Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-28 @ 9:06 AM
Study NCT ID:
NCT01017666
Status:
COMPLETED
Last Update Posted:
2023-08-23
First Post:
2009-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C547274', 'term': '3-(4-amino-3-methylbenzyl)-7-(2-furyl)-3H-(1,2,3)triazolo(4,5-d)pyrimidine-5-amine'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2010-06-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2009-11-16', 'studyFirstSubmitQcDate': '2009-11-19', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic profile of rosiglitazone (Cohort 1), midazolam & metabolites and s-warfarin (Cohort 2) during steady state exposure to BIIB014 or placebo', 'timeFrame': '24 hours (Cohort 1); 144 hours (Cohort 2)'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': 'Duration of subject participation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Healthy Volunteer'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to understand whether BIIB014 has potential to affect how certain drugs are broken down by the body.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male or female subjects\n* Between the ages of 18 and 45, inclusive.\n* Must have a body mass index (BMI) between 19 kg/m2 and 30 kg/m2, inclusive\n\nExclusion Criteria:\n\n* Clinically significant abnormalities (as determined by the Investigator)\n* Other unspecified reason that would make the subject unsuitable for enrollment (as determined by the Investigator)'}, 'identificationModule': {'nctId': 'NCT01017666', 'briefTitle': 'BIIB014 Effects on the Pharmacokinetics (PK) of Rosiglitazone, Warfarin, and Midazolam', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Assess the Effect of BIIB014 on the Pharmacokinetics of Rosiglitazone, Warfarin, and Midazolam in Healthy Volunteers', 'orgStudyIdInfo': {'id': '204HV103'}, 'secondaryIdInfos': [{'id': 'EUDRA CT 2009-014259-60'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosiglitazone 8mg PO', 'description': 'Cohort 1', 'interventionNames': ['Drug: BIIB014', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Midazolam 2mg PO, Warfarin 25mg PO', 'description': 'Cohort 2', 'interventionNames': ['Drug: BIIB014', 'Drug: Placebo']}], 'interventions': [{'name': 'BIIB014', 'type': 'DRUG', 'description': 'BIIB014 100mg PO Cohort 1 - 8d Cohort 2 - 14d', 'armGroupLabels': ['Midazolam 2mg PO, Warfarin 25mg PO', 'Rosiglitazone 8mg PO']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matched placebo to BIIB014 Cohort 1 - 8d Cohort 2 - 14d', 'armGroupLabels': ['Midazolam 2mg PO, Warfarin 25mg PO', 'Rosiglitazone 8mg PO']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E14NL', 'city': 'London', 'country': 'United Kingdom', 'facility': 'InCROM Clinical Research Unit', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biogen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}