Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2025-12-25 @ 11:28 PM
Study NCT ID:
NCT00688493
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2008-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Single Oral Dose Dapagliflozin QT Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C529054', 'term': 'dapagliflozin'}, {'id': 'D000077266', 'term': 'Moxifloxacin'}], 'ancestors': [{'id': 'D024841', 'term': 'Fluoroquinolones'}, {'id': 'D042462', 'term': '4-Quinolones'}, {'id': 'D015363', 'term': 'Quinolones'}, {'id': 'D011804', 'term': 'Quinolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-20', 'studyFirstSubmitDate': '2008-05-30', 'studyFirstSubmitQcDate': '2008-06-02', 'lastUpdatePostDateStruct': {'date': '2012-03-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-06-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Electronic measures of heart beats', 'timeFrame': 'ECGs (electronic measures of the heart) are taken at scheduled times during the 3 days after receiving each dose of study medication'}], 'secondaryOutcomes': [{'measure': 'Blood levels of dapagliflozin following single 20 mg and 150 mg doses in healthy volunteers', 'timeFrame': 'At scheduled times during the 3 day periods following dosing during each of the 4 study periods'}, {'measure': 'Safety and tolerability of dapagliflozin', 'timeFrame': 'Screening through completion of the study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['QT', 'Healthy volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The main purpose of this study is to examine the effect of dapagliflozin on electronic measures of heart beats in healthy males'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males age 18 to 45 years of age, who are not currently taking any medications\n* Normal screening results including a physical examination, laboratory tests, heart rate, blood pressure, and ECG (electronic measure of the heart)\n\nExclusion Criteria:\n\n* No personal or family history of significant heart problems\n* No use of over the counter medications within 7 days of the study\n* No use of prescription medicaiton within 1 month of the study'}, 'identificationModule': {'nctId': 'NCT00688493', 'briefTitle': 'Effects of Single Oral Dose Dapagliflozin QT Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Double-blind, Randomized, Four-period Crossover Study to Assess the Effects of Single Oral Dose Dapagliflozin Administration on QTc Interval Compared to Placebo, Using AVELOX™ (Moxifloxacin) as a Positive Control, in Healthy Male Volunteers Age 18 to 45 Years', 'orgStudyIdInfo': {'id': 'D1690C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '20 mg single dose of dapagliflozin', 'description': '20 mg dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Moxifloxacin', 'Drug: Placebo to match moxifloxacin and dapagliflozin']}, {'type': 'EXPERIMENTAL', 'label': '150 mg single dose of dapagliflozin2', 'description': '150 mg dapagliflozin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Moxifloxacin', 'Drug: Placebo to match moxifloxacin and dapagliflozin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '400 mg single dose of moxifloxacin', 'description': 'Moxifloxacin', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Moxifloxacin', 'Drug: Placebo to match moxifloxacin and dapagliflozin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo', 'interventionNames': ['Drug: Dapagliflozin', 'Drug: Moxifloxacin', 'Drug: Placebo to match moxifloxacin and dapagliflozin']}], 'interventions': [{'name': 'Dapagliflozin', 'type': 'DRUG', 'description': '3 x 50 mg tablets, single oral dose', 'armGroupLabels': ['150 mg single dose of dapagliflozin2', '20 mg single dose of dapagliflozin', '400 mg single dose of moxifloxacin', 'Placebo']}, {'name': 'Dapagliflozin', 'type': 'DRUG', 'description': '2 x 10 mg capsules, single oral dose', 'armGroupLabels': ['150 mg single dose of dapagliflozin2', '20 mg single dose of dapagliflozin', '400 mg single dose of moxifloxacin', 'Placebo']}, {'name': 'Moxifloxacin', 'type': 'DRUG', 'otherNames': ['Avelox™'], 'description': 'Overencapsulated 400 mg capsule, single oral dose', 'armGroupLabels': ['150 mg single dose of dapagliflozin2', '20 mg single dose of dapagliflozin', '400 mg single dose of moxifloxacin', 'Placebo']}, {'name': 'Placebo to match moxifloxacin and dapagliflozin', 'type': 'DRUG', 'description': 'Overencapsulated 400 mg capsule, single oral dose', 'armGroupLabels': ['150 mg single dose of dapagliflozin2', '20 mg single dose of dapagliflozin', '400 mg single dose of moxifloxacin', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Glenn Carlson, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Ronald Goldwater, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Parexel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}