Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-31 @ 4:48 PM
Study NCT ID:
NCT00824057
Status:
COMPLETED
Last Update Posted:
2009-07-31
First Post:
2009-01-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C584463', 'term': '4-amino-8-(2,5-dimethoxyphenyl)-N-propylcinnoline-3-carboxamide'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-07-30', 'studyFirstSubmitDate': '2009-01-13', 'studyFirstSubmitQcDate': '2009-01-15', 'lastUpdatePostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-16', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "To determine the effects of repeated doses of AZD6280 on the pharmacokinetic profile of a CYP3A4 substrate (midazolam and its 1' hydroxy metabolite) and a CYP1A2 substrate (caffeine and its paraxanthine [3-desmethyl] metabolite).", 'timeFrame': 'Blood samples will be taken throughout the 19-day inpatient period of the study.'}], 'secondaryOutcomes': [{'measure': 'To evaluate the safety and tolerability of repeated doses of AZD6280 in combination with midazolam and caffeine.', 'timeFrame': 'Observations taken post dosing.'}, {'measure': 'Evaluation of the pharmacodynamic effects of AZD6280', 'timeFrame': 'Test batteries will be performed before and following study drug administration.'}, {'measure': 'To evaluate the pharmacokinetics of AZD6280', 'timeFrame': 'Blood samples will be taken throughout the 19-day inpatient period of the study.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Phase I'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the effects of taking repeated doses of AZD6280 on the blood levels of midazolam and caffeine in healthy volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subjects aged 18 to 45 years (inclusive) on Day 1.\n\nExclusion Criteria:\n\n* Clinically relevant abnormalities in physical examinations, vital signs, clinical chemistry, hematology or urinalysis as judged by the investigator and/or sponsor.\n* Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months or intake of an investigational drug within a period of 5 half lives of that drug prior to the screening visit'}, 'identificationModule': {'nctId': 'NCT00824057', 'acronym': 'CYP', 'briefTitle': 'Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I Open-labeled, Fixed Sequence Study to Determine the Effect of Multiple Doses of AZD6280 on the Pharmacokinetics of Midazolam (CYP3A4) and Caffeine (CYP1A2)', 'orgStudyIdInfo': {'id': 'D0850C00015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'interventionNames': ['Drug: AZD6280', 'Drug: Midazolam', 'Drug: Caffeine']}], 'interventions': [{'name': 'AZD6280', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['1']}, {'name': 'Midazolam', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['1']}, {'name': 'Caffeine', 'type': 'DRUG', 'description': 'oral', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'London', 'country': 'United Kingdom', 'facility': 'Research Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'overallOfficials': [{'name': 'Darren Wilbraham, MBBS, DCPSA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Guy's Drug Research Unit Quintiles Ltd"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark A. Smith, MD, PhDMedical Science Sr.Director', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}