225', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Parexel International - Baltimore Epcu', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], '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'}}}}