Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-25 @ 5:27 PM
Study NCT ID:
NCT03554304
Status:
COMPLETED
Last Update Posted:
2018-06-13
First Post:
2018-05-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624485', 'term': 'cefepime-zidebactam'}, {'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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-30', 'studyFirstSubmitDate': '2018-05-16', 'studyFirstSubmitQcDate': '2018-05-30', 'lastUpdatePostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of delay in cardiac repolarization induced by WCK 5222', 'timeFrame': '0-4 days', 'description': 'as shown by analysis of the QT interval.'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events to assess tolerability at the supratherapeutic dose to be used in the thorough QT evaluation', 'timeFrame': '0-4 days', 'description': 'Tolerability will be assessed by review of number of AEs'}, {'measure': 'Incidence of AEs to assess the safety of high doses of single-dose administration of FEP-ZID', 'timeFrame': '0-4 days', 'description': 'Safety will be assessed by review of adverse events (AEs), ECGs, and clinical laboratory safety test results'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['QT/QTc Interval in Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Body mass index ≥18 to ≤33 kg/m2, inclusive.\n2. Stable health based on a medical history without any major pathology/surgery in the 6 months\n\nExclusion Criteria:\n\n1. An uninterpretable or abnormal screening electrocardiogram (ECG) indicating a second- or third-degree atrioventricular block\n2. History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypocalcemia, or hypomagnesemia.\n3. A sustained supine systolic blood pressure \\>150 mm Hg or \\<90 mm Hg or a supine diastolic blood pressure \\>95 mm Hg or \\<50 mm Hg at Screening or Check-in (Day -1).'}, 'identificationModule': {'nctId': 'NCT03554304', 'briefTitle': 'Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wockhardt'}, 'officialTitle': 'A Randomized, Double-Blind, Double-Dummy, Placebo- and Positive-Controlled, Crossover Study to Evaluate the Effect of WCK 5222 on the QT/QTc Interval in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'W-5222-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'WCK 5222', 'description': 'WCK 5222 IV solution administered as either a 30- or 60-minute IV infusion)', 'interventionNames': ['Drug: WCK 5222', 'Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (IV placebo matched toWCK 5222IV solution)', 'description': 'placebo capsule matched to moxifloxacin overencapsulated tablet IV placebo matched to WCK 5222 IV solution', 'interventionNames': ['Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Moxifloxacin 400-mg', 'description': 'positive control', 'interventionNames': ['Drug: IV placebo matched to WCK 5222 / Moxifloxacin IV solution', 'Drug: Moxifloxacin 400-mg']}], 'interventions': [{'name': 'WCK 5222', 'type': 'DRUG', 'description': 'FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)', 'armGroupLabels': ['WCK 5222']}, {'name': 'IV placebo matched to WCK 5222 / Moxifloxacin IV solution', 'type': 'DRUG', 'otherNames': ['Placebo capsule matched to moxifloxacin'], 'description': 'Placebo (IV placebo matched to FEP-ZID IV solution) and\n\n1 placebo capsule matched to moxifloxacin overencapsulated tablet', 'armGroupLabels': ['Moxifloxacin 400-mg', 'Placebo (IV placebo matched toWCK 5222IV solution)', 'WCK 5222']}, {'name': 'Moxifloxacin 400-mg', 'type': 'DRUG', 'description': 'Moxifloxacin 400-mg positive control (overencapsulated tablet)', 'armGroupLabels': ['Moxifloxacin 400-mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53095', 'city': 'West Bend', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Spaulding Clinical Research', 'geoPoint': {'lat': 43.42528, 'lon': -88.18343}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wockhardt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}