Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2025-12-30 @ 8:05 AM
Study NCT ID:
NCT05657834
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2022-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose 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': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-23', 'studyFirstSubmitDate': '2022-12-12', 'studyFirstSubmitQcDate': '2022-12-12', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[14C]TVB-2640: AUC-inf in plasma', 'timeFrame': 'Up to 22 days'}, {'measure': '[14C]TVB-2640: Amount excreted in urine', 'timeFrame': 'Up to 22 days'}, {'measure': '[14C]TVB-2640: Amount excreted in feces', 'timeFrame': 'Up to 22 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Absorption', 'Metabolism', 'Excretion', 'Radiolabeled Dose', 'Mass Balance [14C]'], 'conditions': ['Healthy Volunteers']}, 'descriptionModule': {'briefSummary': 'A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \\[14C\\]TVB-2640 healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Males, of any race, between 19 and 55 years of age, inclusive.\n* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \\[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\\] is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee).\n* History of a minimum of 1 bowel movement per day\n\nKey Exclusion 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 corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities.\n* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).\n* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.\n* Use of any sensitive substrates of cytochrome P450 (CYP)2C9 or CYP3A4/5, or inhibitors of CYP3A4 within 30 days prior to IMP administration (Day 1).\n* Donation or loss of ≥ 550 mL blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening."}, 'identificationModule': {'nctId': 'NCT05657834', 'briefTitle': 'Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sagimet Biosciences Inc.'}, 'officialTitle': 'A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-TVB-2640 Following a Single Oral Dose in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'SB2640-CLIN-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 1', 'description': 'Single dose of TVB-2640, 50 mg, oral administration', 'interventionNames': ['Drug: [14C]-TVB-2640']}], 'interventions': [{'name': '[14C]-TVB-2640', 'type': 'DRUG', 'description': '50 mg of TVB-2640 oral administration', 'armGroupLabels': ['Treatment Arm 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68502', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Celerion Inc.', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sagimet Biosciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}