Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-13 @ 5:32 PM
Study NCT ID:
NCT05320861
Status:
COMPLETED
Last Update Posted:
2022-04-11
First Post:
2022-03-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-01', 'studyFirstSubmitDate': '2022-03-23', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]SJP-0008', 'timeFrame': 'Until the mass balance criteria for all participants have been met (estimated up to Day 10)', 'description': 'Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in plasma, urine and faeces samples.'}], 'secondaryOutcomes': [{'measure': 'Maximum plasma concentration (Cmax) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'Area under the concentration-time curve from time zero to last measurable concentration (AUC0-last) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'Area under concentration-time curve from time zero to infinity (AUC0-inf) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'Area under the concentration-time curve from time of the last measurable concentration to infinity as a percentage of the area under the curve extrapolated to infinity (AUCextrap) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'Time to maximum plasma concentration (Tmax) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'Half-life (T1/2) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'First order rate constant associated with the terminal (log-linear) portion of the curve (Lambda-z) of SJP-0008 and SNJ-2026', 'timeFrame': 'Up to Day 8'}, {'measure': 'Percentage of participants with adverse events (AEs)', 'timeFrame': 'Until the mass balance criteria for all participants have been met (estimated up to Day 10)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mass Balance Recovery', 'Metabolite Profile', 'Metabolite Identification'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'This single centre, open-label, non-randomised, single period, single-dose study in healthy male subjects was designed and conducted to assess the mass balance recovery, PK, metabolite profile and metabolite identification of SJP-0008.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index (BMI) of 18.0 to 32.0 kg/m2 as measured at screening\n* Must be willing and able to communicate and participate in the whole study\n* Must have regular bowel movements\n* Must provide written informed consent\n* Must agree to adhere to the contraception requirements of the protocol\n\nExclusion Criteria:\n\n* Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1\n* Subjects who are, or are immediate family members of, a study site or sponsor employee\n* Subjects who report to have previously received SJP-0008\n* Evidence of current SARS-CoV-2 infection\n* History of any drug or alcohol abuse in the past 2 years\n* Regular alcohol consumption in males \\>21 units per week\n* A confirmed positive alcohol breath test at screening or admission\n* Current smokers and those who have smoked within the last 6 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission\n* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 6 months\n* Subjects with pregnant or lactating partners\n* Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study\n\nOther protocol-defined exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT05320861', 'briefTitle': 'Single Dose ADME Study of [14C]SJP-0008 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Senju Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Single Dose Study Designed to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]SJP-0008 in Healthy Male Subjects After an Oral Dose', 'orgStudyIdInfo': {'id': 'SJP-0008/1-02'}, 'secondaryIdInfos': [{'id': '2021-002615-65', 'type': 'EUDRACT_NUMBER'}, {'id': '18pc0101026h0001', 'type': 'OTHER_GRANT', 'domain': 'The Japan Agency for Medical Research and Development'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]SJP-0008', 'interventionNames': ['Drug: [14C]SJP-0008']}], 'interventions': [{'name': '[14C]SJP-0008', 'type': 'DRUG', 'description': 'Single oral dose of \\[14C\\]SJP-0008', 'armGroupLabels': ['[14C]SJP-0008']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NG11 6JS', 'city': 'Ruddington', 'state': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.89254, 'lon': -1.14953}}], 'overallOfficials': [{'name': 'Somasekhara Menakuru', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Senju Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Quotient Sciences', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}