Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2026-01-01 @ 9:50 PM
Study NCT ID:
NCT06645704
Status:
COMPLETED
Last Update Posted:
2025-02-24
First Post:
2024-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
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': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2024-10-15', 'studyFirstSubmitQcDate': '2024-10-15', 'lastUpdatePostDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mass balance of [14C]-EP262', 'timeFrame': 'Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)', 'description': 'Assessed by the total recovery of radioactivity from urine and feces'}, {'measure': 'Pharmacokinetics (PK) of EP262 and [14C]', 'timeFrame': 'Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)', 'description': 'Assessed by the concentration of EP262 in plasma and \\[14C\\] in whole blood, plasma, urine, and feces'}], 'secondaryOutcomes': [{'measure': 'Metabolite profile of EP262', 'timeFrame': 'Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)', 'description': 'Assessed by the concentration of EP262 metabolites in plasma, urine, and feces'}, {'measure': 'Safety and tolerability of [14C]-EP262', 'timeFrame': 'Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)', 'description': 'Assessed by the incidence of treatment emergent adverse events, clinical laboratory evaluations, vital signs, 12-lead electrocardiogram, and physical examination findings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy Participants']}, 'descriptionModule': {'briefSummary': 'This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of \\[14C\\]-EP262 in healthy male participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males aged 18 to 55 years\n* Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg\n* Negative result for HIV, HBV, and HCV at Screening\n* Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control\n* No use of tobacco or nicotine containing products within the past 6 months\n\nExclusion Criteria:\n\n* History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator\n* History of malignancy within the past 5 years\n* History of any serious allergic reactions or hypersensitivity\n* Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void\n* Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day'}, 'identificationModule': {'nctId': 'NCT06645704', 'briefTitle': 'An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Escient Pharmaceuticals, Inc'}, 'officialTitle': 'An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration', 'orgStudyIdInfo': {'id': 'EP-262-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[14C]-EP262 25 mg', 'description': 'Administered orally.', 'interventionNames': ['Drug: EP262']}], 'interventions': [{'name': 'EP262', 'type': 'DRUG', 'description': 'Single dose of \\[14C\\]-EP262 administered orally.', 'armGroupLabels': ['[14C]-EP262 25 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Pharmaron Clinical Pharmacology Center (CPC)', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Escient Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}