Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 2:37 AM
Study NCT ID:
NCT07314320
Status:
COMPLETED
Last Update Posted:
2026-01-02
First Post:
2025-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Detect Radioactivity of [14C]-OPC-167832 in Urine and Feces in Healthy Men
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, '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': '2023-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-18', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)', 'timeFrame': 'Up to Day 31'}, {'measure': 'Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)', 'timeFrame': 'Up to Day 31'}, {'measure': 'Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)', 'timeFrame': 'Up to Day 31'}, {'measure': 'Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)', 'timeFrame': 'Up to Day 31'}], 'secondaryOutcomes': [{'measure': 'Maximum (peak) Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood', 'timeFrame': 'Up to Day 31'}, {'measure': 'Time to Maximum (Peak) Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood', 'timeFrame': 'Up to Day 31'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Observable Concentration (AUCt) of Total Radioactivity in Plasma and Whole Blood', 'timeFrame': 'Up to Day 31'}, {'measure': 'Area Under the Concentration-Time Curve From Time Zero to infinity (AUCinfinity) of Total Radioactivity in Plasma and Whole Blood', 'timeFrame': 'Up to Day 31'}, {'measure': 'Terminal-phase Elimination Half-life (t1/2,z) of Total Radioactivity in Plasma and Whole Blood', 'timeFrame': 'Up to Day 31'}, {'measure': 'Hemocrit Blood to Plasma Concentration Adjusted Ratio', 'timeFrame': 'Up to Day 31'}, {'measure': 'Percentage of Metabolite in Plasma With an AUC > 10% of the AUC of Plasma Radioactivity Based on Radiometric Profiling', 'timeFrame': 'Up to Day 31'}, {'measure': 'Cmax of OPC-167832', 'timeFrame': 'Up to Day 31'}, {'measure': 'Tmax of OPC-167832', 'timeFrame': 'Up to Day 31'}, {'measure': 'AUCt of OPC-167832', 'timeFrame': 'Up to Day 31'}, {'measure': 'AUCinfinity of OPC-167832', 'timeFrame': 'Up to Day 31'}, {'measure': 't1/2,z of OPC-167832', 'timeFrame': 'Up to Day 31'}, {'measure': 'Apparent Clearance (CL/F) of Drug from Plasma Following Extravascular Administration of OPC-167832', 'timeFrame': 'Up to Day 31'}, {'measure': 'Percent Radioactivity Excreted in Urine and Feces as Parent and Identified Metabolites From Profiling data', 'timeFrame': 'Up to Day 31'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAEs)', 'timeFrame': 'Up to Day 31'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests', 'timeFrame': 'Up to Day 31'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Changes in Vital Signs', 'timeFrame': 'Up to Day 31'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Changes in Physical Examinations', 'timeFrame': 'Up to Day 31'}, {'measure': 'Number of Participants With Potentially Clinically Relevant Changes in Electrocardiogram (ECG) Parameters', 'timeFrame': 'Up to Day 31'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the relative amounts of radioactivity excreted in urine and feces following a single oral dose of \\[14C\\]-OPC-167832 in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m\\^2) (inclusive).\n2. In good health as determined by:\n\n 1. Medical history\n 2. Physical examination\n 3. ECG\n 4. Serum/urine biochemistry, hematology, and serology tests.\n3. Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.\n4. Agree to remain exclusively in the research unit for the defined period.\n5. Agree to comply with the protocol restrictions and requirements.\n6. Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.\n7. Male participants and their female partners who commit to remaining abstinent from trial screening through 90 days after the dose of investigational medicinal product (IMP) or utilizing 2 different approved methods of birth control from trial screening through 90 days after the dose of IMP.\n8. Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP.\n\nExclusion Criteria:\n\n1. Clinically relevant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including distribution, metabolism, and excretion of drug.\n2. History of drug and/or alcohol abuse within 2 years prior to screening.\n3. History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.\n4. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.\n5. Participants having taken OPC-167832 within 30 days prior to screening.\n6. Participants having 5 half-lives or twice the duration of the biological effect, whichever is longer, of any IMP (inclusive of OPC-167832) within 30 days prior to screening.\n7. Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.\n8. Any participant who, in the opinion of the investigator, should not participate in the trial.\n\nNote: Other protocol-specified inclusion/exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT07314320', 'briefTitle': 'A Study to Detect Radioactivity of [14C]-OPC-167832 in Urine and Feces in Healthy Men', 'organization': {'class': 'INDUSTRY', 'fullName': 'Otsuka Pharmaceutical Development & Commercialization, Inc.'}, 'officialTitle': 'A Phase 1, Open-Label, Single-Dose Trial to Evaluate the Mass Balance and Pharmacokinetics of [14C]-OPC-167832 Administered Orally in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '323-201-00002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]-OPC-167832', 'description': 'Participants receive a single dose of \\[14C\\]-OPC-167832, orally, on Day 1.', 'interventionNames': ['Drug: [14C]-OPC-167832']}], 'interventions': [{'name': '[14C]-OPC-167832', 'type': 'DRUG', 'description': 'Oral suspension', 'armGroupLabels': ['[14C]-OPC-167832']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion, Inc', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'ipdSharingStatementModule': {'url': 'https://clinical-trials.otsuka.com/', 'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.', 'ipdSharing': 'YES', 'description': 'Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.', 'accessCriteria': 'Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Otsuka Pharmaceutical Development & Commercialization, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}