Ignite Creation Date:
2025-12-25 @ 2:53 AM
Ignite Modification Date:
2025-12-26 @ 1:34 AM
Study NCT ID:
NCT05737433
Status:
COMPLETED
Last Update Posted:
2024-10-03
First Post:
2023-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000654430', 'term': 'CRV-431'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jgreytok@hepionpharma.com', 'phone': '732-902-4000', 'title': 'Jill Greytok', 'organization': 'Hepion Pharmaceuticals Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '63 days, screening period to on study last visit.', 'eventGroups': [{'id': 'EG000', 'title': '[14C]-RCF 225mg', 'description': '\\[14C\\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 26.0'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '[14C]-RCF 225mg', 'description': '\\[14C\\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose'}], 'classes': [{'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '22 Days', 'description': 'Cumulative percentage of total radioactivity recovered after a single oral dose of \\[14C\\]-rencofilstat.', 'unitOfMeasure': 'percentage of total radioactivity', 'reportingStatus': 'POSTED', 'populationDescription': 'Mass balance population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '[14C]-RCF 225mg', 'description': '\\[14C\\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'After subjects consented for study, they went through the screening process. Subjects that qualified for study were assigned to the single treatment arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '[14C]-RCF 225mg', 'description': '\\[14C\\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose\n\n\\[14C\\]-rencofilstat 225mg: radio-labelled 225mg oral dose of rencofilstat'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': '% of [14C]-RCF recovered', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': '%'}], 'populationDescription': 'Baseline population contains 6 six subjects. The same subjects are in the pharmacokinetic population and safety population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-22', 'size': 746746, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-06-23T09:56', 'hasProtocol': True}, {'date': '2023-02-10', 'size': 903750, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2024-06-23T10:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open label, non-randomized, single period, and single dose'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2023-08-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-23', 'studyFirstSubmitDate': '2023-02-10', 'resultsFirstSubmitDate': '2024-06-23', 'studyFirstSubmitQcDate': '2023-02-10', 'lastUpdatePostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-06-23', 'studyFirstPostDateStruct': {'date': '2023-02-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Determine the Mass Balance Recovery After a Single Oral Dose of [14C]-Rencofilstat', 'timeFrame': '22 Days', 'description': 'Cumulative percentage of total radioactivity recovered after a single oral dose of \\[14C\\]-rencofilstat.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nonalcoholic Steatohepatitis', 'NASH', 'NAFLD'], 'conditions': ['NASH With Fibrosis']}, 'descriptionModule': {'briefSummary': 'This is a single-center, single-period, single-dose, open-label, non-randomized study to assess the mass balance recovery, metabolite profile and metabolite identification of 14C- labelled rencofilstat (\\[14C\\] CRV431). It is planned to enroll 6 healthy male subjects in a single group. Each subject will receive a single 225 mg oral dose of \\[14C\\] CRV431 self-micro emulsifying drug delivery system (SMEDDS) oral emulsion.', 'detailedDescription': 'This is a single center, open-label, non-randomized, single period, single dose study in healthy male subjects designed to assess the mass balance recovery, pharmacokinetics (PK), metabolite profile and metabolite identification of rencofilstat. It is planned to enroll a single cohort of 6 subjects. All subjects will receive a single 225 mg oral dose of \\[14C\\]-rencofilstat, as a SMEDDS oral emulsion in the fasted state.\n\nSubjects will undergo preliminary screening procedures for the study at the screening visit (Day -28 to Day -2). Subjects will be admitted in the evening on the day before dosing (Day-1).\n\nWhole blood, plasma, urine and feces samples will be collected at regular intervals for PK analysis, total radioactivity analysis, metabolite profiling, mass balance and safety as applicable, from pre-dose to discharge from the clinical unit. Urine and feces samples may be collected at return visits or home visits if mass balance criteria have not been met by a subject.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Healthy males\n2. Aged 30 to 65 years inclusive at the time of signing informed consent\n3. Body mass index (BMI) of 18.0 to 35.0 kg/m2 as measured at screening\n4. Must be willing and able to communicate and participate in the whole study\n5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)\n6. Must provide written informed consent\n7. Must agree to adhere to the contraception requirements\n\nExclusion Criteria:\n\n1. Subjects who have received any investigational treatment in a clinical research study within the 90 days prior to Day 1, or less than 5 elimination half-lives prior to Day 1, whichever is longer\n2. Subjects who are, or are immediate family members of, a study site or sponsor employee\n3. Evidence or history of current SARS-CoV-2 infection within 4 weeks prior to study drug administration\n4. History of any drug or alcohol abuse in the past 2 years prior to screening\n5. Regular alcohol consumption in males \\>21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)\n6. A confirmed positive alcohol breath test at screening or admission\n7. Current smokers and those who have smoked within the last 12 months prior to screening\n8. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission\n9. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months prior to screening\n10. 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\n11. Subjects who do not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator or delegate at screening\n12. Clinically significant abnormal clinical chemistry, haematology or urinalysis as judged by the investigator. Subjects known to have Gilbert's syndrome are excluded\n13. Confirmed positive drugs of abuse test result\n14. Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) antibody results\n15. Evidence of renal impairment at screening, as indicated by an estimated eGFR of \\<60 mL/min/1.73m2 using the Chronic Kidney Disease Epidemiology Collaboration equation\n16. History of clinically significant cardiovascular, renal, hepatic, dermatological, chronic respiratory or gastrointestinal disease, malabsorptive, neurological or psychiatric disorder, as judged by the investigator\n17. Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients\n18. Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hay fever is allowed unless it is active\n19. Donation of blood or plasma within the previous 3 months or loss of greater than 400 mL of blood\n20. Subjects who have taken known strong or moderate CYP3A4 inducers in the 30 days before IMP administration\n21. Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedies (other than up to 4 g of paracetamol per day) in the 14 days before study drug administration. Exceptions may apply, as determined by the investigator, if each of the following criteria are met: medication with a short half-life if the washout is such that no pharmacodynamic activity is expected by the time of dosing with study drug; and if the use of medication does not jeopardize the safety of the trial subject; and if the use of medication is not considered to interfere with the objectives of the study\n22. Subjects who have had a COVID-19 vaccine 7 days before dosing"}, 'identificationModule': {'nctId': 'NCT05737433', 'briefTitle': 'Single Dose ADME Study of [14C]-Rencofilstat in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hepion Pharmaceuticals, Inc.'}, 'officialTitle': 'An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-Rencofilstat in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'HEPA-CRV431-105'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]-RCF 225mg', 'description': '\\[14C\\]-rencofilstat, 225mg oral dose, self-micro-emulsifying drug delivery system, single dose', 'interventionNames': ['Drug: [14C]-rencofilstat 225mg']}], 'interventions': [{'name': '[14C]-rencofilstat 225mg', 'type': 'DRUG', 'otherNames': ['CRV431'], 'description': 'radio-labelled 225mg oral dose of rencofilstat', 'armGroupLabels': ['[14C]-RCF 225mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Quotient Sciences', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}], 'overallOfficials': [{'name': 'Litza McKenzie, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Quotient Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hepion Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}