Ignite Creation Date:
2025-12-25 @ 1:16 AM
Ignite Modification Date:
2025-12-31 @ 5:58 PM
Study NCT ID:
NCT00719693
Status:
COMPLETED
Last Update Posted:
2012-09-28
First Post:
2008-07-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of the Effect of Food on ABT-143 Bioavailability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'C006012', 'term': 'fenofibric acid'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 115}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-27', 'studyFirstSubmitDate': '2008-07-18', 'studyFirstSubmitQcDate': '2008-07-21', 'lastUpdatePostDateStruct': {'date': '2012-09-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '30 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Food effect, phase I', 'adverse events'], 'conditions': ['Pharmacokinetic Variables']}, 'descriptionModule': {'briefSummary': 'Single-dose, open-label, two-period crossover study of ABT-143'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-55 years of age (inclusive)\n* BMI 19 to 29 inclusive\n\nExclusion Criteria:\n\n* Asian ancestry\n* Concurrent participation in another study\n* Females pregnant or breastfeeding'}, 'identificationModule': {'nctId': 'NCT00719693', 'briefTitle': 'Assessment of the Effect of Food on ABT-143 Bioavailability', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'orgStudyIdInfo': {'id': 'M10-442'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'ABT-143 under low-fat meal condition', 'interventionNames': ['Drug: ABT-143 ( rosuvastatin calcium and fenofibric acid )']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'ABT-143 under fasting meal condition', 'interventionNames': ['Drug: ABT-143 (rosuvastatin calcium and fenofibric acid )']}], 'interventions': [{'name': 'ABT-143 ( rosuvastatin calcium and fenofibric acid )', 'type': 'DRUG', 'otherNames': ['ABT-143', 'fenofibric acid/rosuvastatin calcium'], 'description': 'one dose under low-fat meal condition', 'armGroupLabels': ['A']}, {'name': 'ABT-143 (rosuvastatin calcium and fenofibric acid )', 'type': 'DRUG', 'description': 'one dose under fasting meal condition', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47710', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Site Reference ID/Investigator# 9242', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}], 'overallOfficials': [{'name': 'Torbjörn Lundström, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}