Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-07 @ 10:39 PM
Study NCT ID:
NCT05527834
Status:
COMPLETED
Last Update Posted:
2025-12-08
First Post:
2022-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077722', 'term': 'Ceftibuten'}], 'ancestors': [{'id': 'D002511', 'term': 'Cephalosporins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013843', 'term': 'Thiazines'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2023-02-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2022-09-01', 'studyFirstSubmitQcDate': '2022-09-01', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax', 'timeFrame': '0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects', 'description': 'Maximum observed plasma concentration (Cmax)'}, {'measure': 'AUC0-t', 'timeFrame': '0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects', 'description': 'Area under the plasma concentration-time curve (AUC) from time 0 up to the last quantifiable concentration at time t (AUC0-t)'}, {'measure': 'AUC0-inf', 'timeFrame': '0 hr (predose) through 48 hours for fasting subjects and 0 hr (predose) through 72 hours for fed subjects', 'description': 'AUC from time 0 extrapolated to infinity (AUC0-inf)'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is an open label, two period (fasted and fed), crossover study in up to 3 cohorts of 12 healthy adult participants per cohort (up to 36 participants in total). The pharmacokinetics (PK) of the inactive prodrug VNRX-7145, its active parent drug VNRX-5236, and ceftibuten will be evaluated after a single oral dose of ceftibuten/VNRX-7145.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adults 18-65 years\n* Males or non-pregnant, non-lactating females\n* Body mass index (BMI): ≥18.5 kg/m2 and ≤32.0 kg/m2\n* Laboratory values meeting defined entry criteria\n\nExclusion Criteria:\n\n* History of drug allergy or hypersensitivity to penicillin, cephalosporin, or β-lactam antibacterial drug\n* Conditions that potentially alter absorption and/or excretion of orally administered drugs\n* Congenital or acquired immunodeficiency syndrome\n* Positive alcohol, drug, or tobacco use/test'}, 'identificationModule': {'nctId': 'NCT05527834', 'briefTitle': 'Food Effect on Ceftibuten/VNRX-7145 in Healthy Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'Basilea Pharmaceutica'}, 'officialTitle': 'VNRX-7145-104: an Open-label, Cross-over Study to Evaluate the Effect of Food on the Pharmacokinetics, Safety, and Tolerability of Ceftibuten/VNRX-7145 in Healthy Participants.', 'orgStudyIdInfo': {'id': 'VNRX-7145-104'}, 'secondaryIdInfos': [{'id': '272201600029C-P00017-9999-1', 'link': 'https://reporter.nih.gov/quickSearch/272201600029C-P00017-9999-1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': 'Cohort 1 will assess the impact of a high fat meal.', 'interventionNames': ['Drug: VNRX-7145', 'Drug: Ceftibuten']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': 'Cohort 2 will be conducted to assess the impact of an alternative lower fat meal if administration with high fat meal has a food effect on drug exposure.', 'interventionNames': ['Drug: VNRX-7145', 'Drug: Ceftibuten']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': 'Cohort 3 will evaluate realistic fasting intervals and/or additional meal types if administration with food has a food effect on drug exposure.', 'interventionNames': ['Drug: VNRX-7145', 'Drug: Ceftibuten']}], 'interventions': [{'name': 'VNRX-7145', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}, {'name': 'Ceftibuten', 'type': 'DRUG', 'description': 'Single oral dose', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66219', 'city': 'Lenexa', 'state': 'Kansas', 'country': 'United States', 'facility': 'ICON Plc.', 'geoPoint': {'lat': 38.95362, 'lon': -94.73357}}], 'overallOfficials': [{'name': 'Kamal Hamed, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Basilea Pharmaceutica International Ltd, Allschwil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Basilea Pharmaceutica', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'National Institute of Allergy and Infectious Diseases (NIAID)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}