Ignite Creation Date:
2025-12-24 @ 6:39 PM
Ignite Modification Date:
2025-12-27 @ 9:46 PM
Study NCT ID:
NCT01419457
Status:
COMPLETED
Last Update Posted:
2015-10-22
First Post:
2011-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C462182', 'term': 'favipiravir'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2011-08-10', 'studyFirstSubmitQcDate': '2011-08-17', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of favipiravir', 'timeFrame': 'predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5', 'description': 'The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.'}, {'measure': 'AUC of favipiravir', 'timeFrame': 'predose and 0.25, 0.5, 0.75, 1, 2, 4, 6, 12, 18, 24, 36, 48 hours post-dose on Day 1 and Day 5', 'description': 'The PK parameters for favipiravir and its metabolite in hepatically impaired adult subjects relative to healthy adult subjects matched for age, weight, gender, and race status on Day 1 and on Day 5.'}], 'secondaryOutcomes': [{'measure': 'vital signs', 'timeFrame': '13 days'}, {'measure': 'electrocardiograms [ECGs]', 'timeFrame': '13 days'}, {'measure': 'clinical laboratory assessment', 'timeFrame': '13 days'}, {'measure': 'adverse events [AEs]', 'timeFrame': '13 days'}, {'measure': 'physical examination', 'timeFrame': '13 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Healthy', 'hepatic impairment', 'T-705a', 'Favipiravir'], 'conditions': ['Healthy', 'Hepatic Impairment']}, 'descriptionModule': {'briefSummary': 'This study is designed to determine the pharmacokinetics of favipiravir in volunteers with hepatic impairment and in healthy control volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hepatically impaired groups:\n\n * Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.\n * Have mild hepatic impairment (Child-Pugh Clinical Assessment Score Grade A, score 5 6) or moderate hepatic impairment (Child-Pugh Clinical Assessment Score Grade B, score 7-9) or severe hepatic impairment (Child-Pugh Clinical Assessment Score Grade C, score 10-15);\n* Control group\n\n * Agree to doctor approved birth control methods from Day 1 until 3 months following the final dose of study drug.\n * Healthy as determined by medical history, physical exam, vital signs, ECGs, and clinical laboratory tests.\n\nExclusion Criteria:\n\n* Hepatically impaired groups:\n\n * Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;\n * Have any acute or unstable condition or disease, other than impaired hepatic function, as determined by medical history, physical exam, ECG and clinical laboratory tests;\n * Known ongoing alcohol and/or drug abuse within 1 month\n * Any evidence of progressive worsening liver function disease as indicated by laboratory values;\n * Have had an acute flare of hepatitis A or B within 6 months;\n * Have acute, fulminant alcoholic hepatitis, determined either clinically or by histology;\n * Have a history of hepatoma or metastatic disease of the liver;\n* Control group:\n\n * Have used any drugs known to significantly affect hepatic metabolism within 28 days, or is unable or unwilling to forgo the use of such products throughout the study;\n * Have a history or presence of clinically cardiovascular, dermatologic, endocrine, gastrointestinal, hematologic, hepatic, immunologic, neurologic, oncologic, psychiatric, pulmonary, or renal disease or any other condition.'}, 'identificationModule': {'nctId': 'NCT01419457', 'briefTitle': 'Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'MDVI, LLC'}, 'officialTitle': 'A Phase I, Open-Label, Parallel-Group, Multiple-Dose Study to Determine the Pharmacokinetics of Favipiravir in Volunteers With Hepatic Impairment and in Healthy Control Volunteers', 'orgStudyIdInfo': {'id': 'T705aUS109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Normal hepatic function', 'interventionNames': ['Drug: Favipiravir']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Mild hepatic impairment', 'interventionNames': ['Drug: Favipiravir']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Moderate hepatic impairment', 'interventionNames': ['Drug: Favipiravir']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Severe hepatic impairment', 'interventionNames': ['Drug: Favipiravir']}], 'interventions': [{'name': 'Favipiravir', 'type': 'DRUG', 'otherNames': ['T-705a'], 'description': '1200 mg BID for Day 1 + 800 mg BID for Day 2-5', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3']}, {'name': 'Favipiravir', 'type': 'DRUG', 'otherNames': ['T-705a'], 'description': '800 mg BID for Day 1 + 400 mg BID for Day 2-3', 'armGroupLabels': ['Group 1', 'Group 4']}, {'name': 'Favipiravir', 'type': 'DRUG', 'description': '800 mg Single Dose', 'armGroupLabels': ['Group 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Clinical Research Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Richard A. Preston, MD/MSHP/MBA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MDVI, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}