Ignite Creation Date:
2025-12-25 @ 3:02 AM
Ignite Modification Date:
2026-02-23 @ 8:56 PM
Study NCT ID:
NCT02440633
Status:
COMPLETED
Last Update Posted:
2016-10-21
First Post:
2015-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '+81-3-6361-7366', 'title': 'Study Director, Yoshitaka Kotobuki, Mr', 'organization': 'Otsuka Pharmaceutical Co., Ltd.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From informed Consent up to 22 days post dose', 'eventGroups': [{'id': 'EG000', 'title': '14C-OPS-2071', 'description': 'Suspension containing 50 mg of 14C-OPS-2071\n\n14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.', 'otherNumAtRisk': 8, 'otherNumAffected': 4, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}, {'term': 'Alanine aminotransferase increase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Ver18.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Amounts of Radioactivity Excreted in Urine and Faeces', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Feces'}, {'id': 'OG001', 'title': 'Urine'}, {'id': 'OG002', 'title': 'Total'}], 'classes': [{'categories': [{'measurements': [{'value': '78.0', 'spread': '13.1', 'groupId': 'OG000'}, {'value': '6.08', 'spread': '1.71', 'groupId': 'OG001'}, {'value': '84.1', 'spread': '12.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to144-168h postdose.', 'description': 'A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.', 'unitOfMeasure': 'percentage of administered dose', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Plasma'}, {'id': 'OG001', 'title': 'Whole Blood'}], 'classes': [{'categories': [{'measurements': [{'value': '649.0', 'spread': '486.0', 'groupId': 'OG000'}, {'value': '411.0', 'spread': '73.9', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.', 'description': 'A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.', 'unitOfMeasure': 'μg eq.·h/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'AUC of OPS-2071 in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Plasma'}], 'classes': [{'categories': [{'measurements': [{'value': '392.0', 'spread': '95.8', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.', 'description': 'A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.', 'unitOfMeasure': 'μg·h/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '14C-OPS-2071', 'description': 'Suspension containing 50 mg of 14C-OPS-2071\n\n14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.'}], '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': '14C-OPS-2071', 'description': 'Suspension containing 50 mg of 14C-OPS-2071\n\n14C-OPS-2071: Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42.0', 'spread': '4.8', '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': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, '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': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'completionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-08-30', 'studyFirstSubmitDate': '2015-05-01', 'resultsFirstSubmitDate': '2016-07-10', 'studyFirstSubmitQcDate': '2015-05-07', 'lastUpdatePostDateStruct': {'date': '2016-10-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-07-10', 'studyFirstPostDateStruct': {'date': '2015-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Amounts of Radioactivity Excreted in Urine and Faeces', 'timeFrame': 'up to144-168h postdose.', 'description': 'A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We evaluated the cumulative excretion of total radioactivity (%) in feces and urine, up to 168 hours postdose.'}, {'measure': 'Area Under Curve (AUC) of Total Radioactivity in Plasma and Whole Blood', 'timeFrame': 'predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.', 'description': 'A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured total radioactivity in plasma and whole blood each. We evaluated AUC 0-168h of total radioactivity in plasma and whole blood each. The AUCs in plasma and whole blood are of total radioactivity including the parent and metabolites.'}, {'measure': 'AUC of OPS-2071 in Plasma', 'timeFrame': 'predose, 0.5, 1, 2, 3, 4, 6, 8, 12, 24, 48, 72, 96, 120, 144, and 168 h postdose.', 'description': 'A single dose of 14C-OPS-2071was administered as an oral suspension under fasting conditions on the morning of Day 1. We measured OPS-2071 concentration in plasma and evaluated AUC 0-168h of OPS-2071 in plasma.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Bacterial Enteritis']}, 'descriptionModule': {'briefSummary': 'To obtain absorption, metabolism and excretion data for parent drug and any metabolites.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* Body mass index (BMI) between 18.5 and 25.0 kg/m2, inclusive\n* Subjects will have given their written informed consent to participate in the study and to abide by the study restrictions\n\nExclusion Criteria:\n\n* Subjects who have a significant history of alcoholism or drug/chemical abuse, as determined by the Investigator.\n* Subjects who smoke, or who have used nicotine within 3 months prior to screening..\n* Subjects who have a significant history of drug allergy, as determined by the Investigator.\n* Subjects who have any clinically significant abnormal physical examination finding.\n* Subjects who have any clinically significant medical history, as determined by the Investigator.\n* Subjects who are exposed to radiation as a result of their occupation.\n* Subjects who have had an X ray or CT scan, or who have participated in any trial involving a radiolabelled investigational product or have been exposed to radiolabelled substances within 12 months prior to dose administration.'}, 'identificationModule': {'nctId': 'NCT02440633', 'briefTitle': 'A Phase 1,Open -Label Study to Assess the Absorption, Metabolism and Excretion of 14C-OPS-2071 Following a Single Oral Dose to Healthy Male Japanese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Co., Ltd.'}, 'orgStudyIdInfo': {'id': '341-14-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '14C-OPS-2071', 'description': 'Suspension containing 50 mg of 14C-OPS-2071', 'interventionNames': ['Drug: 14C-OPS-2071']}], 'interventions': [{'name': '14C-OPS-2071', 'type': 'DRUG', 'description': 'Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.', 'armGroupLabels': ['14C-OPS-2071']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leeds', 'country': 'United Kingdom', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}], 'overallOfficials': [{'name': 'Yoshitaka Kotobuki', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Small Global, Division of New Product Evaluation and Development'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}