Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2026-01-06 @ 5:05 AM
Study NCT ID:
NCT03878693
Status:
COMPLETED
Last Update Posted:
2019-09-26
First Post:
2019-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
4-methylpyrazole and Acetaminophen Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077604', 'term': 'Fomepizole'}, {'id': 'D000082', 'term': 'Acetaminophen'}], 'ancestors': [{'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2019-03-14', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oxidative metabolism of APAP', 'timeFrame': '24 hours', 'description': 'Measurement of oxidized metabolites of APAP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Volunteers']}, 'referencesModule': {'references': [{'pmid': '31768936', 'type': 'DERIVED', 'citation': 'Kang AM, Padilla-Jones A, Fisher ES, Akakpo JY, Jaeschke H, Rumack BH, Gerkin RD, Curry SC. The Effect of 4-Methylpyrazole on Oxidative Metabolism of Acetaminophen in Human Volunteers. J Med Toxicol. 2020 Apr;16(2):169-176. doi: 10.1007/s13181-019-00740-z. Epub 2019 Nov 25.'}]}, 'descriptionModule': {'briefSummary': 'Oxidative metabolism of APAP will be studied with and without 4-MP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy\n* No APAP use in previous 2 weeks\n* No ingestion of alcohol or drugs that affect CYP 2E1 over previous 5 days\n* No allergy to APAP or fomepizole\n* BMI \\< 29\n\nExclusion Criteria:\n\n* Pregnant or lactating\n* History of alcohol abuse\n* Allergy to APAP or fomepizole\n* Screening LFTs above normal range'}, 'identificationModule': {'nctId': 'NCT03878693', 'briefTitle': '4-methylpyrazole and Acetaminophen Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': 'The Effect of 4-methylpyrazole on Oxidative Metabolism of Acetaminophen in Healthy Volunteers', 'orgStudyIdInfo': {'id': '1805526976'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'Oral APAP and IV Fomepizole.', 'interventionNames': ['Drug: Fomepizole', 'Drug: APAP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'Oral APAP.', 'interventionNames': ['Drug: APAP']}], 'interventions': [{'name': 'Fomepizole', 'type': 'DRUG', 'description': 'IV 4-MP.', 'armGroupLabels': ['A']}, {'name': 'APAP', 'type': 'DRUG', 'description': 'Oral APAP', 'armGroupLabels': ['A', 'B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'BUMCP - Department of Medical Toxicology', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}