Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2025-12-27 @ 8:01 AM
Study NCT ID:
NCT00886366
Status:
TERMINATED
Last Update Posted:
2010-12-07
First Post:
2009-04-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'whyStopped': 'Part A reached a predefined stopping criteria. Relevant doses for part B could not be established based on A and subsequently study was stopped.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-06', 'studyFirstSubmitDate': '2009-04-17', 'studyFirstSubmitQcDate': '2009-04-21', 'lastUpdatePostDateStruct': {'date': '2010-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety variables (AE, BP, pulse, plasma glucose, laboratory variables and ECG)', 'timeFrame': 'AEs will be collected during the whole study period (1-3 months). The other variables will be measured repeatedly during 24 hours on the study day sessions'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetic variables', 'timeFrame': 'Blood samples taken repeatedly during 24 hours on study day sessions.'}, {'measure': 'Pharmacodynamic variables (P-Glucose, S-Insulin and C-peptide)', 'timeFrame': 'Blood samples taken repeatedly during 24 hours on study day sessions.'}]}, 'conditionsModule': {'keywords': ['Type II Diabetes'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess safety and tolerability of AZD6714 after single ascending oral doses in healthy male subjects and type 2 diabetic patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Part A,Healthy male subjects, aged between ≥20 and ≤40 years.\n* Part B,Male T2DM patients, aged between ≥20 and ≤65 years. Treatment with metformin as single therapy for T2DM for at least 30 days prior to enrollment\n\nExclusion Criteria:\n\n* Part A,Clin sign illness or clin relevant trauma, as judged by the investigator, within 2 weeks before the first administration of the IP.\n* Part A Clin sign abnormalities in clinical chemistry, haematology, or urinalysis results as judged by the investigator\n* Part B, History of ischemic heart disease, symptomatic heart failure, stroke, transitory ischemic attack or symptomatic peripheral vascular disease.\n* Any clinically significant abnormality identified on physical examination, laboratory tests or ECG, which in the judgment of the investigator would compromise the patient's safety or successful participation."}, 'identificationModule': {'nctId': 'NCT00886366', 'briefTitle': 'Single Ascending Dose Study With Healthy Male Volunteers and Type II Diabetic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Single-Blind, Placebo-Controlled, Single-Centre, Phase I Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Food Interaction After Single Ascending Oral Doses of AZD6714 in Healthy Male Volunteers and Male Type II Diabetic Patients', 'orgStudyIdInfo': {'id': 'D1920C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'AZD6714 in 8 increasing oral single doses a-h given to 8 groups (3 on active and 1 on placebo in each group)', 'interventionNames': ['Drug: AZD6714', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': '2 oral single doses d and g suspensions of AZD6714 given to 2 groups (3+1) together with food', 'interventionNames': ['Drug: Placebo', 'Drug: AZD6714']}, {'type': 'EXPERIMENTAL', 'label': '3', 'description': 'Two increasing oral doses of AZD6714 and one placebo given to 2 groups with 3 type 2 diabetic patients.', 'interventionNames': ['Drug: Placebo', 'Drug: AZD6714']}], 'interventions': [{'name': 'AZD6714', 'type': 'DRUG', 'description': 'Oral single doses a-h suspension', 'armGroupLabels': ['1']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral single doses suspension', 'armGroupLabels': ['1', '2', '3']}, {'name': 'AZD6714', 'type': 'DRUG', 'description': 'Oral single doses a-d suspension', 'armGroupLabels': ['3']}, {'name': 'AZD6714', 'type': 'DRUG', 'description': 'Oral single doses d and g suspension', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Research Site', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Klas Malmberg, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca R&D Mölndal'}, {'name': 'Marianne Hartford', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CPU Sahlgrenska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Klas Malmberg, MD, PhD, Prof. Medical Science Director', 'oldOrganization': 'AstraZeneca Pharmaceuticals'}}}}