Ignite Creation Date:
2025-12-24 @ 4:08 PM
Ignite Modification Date:
2026-02-24 @ 12:14 AM
Study NCT ID:
NCT02901366
Status:
COMPLETED
Last Update Posted:
2018-08-21
First Post:
2016-09-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mass Balance Study of FYU-981
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2018-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-20', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-12', 'lastUpdatePostDateStruct': {'date': '2018-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (Cmax: Maximum plasma concentration)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (AUC: Area under the plasma concentration-time curve)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (Tmax: Time to reach the peak plasma concentration)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (T1/2: Elimination half-life of plasma concentration)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (kel: Elimination rate constant)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (Vd/F: Distribution volume / Fraction of dose absorbed', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (CLtot/F: Total clearance / Fraction of dose absorbed)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (MRT: Mean residence time)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (Ae(urine), Ae(feces) and Ae(air): Amount of radioactivity excreted in urine, feces, or air)', 'timeFrame': '168 hours or 72 hours (Ae(air))'}, {'measure': 'Pharmacokinetics (fe(urine) , fe(feces) and fe(air): Fraction of radioactivity excreted in urine, feces, or air)', 'timeFrame': '168 hours or 72 hours (Ae(air))'}, {'measure': 'Pharmacokinetics (Ae(total): Total amount of radioactivity excreted)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (fe(total): Total fraction of radioactivity excreted)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (Ae(urine + air): Amount of radioactivity excreted in urine and air)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (fe(urine + air): Fraction of radioactivity excreted in urine and air)', 'timeFrame': '168 hours'}, {'measure': 'Pharmacokinetics (Ratios of FYU-981 and its metabolites in plasma, urine and feces)', 'timeFrame': '168 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mass balance'], 'conditions': ['Healthy Male Subjects']}, 'descriptionModule': {'briefSummary': 'To assess the plasma pharmacokinetics, the routes extent of elimination, and the metabolites of FYU-981 after a single 1 mg oral dose of 14C-FYU-981 in healthy male subjects.'}, '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\n* Have participated in a \\[14C\\]-study within the last 12 months prior to dosing of the investigational drug\n* Exposure to radiation for therapeutic or diagnostic reasons (except dental X-rays and plain X-rays of thorax and bony skeleton) within the last 12 months prior to dosing of the investigational drug\n* Occupationally exposed worker'}, 'identificationModule': {'nctId': 'NCT02901366', 'briefTitle': 'Mass Balance Study of FYU-981', 'organization': {'class': 'INDUSTRY', 'fullName': 'Fuji Yakuhin Co., Ltd.'}, 'officialTitle': 'Plasma Concentration, Excretion and Mass Balance Orally Administered 14C-FYU-981 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'FYU-981-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '14C-FYU-981', 'description': '14C-FYU-981, (Oral single dosing)', 'interventionNames': ['Drug: 14C-FYU-981']}], 'interventions': [{'name': '14C-FYU-981', 'type': 'DRUG', 'description': '14C-FYU-981, (Oral single dosing)', 'armGroupLabels': ['14C-FYU-981']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tokyo', 'country': 'Japan', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fuji Yakuhin Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Mochida Pharmaceutical Company, Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}