Ignite Creation Date:
2025-12-26 @ 2:42 PM
Ignite Modification Date:
2025-12-26 @ 2:42 PM
Study NCT ID:
NCT00736606
Status:
COMPLETED
Last Update Posted:
2010-12-02
First Post:
2008-08-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Sweden']}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'C000608601', 'term': 'AZD9056'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-30', 'studyFirstSubmitDate': '2008-08-15', 'studyFirstSubmitQcDate': '2008-08-15', 'lastUpdatePostDateStruct': {'date': '2010-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK variables', 'timeFrame': 'Frequent sampling occasions during study periods'}], 'secondaryOutcomes': [{'measure': 'Safety variables (adverse events, blood pressure, pulse, safety lab)', 'timeFrame': 'During the whole treatment periods'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['simvastatin', 'AZD5672'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the pharmacokinetics of both AZD9056 (steady state) and simvastatin (single dose) when co-administered in healthy volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of informed consent prior to any study specific procedures.\n* Male or female healthy subjects. Females should not be of childbearing potential\n* Clinically normal physical and laboratory findings as judged by the investigator, including negative test results for drug-of-abuse, alcohol and cotinine at the Screening Visit and/or admission (Day -1) of each study period, and negative test results\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subject's ability to participate\n* Known allergy to simvastatin (or other statins) or previous complications to simvastatin therapy.\n* Participation in a clinical study involving an investigational product within 5 half-lives of active moieties of the last dose of investigational product or 3 months prior to first dosing (whichever is longer)."}, 'identificationModule': {'nctId': 'NCT00736606', 'briefTitle': 'A Study to Assess Co-Administered AZD9056 (Steady State) and Simvastatin (Single Dose) in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Single Centre, Open-Label Study to Assess the Pharmacokinetics of Both AZD9056 (Steady State) and Simvastatin (Single Dose) When Co-Administered in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'D1520C00008'}, 'secondaryIdInfos': [{'id': 'EudraCt nr 2008-003626-41'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Period 1', 'description': 'simvastatin', 'interventionNames': ['Drug: simvastatin']}, {'type': 'EXPERIMENTAL', 'label': 'Period 2', 'description': 'simvastatin + AZD9056', 'interventionNames': ['Drug: AZD9056 + simvastatin']}], 'interventions': [{'name': 'simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'One single dose of 40mg', 'armGroupLabels': ['Period 1']}, {'name': 'AZD9056 + simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'AZD9056: 400 mg od, 8 days simvastatin: one single dose of 40 mg on day 7', 'armGroupLabels': ['Period 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Rod Hepburn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D, Charnwood, UK'}, {'name': 'Maura Fallon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PAREXEL Clinical Pharmacology Research Unit'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Mark Layton, MD, PhD, Medical Science Director', 'oldOrganization': 'AstraZeneca R&D Alderely Park'}}}}