Ignite Creation Date:
2025-12-25 @ 12:04 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT04182958
Status:
COMPLETED
Last Update Posted:
2021-10-06
First Post:
2019-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'CL_OPCJ_RDA_Team@otsuka.jp', 'phone': '+81-3-6361-7366', 'title': 'Director of Clinical Trials', 'organization': 'Otsuka Pharmaceutical Co., LTD.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Treatment-emergent adverse events (TEAEs) were collected from the start of investigational medicinal product (IMP) administration up to 12 days', 'description': 'The safety population included all subjects that received (14C)-OPC-61815.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 1, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver. 22.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '2060', 'spread': '305', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1500', 'spread': '156', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.61', 'spread': '1.34', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'AUC∞ - Plasma OPC-41061', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '1150', 'spread': '230', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after dose', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Cmax - Plasma OPC-41061', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '204', 'spread': '27.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 't1/2,z - Plasma OPC-41061', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.27', 'spread': '0.826', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours after dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'AUC∞ - Plasma Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '30300', 'spread': '4850', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hours after dose', 'unitOfMeasure': 'h*ngEq/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 'Cmax - Plasma Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '2180', 'spread': '188', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hours after dose', 'unitOfMeasure': 'ngEq/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}, {'type': 'PRIMARY', 'title': 't1/2,z - Plasma Total Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'spread': '33.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '168 hours after dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population included all subjects that received (14C)-OPC-61815 (full dose within the time frame of 55 to 65 minutes, inclusive) and had evaluable PK data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Overall: (14C)-OPC-61815', 'description': 'Subjects were to receive a single IV infusion of 16 mg (14C)-OPC-61815, containing approximately 75.1 μCi (2.78 MBq), over a period of 60 minutes (55 to 65 minutes, inclusive) on Day 1 of the trial.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43', 'spread': '5.8', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Japanese', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-11-14', 'size': 957161, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-09-08T02:07', 'hasProtocol': True}, {'date': '2019-12-11', 'size': 334940, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-09-08T02:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-08', 'studyFirstSubmitDate': '2019-11-27', 'resultsFirstSubmitDate': '2021-09-08', 'studyFirstSubmitQcDate': '2019-11-27', 'lastUpdatePostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-08', 'studyFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2021-10-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Concentration-time Curve From Time Zero to Infinity (AUC∞) - Plasma OPC-61815 Free Form', 'timeFrame': '48 hours after dose'}, {'measure': 'Maximum Peak Concentration (Cmax) - Plasma OPC-61815 Free Form', 'timeFrame': '48 hours after dose'}, {'measure': 'Terminal-phase Elimination Half-life (t1/2,z) - Plasma OPC-61815 Free Form', 'timeFrame': '48 hours after dose'}, {'measure': 'AUC∞ - Plasma OPC-41061', 'timeFrame': '48 hours after dose'}, {'measure': 'Cmax - Plasma OPC-41061', 'timeFrame': '48 hours after dose'}, {'measure': 't1/2,z - Plasma OPC-41061', 'timeFrame': '48 hours after dose'}, {'measure': 'AUC∞ - Plasma Total Radioactivity', 'timeFrame': '168 hours after dose'}, {'measure': 'Cmax - Plasma Total Radioactivity', 'timeFrame': '168 hours after dose'}, {'measure': 't1/2,z - Plasma Total Radioactivity', 'timeFrame': '168 hours after dose'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Adult Male']}, 'descriptionModule': {'briefSummary': '* To determine the mass balance of totalradioactivity following a single IV infusionof (14C)-OPC-61815.\n* To determine routes and rates of elimination of total radioactivity following a single IV infusion of (14C)-OPC-61815\n* To assess the PK of total radioactivity in plasma and whole blood following a single IV infusion of (14C)-OPC-61815\n* To assess the PK of OPC-61815 free form and OPC-41061 in plasma following a single IV infusion of (14C)-OPC-61815'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male subjects between 35 and 55 years of age, inclusive; hold a valid Japanese passport and be first generation Japanese, defined as the subject, the subject's biological parent, and all of the subject's biological grandparents being of exclusive Japanese descent, have been born in Japan, and not lived outside of Japan for more than 5 years; with a body mass index between 18.5 and 28.0 kg/m2, inclusive, and a total body weight between 50 and 100 kg, inclusive; in good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), vital sign measurements, and clinical laboratory evaluations at Screening and Check in as assessed by the investigator (or designee); and have a history of a minimum of 1 bowel movement per day.\n\nExclusion Criteria:\n\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion; poor peripheral venous access; participation in a clinical trial involving administration of an investigational drug in the past 90 days prior to dosing; subjects with exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to Check-in; subjects who have participated in any clinical trial involving a radiolabeled investigational drug within 12 months prior to Check-in."}, 'identificationModule': {'nctId': 'NCT04182958', 'briefTitle': 'A Phase I, Open-Label Trial to Assess the Absorption, Metabolism, and Excretion of (14C)-OPC-61815 in Healthy Male Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase I, Open-Label Trial to Assess the Mass Balance and Pharmacokinetics of a Single Intravenous Administration of (14C)-OPC-61815 to Healthy Male Japanese Subjects', 'orgStudyIdInfo': {'id': '263-102-00006'}, 'secondaryIdInfos': [{'id': '2019-001968-29', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(14C)-OPC-61815', 'interventionNames': ['Drug: (14C)-OPC-61815']}], 'interventions': [{'name': '(14C)-OPC-61815', 'type': 'DRUG', 'description': 'On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815', 'armGroupLabels': ['(14C)-OPC-61815']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS2 9LH', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Covance Clinical Research Unit Ltd', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Takehisa Matsumaru, Mr', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Otsuka Pharmaceutical Co., Ltd.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Small studies with less than 25 participants are excluded from data sharing.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}