Ignite Creation Date:
2025-12-25 @ 3:28 AM
Ignite Modification Date:
2025-12-26 @ 2:09 AM
Study NCT ID:
NCT04951505
Status:
COMPLETED
Last Update Posted:
2025-06-08
First Post:
2021-06-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects
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': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-04', 'studyFirstSubmitDate': '2021-06-28', 'studyFirstSubmitQcDate': '2021-06-28', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ELF Cmax', 'timeFrame': '0-8 hours after 6th dose', 'description': 'Maximum concentrations of cefepime and taniborbactam, determined directly from individual concentration-time data, in epithelial lining fluid (ELF)'}], 'secondaryOutcomes': [{'measure': 'Number of subjects with adverse events', 'timeFrame': 'Day 1 - Day 8'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Subjects']}, 'referencesModule': {'references': [{'pmid': '40476839', 'type': 'DERIVED', 'citation': 'Rodvold KA, Gotfried MH, Sabato P, Henkel T, McGovern PC. Plasma and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult participants. Antimicrob Agents Chemother. 2025 Jul 2;69(7):e0049325. doi: 10.1128/aac.00493-25. Epub 2025 Jun 6.'}]}, 'descriptionModule': {'briefSummary': 'This is a single-center, open-label study to assess the safety and intrapulmonary pharmacokinetics of cefepime and taniborbactam in healthy adult male and female subjects. Thirty subjects will receive a total of 6 doses of cefepime-taniborbactam (2 g cefepime/0.5g taniborbactam) administered intravenously every 8 hours. Following the sixth dose of cefepime-taniborbactam, subjects will be assigned to one of six bronchoscopy sampling times.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy adults 18-55 years\n2. Males or non-pregnant, non-lactating females\n3. Body mass index (BMI): ≥18 kg/m2 and ≤32.0 kg/m2, weight \\>50.0 kg.\n4. Must have negative alcohol, drug, or tobacco use/test and no use of alcohol, caffeine during the study\n\nExclusion Criteria:\n\n1. History or presence of current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorders\n2. History of drug allergy or hypersensitivity to penicillin, cephalosporin, or beta-lactam antibacterial drug\n3. Recent history of known or suspected Clostridioides difficile infection\n4. Abnormal ECG or history of clinically significant abnormal rhythm disorder\n5. Abnormal lab tests'}, 'identificationModule': {'nctId': 'NCT04951505', 'briefTitle': 'Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venatorx Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Safety and Intrapulmonary Pharmacokinetics of Cefepime and Taniborbactam in Healthy Subjects', 'orgStudyIdInfo': {'id': 'VNRX-5133-107'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'cefepime-taniborbactam', 'interventionNames': ['Drug: cefepime-taniborbactam']}], 'interventions': [{'name': 'cefepime-taniborbactam', 'type': 'DRUG', 'description': 'IV infusion', 'armGroupLabels': ['cefepime-taniborbactam']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85032', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pulmonary Associates PA', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venatorx Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}