Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-27 @ 11:51 AM
Study NCT ID:
NCT00434395
Status:
COMPLETED
Last Update Posted:
2019-11-25
First Post:
2007-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-21', 'studyFirstSubmitDate': '2007-02-09', 'studyFirstSubmitQcDate': '2007-02-12', 'lastUpdatePostDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-02-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cardiac repolarization will be assessed by the QTc interval in healthy subjects.'}]}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the effects of MOA-728 on cardiac repolarization in healthy subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy subjects men or women aged 18-50\n\nExclusion Criteria:\n\n* Any significant clinically important disease\n* Family history of long QT syndrome and/or sudden cardiac death\n* Allergy to moxifloxacin or the quinolone class of antibiotics'}, 'identificationModule': {'nctId': 'NCT00434395', 'briefTitle': 'Study Evaluating the Effects of MOA-728 on Cardiac Repolarization in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bausch Health Americas, Inc.'}, 'officialTitle': 'A Randomized, Double-Blind, Placebo- and Moxifloxacin (Open-Label)-Controlled, 4-Period Crossover Study of the Effects of a Single Dose of MOA-728 Infused Intravenously on Cardiac Repolarization in Healthy Subjects', 'orgStudyIdInfo': {'id': '3200L2-104'}}, 'armsInterventionsModule': {'interventions': [{'name': 'MOA-728', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85044', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}], 'overallOfficials': [{'name': 'Jeff Cohn', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bausch Health Americas, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bausch Health Americas, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Jeff Cohn', 'oldOrganization': 'Salix Pharmaceuticals'}}}}