Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT00817505
Status:
COMPLETED
Last Update Posted:
2009-11-03
First Post:
2008-12-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Bioavailability of a Tablet of AZD1656
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C576407', 'term': 'AZD1656'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-11', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-11-02', 'studyFirstSubmitDate': '2008-12-24', 'studyFirstSubmitQcDate': '2009-01-05', 'lastUpdatePostDateStruct': {'date': '2009-11-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic variables ( Area under the plasma concentration vs. time curve (AUC), maximum plasma concentration (Cmax), time to reach maximum plasma concentration (tmax), terminal elimination half-life (t½) and apparent oral clearance (CL/F)', 'timeFrame': 'Blood samples taken up to 72 hours'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamic variables (Plasma glucose)', 'timeFrame': 'Taken repeatedly during treatment periods'}, {'measure': 'Safety Variables (AEs, BP, pulse, electrocardiogram (ECG), hypoglycaemic symptoms and laboratory variables)', 'timeFrame': 'Taken during treatment periods'}]}, 'conditionsModule': {'keywords': ['Type I diabetes', 'bioavailability'], 'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'To evaluate the bioavailability of a tablet of AZD1656.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, type I diabetes patients, female with non child-bearing potential.\n* Treated with insulin for more than 3 years. Well controlled HbA1c.\n* Have a body mass index (BMI) ≥19 and ≤35\n\nExclusion Criteria:\n\n* Clinically significant illness except type I diabetes, or clinically relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the investigational product\n* Daily use of nicotine containing substances.'}, 'identificationModule': {'nctId': 'NCT00817505', 'briefTitle': 'To Evaluate the Bioavailability of a Tablet of AZD1656', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Open, Single-Dose, Single-Centre, Cross-over, Phase I Study in Type 1 Diabetes Mellitus Patients to Estimate the Extent and Rate of Absorption of AZD1656 After Administration of a Tablet Formulation in the Fasting State and Just Before Food in Comparison With an Oral Suspension of AZD1', 'orgStudyIdInfo': {'id': 'D1020C00010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'AZD1656 tablet + food', 'interventionNames': ['Drug: AZD1656']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'AZD1656 susp. without food', 'interventionNames': ['Drug: AZD1656']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'AZD1656 tablet', 'interventionNames': ['Drug: AZD1656']}], 'interventions': [{'name': 'AZD1656', 'type': 'DRUG', 'description': 'Single dose oral tablet', 'armGroupLabels': ['1', '2', '3']}, {'name': 'AZD1656', 'type': 'DRUG', 'description': 'Single dose oral suspension', 'armGroupLabels': ['1', '2', '3']}]}, 'contactsLocationsModule': {'locations': [{'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Klas Malmberg, MD, PhD, Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Mölndal'}, {'name': 'Emanuel P DeNoia, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Healthcare Discoveries LLC Icon Development Solutions'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Klas Malmberg, MD, PhD, Prof. Medical Science Director, Emerging Products', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}