Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-30 @ 3:46 AM
Study NCT ID:
NCT03332732
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2017-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001424', 'term': 'Bacterial Infections'}], 'ancestors': [{'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707821', 'term': 'taniborbactam'}, {'id': 'D008795', 'term': 'Metronidazole'}], 'ancestors': [{'id': 'D009593', 'term': 'Nitroimidazoles'}, {'id': 'D009574', 'term': 'Nitro Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-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': 'SEQUENTIAL', 'interventionModelDescription': 'Part 1: Cross-over Part 2: Parallel'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-17', 'studyFirstSubmitDate': '2017-09-28', 'studyFirstSubmitQcDate': '2017-11-01', 'lastUpdatePostDateStruct': {'date': '2018-10-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Bactericidal titers (Part 2)', 'timeFrame': '10 days', 'description': 'To evaluate serum and urine bactericidal activity at peak and trough concentrations following multiple dose administration of VNRX-5133 + VNRX-5022'}], 'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)', 'timeFrame': '0-48 hours', 'description': 'Cmax'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of VNRX-5133 and VNRX-5022 following single doses alone and in combination (Part 1A)', 'timeFrame': '0-48 hours', 'description': 'AUCinf'}], 'secondaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)', 'timeFrame': '0-48 hours', 'description': 'Cmax'}, {'measure': 'Area under the plasma concentration versus time curve (AUC) of metronidazole, VNRX-5133, and VNRX-5022 (Part 1B)', 'timeFrame': '0-48 hours', 'description': 'AUCinf'}, {'measure': 'Number of Subjects with Treatment Emergent Adverse Events', 'timeFrame': 'First dose to 7 days after last dose: Part 1: 20 days / Part 2: 17 days', 'description': 'TEAEs based on patient reporting, physical exams, collection of vital signs, ECGs and absolute values and changes over time of hematology, chemistry and urinalysis.'}, {'measure': 'Accumulation of VNRX-5133 + VNRX-5022 following multiple dose administration', 'timeFrame': 'Part 2: 10 days', 'description': 'Trough concentration levels from Day 1 - Day 10'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Healthy Volunteers', 'Pharmacokinetics'], 'conditions': ['Bacterial Infections']}, 'descriptionModule': {'briefSummary': 'This is a 2-part, drug-drug interaction study to evaluate potential PK interactions after single doses in Part 1 and multiple doses in Part 2. In Part 1, subjects will receive single dose of 5 treatments in a cross-over design; in Part 2 subjects will receive treatment for 10 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults\n* Males or non-pregnant, non-lactating females\n* Body Mass Index (BMI) between 18.5 - 32.0, inclusive\n* Weight greater than or equal to 50 kg\n* Suitable veins for cannulation\n\nExclusion Criteria:\n\n* Employee of site or the sponsor\n* Any disease that poses an unacceptable risk to participants\n* Abnormal ECG\n* Abnormal labs\n* Abnormal vital signs\n* Current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, autoimmune, hematologic, neoplastic, or neurological disorder\n* Positive serology for hepatitis B surface antigen, hepatitis C antibody, or human immunodeficiency virus (HIV) type 1'}, 'identificationModule': {'nctId': 'NCT03332732', 'briefTitle': 'VNRX-5133 Drug-Drug Interaction in Healthy Adult Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Venatorx Pharmaceuticals, Inc.'}, 'officialTitle': 'VNRX-5133-103: A Randomized, Drug-Drug Interaction Study to Assess the Safety and Pharmacokinetics of VNRX-5133 in Healthy Adult Volunteers', 'orgStudyIdInfo': {'id': 'VNRX-5133-103'}, 'secondaryIdInfos': [{'id': '272201300019C-3-0-1', 'link': 'https://reporter.nih.gov/quickSearch/272201300019C-3-0-1', 'type': 'NIH'}, {'id': '17-0068', 'type': 'OTHER', 'domain': 'DMID'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1A', 'description': 'In Part 1A, subjects will receive single doses of VNRX-5133 and VNRX-5022 alone and in combination. All subjects will receive all treatments in the sequence specified by the randomization schedule..', 'interventionNames': ['Drug: VNRX-5133', 'Drug: VNRX-5022']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1B', 'description': 'In part 1B, subjects from Part 1A will receive metronidazole with or without VNRX-5133 + VNRX-5022. All subjects will receive all treatments in the sequence specified by the randomization schedule.', 'interventionNames': ['Drug: VNRX-5133', 'Drug: VNRX-5022', 'Drug: Metronidazole']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - 2A', 'description': 'Multiple dose administration of Low Dose VNRX-5133 + VNRX-5022', 'interventionNames': ['Drug: VNRX-5133', 'Drug: VNRX-5022']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2 - 2B', 'description': 'Multiple dose administration of High Dose VNRX-5133 + VNRX-5022', 'interventionNames': ['Drug: VNRX-5133', 'Drug: VNRX-5022']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Part 2 - 2C', 'description': 'Multiple dose administration of Placebo (matching VNRX-5133 + VNRX-5022)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'VNRX-5133', 'type': 'DRUG', 'description': 'β-lactamase inhibitor', 'armGroupLabels': ['Part 1A', 'Part 1B', 'Part 2 - 2A', 'Part 2 - 2B']}, {'name': 'VNRX-5022', 'type': 'DRUG', 'description': 'Approved β-lactam antibiotic', 'armGroupLabels': ['Part 1A', 'Part 1B', 'Part 2 - 2A', 'Part 2 - 2B']}, {'name': 'Metronidazole', 'type': 'DRUG', 'description': 'Approved antibiotic and antiprotozoal medication', 'armGroupLabels': ['Part 1B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (matching VNRX-5133 + VNRX-5022)', 'armGroupLabels': ['Part 2 - 2C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'PRAHS', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Venatorx Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}