Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-02-26 @ 1:57 AM
Study NCT ID:
NCT03306667
Status:
COMPLETED
Last Update Posted:
2018-09-24
First Post:
2017-09-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706811', 'term': 'dotinurad'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-21', 'studyFirstSubmitDate': '2017-09-20', 'studyFirstSubmitQcDate': '2017-10-05', 'lastUpdatePostDateStruct': {'date': '2018-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (Cmax: Maximum plasma concentration)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (AUC: Area under the plasma concentration-time curve)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (kel: Elimination rate constant)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacokinetics (MRT: Mean residence time)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacodynamics (Serum concentration of uric acid)', 'timeFrame': '48 hours'}, {'measure': 'Pharmacodynamics (Amount of uric acid excreted in urine)', 'timeFrame': '48 hours'}, {'measure': 'Safety (Incidence of treatment-emergent adverse events)', 'timeFrame': '192 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatic Insufficiency', 'Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety after single oral administration of FYU-981 to subjects with hepatic insufficiency and with normal hepatic function.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult healthy subjects or adult cirrhosis patients\n* Body mass index: \\>=18.5 and \\<30.0\n\nExclusion Criteria:\n\n* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study (except for cirrhosis patients with hepatic diseases)'}, 'identificationModule': {'nctId': 'NCT03306667', 'briefTitle': 'Clinical Pharmacology of FYU-981 (Subjects With Hepatic Insufficiency)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mochida Pharmaceutical Company, Ltd.'}, 'officialTitle': 'Clinical Pharmacology Study of FYU-981 for Subjects With Hepatic Insufficiency', 'orgStudyIdInfo': {'id': 'FYU-981-015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Normal group', 'description': 'Healthy control subjects', 'interventionNames': ['Drug: FYU-981']}, {'type': 'EXPERIMENTAL', 'label': 'Mild hepatic-insufficient group', 'description': 'Patients with mild hepatic impaired function (Child-Pugh A)', 'interventionNames': ['Drug: FYU-981']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate hepatic-insufficient group', 'description': 'Patients with moderate hepatic impaired function (Child-Pugh B)', 'interventionNames': ['Drug: FYU-981']}, {'type': 'EXPERIMENTAL', 'label': 'Severe hepatic-insufficient group', 'description': 'Patients with severe hepatic impaired function (Child-Pugh C)', 'interventionNames': ['Drug: FYU-981']}], 'interventions': [{'name': 'FYU-981', 'type': 'DRUG', 'description': 'Oral single dosing', 'armGroupLabels': ['Mild hepatic-insufficient group', 'Moderate hepatic-insufficient group', 'Normal group', 'Severe hepatic-insufficient group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Mochida Investigational sites', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Shigeki Matsumoto', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Clinical Research Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mochida Pharmaceutical Company, Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Fuji Yakuhin Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}