Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT04927793
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2021-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000723099', 'term': 'EDP-938'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-21', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-15', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of EDP-938 in plasma', 'timeFrame': 'Up to 11 days'}, {'measure': 'AUC0-tlast of EDP-938 in plasma', 'timeFrame': 'Up to 11 days'}, {'measure': 'AUC-inf in plasma', 'timeFrame': 'Up to 11 days'}, {'measure': 'Amount excreted in urine (Aeu)', 'timeFrame': 'Up to 11 days'}, {'measure': 'Amount excreted in feces (Aef)', 'timeFrame': 'Up to 11 days'}, {'measure': 'Cmax of EDP-938 metabolites in plasma', 'timeFrame': 'Up to 11 days'}], 'secondaryOutcomes': [{'measure': 'Safety measured by occurrence of adverse events', 'timeFrame': 'Up to 11 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AME Study'], 'conditions': ['Respiratory Syncytial Virus (RSV)']}, 'descriptionModule': {'briefSummary': 'A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \\[14C\\]EDP-938 in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Males of any ethnic origin, between 18 and 55 years of age, inclusive.\n* Able to comprehend and willing to sign an Informed Consent Form\n* In good health, determined by no clinically significant findings from medical history, physical examination (check-in only), 12-lead ECG, vital signs measurements, and clinical laboratory evaluations\n\nExclusion Criteria:\n\n* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).\n* History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).\n\n a. Subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded.\n* Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.\n* A body surface area-adjusted estimated glomerular filtration rate (eGFR) ≤ 90 mL/min per 1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, at screening'}, 'identificationModule': {'nctId': 'NCT04927793', 'briefTitle': 'Absorption, Metabolism, and Excretion (AME) Study of [14C]EDP-938 in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Enanta Pharmaceuticals, Inc'}, 'officialTitle': 'A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]EDP-938 Following a Single Oral Dose in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'EDP 938-009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm EDP-938', 'interventionNames': ['Drug: EDP-938']}], 'interventions': [{'name': 'EDP-938', 'type': 'DRUG', 'description': '\\[14C\\]EDP-938', 'armGroupLabels': ['Single arm EDP-938']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53704', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Covance Clinical Research Unit', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Enanta Pharmaceuticals, Inc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Enanta Pharmaceuticals, Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Enanta Pharmaceuticals, Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}