Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-26 @ 11:10 PM
Study NCT ID:
NCT01254461
Status:
COMPLETED
Last Update Posted:
2011-04-29
First Post:
2010-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C569518', 'term': 'AZD1981'}, {'id': 'D017035', 'term': 'Pravastatin'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-28', 'studyFirstSubmitDate': '2010-12-03', 'studyFirstSubmitQcDate': '2010-12-03', 'lastUpdatePostDateStruct': {'date': '2011-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics for pravastatin measured by Cmax and AUC', 'timeFrame': 'Pharmacokinetic (PK) sampling will be performed on Day 1, period A and on Day 7-8, period B', 'description': 'Pharmacokinetics for pravastatin measured by Cmax and AUC'}], 'secondaryOutcomes': [{'measure': 'AUC', 'timeFrame': 'PK sampling will be performed on Day 1, period A and on Day 7-8, period B', 'description': 'Pharmacokinetics for pravastatin measured by AUC\\[0-t\\],Cmax (tmax), CL/F, t1/2λz, Vz/F, MRT'}, {'measure': 'AUCτ', 'timeFrame': 'PK sampling will be performed on Day 7 and Day 8, period B', 'description': 'Pharmacokinetics for AZD1981 measured by AUCτ,Css,max, Css, max (tmax ss), CLss/F, t1/2λz, Vz/F, MRT'}, {'measure': 'Safety and tolerability', 'timeFrame': 'Safety will be monitored continously and safety assessments will be made on several occasions throughout the whole study', 'description': 'Safety and tolerability of AZD1981'}]}, 'conditionsModule': {'keywords': ['Phase 1', 'Drug-Drug interaction', 'pravastatin', 'AZD1981', 'The pharmacokinetics resulting from AZD1981 and pravastatin interaction', 'The effects of taking a combination of AZD1981 and pravastatin'], 'conditions': ['Drug Interaction']}, 'descriptionModule': {'briefSummary': 'The primary purpose of this study is to determine whether the treatment with AZD1981 will affect the pharmacokinetics of pravastatin.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male volunteers aged 18 to 55, inclusive\n* Have a body mass index between 19 and 30 kg/m2 and weight at least 50 kg and no more than 100 kg, inclusive\n* Be a non-smoker or ex-smoker who has stopped smoking for \\>6 months prior to screening\n* Volunteers must be willing to use barrier methods of contraception during study and 3 months after the end of their participation in the study\n\nExclusion Criteria:\n\n* Any clinically significant disease or disorder\n* Any clinically relevant abnormal findings in physical examination'}, 'identificationModule': {'nctId': 'NCT01254461', 'briefTitle': 'A Drug-Drug Interaction Study Between AZD1981 and Pravastatin to Study the Effect of AZD1981 on the Kinetics of Pravastatin', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase I, Open Label, Randomised, Parallel Group Study of Repeated Oral Doses of AZD1981 (100 mg Twice Daily and 400 mg Twice Daily Via Tablet) for Eight Days and Single Doses of Pravastatin (Pravachol® Tablet 40 mg) to Evaluate the Pharmacokinetic Interaction of AZD1981 and Pravastatin in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'D9830C00016'}, 'secondaryIdInfos': [{'id': '2010-023876-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'interventionNames': ['Drug: AZD1981', 'Drug: pravastatin']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'interventionNames': ['Drug: AZD1981', 'Drug: pravastatin']}], 'interventions': [{'name': 'AZD1981', 'type': 'DRUG', 'description': '100 mg per oral, twice daily for 8 days', 'armGroupLabels': ['A']}, {'name': 'AZD1981', 'type': 'DRUG', 'description': '4x100 mg per oral, twice daily for 8 days', 'armGroupLabels': ['B']}, {'name': 'pravastatin', 'type': 'DRUG', 'otherNames': ['pravachol'], 'description': '40 mg, once daily at Day 1, period A and Day 8, period B', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Uppsala', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 59.85882, 'lon': 17.63889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Christer Hultquist/Medical Science Director', 'oldOrganization': 'AstraZeneca R&D'}}}}