Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-03-04 @ 10:20 PM
Study NCT ID:
NCT02348333
Status:
COMPLETED
Last Update Posted:
2015-01-28
First Post:
2015-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Repeated Dose Phase I Study of FYU-981
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000706811', 'term': 'dotinurad'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-22', 'studyFirstSubmitDate': '2015-01-18', 'studyFirstSubmitQcDate': '2015-01-22', 'lastUpdatePostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (Cmax: Maximum plasma concentration)', 'timeFrame': '1-, 4-, and 7-day'}, {'measure': 'Pharmacokinetics (Cmin: Minimum plasma concentration)', 'timeFrame': '1-, 2-, 3-, 4-, 5-, 6- and 7-day'}, {'measure': 'Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)', 'timeFrame': '1-, 4-, and 7-day'}, {'measure': 'Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)', 'timeFrame': '1-, 4-, and 7-day'}, {'measure': 'Pharmacokinetics (AUC: Area under the plasma concentration-time curve)', 'timeFrame': '1-, 4-, and 7-day'}, {'measure': 'Pharmacokinetics (Rauc: Accumulation ratio of AUC0-24)', 'timeFrame': '4-, and 7-day'}, {'measure': 'Pharmacokinetics (kel: Elimination rate constant)', 'timeFrame': '1-, 4-, and 7-day'}, {'measure': 'Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)', 'timeFrame': '1-, 4-, and 7-day'}, {'measure': 'Pharmacokinetics (Ae: Amount of drug excreted in urine)', 'timeFrame': '9 days'}, {'measure': 'Pharmacokinetics (fe: Fraction of dose excreted in urine)', 'timeFrame': '9 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 7-day-repeated doses of FYU-981 administered orally to healthy male adults once daily. Participants are randomized to placebo (n=3) or FYU-981 (n=6) in each step. After follow-up examination in the step of lower dose, the next dose is administered.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese healthy adult subjects\n* Body mass index: \\>=18.5 and \\<25.0\n\nExclusion Criteria:\n\n* Subjects with any disease or any history of diseases that might be unsuitable for participation in the clinical study'}, 'identificationModule': {'nctId': 'NCT02348333', 'briefTitle': 'Repeated Dose Phase I Study of FYU-981', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fuji Yakuhin Co., Ltd.'}, 'officialTitle': 'Seven-day Repeated Dose Clinical Pharmacological Study of FYU-981 Administered to Healthy Male Adults (Phase I Study).', 'orgStudyIdInfo': {'id': 'FYU-981-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'FYU-981', 'interventionNames': ['Drug: FYU-981, (Oral daily dosing for 7 days)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo, (Oral daily dosing for 7 days)']}], 'interventions': [{'name': 'FYU-981, (Oral daily dosing for 7 days)', 'type': 'DRUG', 'description': 'Subjects randomized to the FYU-981 arm receive active drug, FYU-981.', 'armGroupLabels': ['FYU-981']}, {'name': 'Placebo, (Oral daily dosing for 7 days)', 'type': 'DRUG', 'description': 'Subjects randomized to the placebo arm receive placebo.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'facility': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuji Yakuhin Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}