Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-02-25 @ 5:54 PM
Study NCT ID:
NCT03630094
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2017-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plasma and Intrapulmonary Concentrations Study of WCK 5222
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-07-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-13', 'studyFirstSubmitDate': '2017-03-17', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'concentrations of cefepime (FEP) and zidebactam in epithelial lining fluid (ELF)', 'timeFrame': 'Day 3'}, {'measure': 'concentrations of cefepime (FEP) and zidebactam in alveolar macrophage (AM)', 'timeFrame': 'Day 3'}], 'secondaryOutcomes': [{'measure': 'Number of adverse event reported', 'timeFrame': 'Day 3'}, {'measure': 'number variation noted in 12-lead electrocardiogram', 'timeFrame': 'Day 3'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PHA1A']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, multiple dose, open-label pharmacokinetic study in healthy adult male and female subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) greater than or equal to18.5 and less than or equal to 30 (kg per m2) and weight between 55.0 and 100.0 kg (both inclusive).\n* Medical history without any major pathology as judged by the Investigator.\n* Forced expiratory volume in 1 second (FEV1) of at least 70% of predicted value at screening.\n\nExclusion Criteria:\n\n* History or presence of significant oncologic, cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal,endocrine, immunologic, dermatologic, neurological, or psychiatric disease.\n* Positive alcohol breath test or urine drug screen test at screening or confinement.\n* Current use or has used tobacco or nicotine containing products 6 month prior to screening.\n* Positive testing for HIV, Hepatitis B or Hepatitis C.\n* History or presence of alcohol or drug abuse within the 2 years prior to screening.'}, 'identificationModule': {'nctId': 'NCT03630094', 'briefTitle': 'Plasma and Intrapulmonary Concentrations Study of WCK 5222', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wockhardt'}, 'officialTitle': 'A Phase 1, Multiple-Dose, Open-Label Study to Determine and Compare Plasma and Intrapulmonary Concentrations of WCK 5222 (Cefepime and Zidebactam) in Healthy Adult Human Subjects', 'orgStudyIdInfo': {'id': 'W-5222-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FEP-ZID via intravenous', 'description': 'total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen', 'interventionNames': ['Drug: FEP-ZID']}], 'interventions': [{'name': 'FEP-ZID', 'type': 'DRUG', 'description': 'A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen', 'armGroupLabels': ['FEP-ZID via intravenous']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wockhardt', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}