Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-01-07 @ 12:21 PM
Study NCT ID:
NCT03381703
Status:
COMPLETED
Last Update Posted:
2017-12-22
First Post:
2017-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000627745', 'term': 'YH12852'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-18', 'studyFirstSubmitDate': '2017-10-29', 'studyFirstSubmitQcDate': '2017-12-18', 'lastUpdatePostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity', 'timeFrame': '0 - 288 hours (post-dose)', 'description': 'Total radioactivity recovered'}, {'measure': 'Cmax of YH12852', 'timeFrame': '0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)', 'description': 'Peak concentration of YH12852'}, {'measure': 'AUClast of YH12852', 'timeFrame': '0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)', 'description': 'Area under the concentration-time curve from time 0 to the last measurable time of YH12852'}, {'measure': 'Fpo of YH12852', 'timeFrame': '0(pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288 hours (post-dose)', 'description': 'Oral bioavailability of YH12852'}], 'secondaryOutcomes': [{'measure': 'Aef of YH12852', 'timeFrame': '0 - 288 hours (post-dose)', 'description': 'Amount excreted in feces of YH12852'}, {'measure': 'Aeu of YH12852', 'timeFrame': '0 - 288 hours (post-dose)', 'description': 'Amount excreted in urine of YH12852'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Accelerated Mass Spectrometry', 'Microtracer', 'Microdose', 'hAME', 'Absolute bioavailability'], 'conditions': ['Constipation']}, 'descriptionModule': {'briefSummary': 'This study investigates the absorption, metabolism, and excretion and the absolute bioavailability of YH12852 in healthy male subjects', 'detailedDescription': 'Part 1 : Investigate the absorption metabolism, and excretion of YH12852 after single oral administration of YH12852 and 14C-labeled YH12852.\n\nPart 2\n\n: Investigate the absolute bioavailability of YH12852 after single oral administration of YH12852 followed by a single i.v. administration of 14C-labeled YH12852.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects who agreed to voluntarily participate in this study and comply with all the study requirements by signing informed consent form after being informed of the nature of this study and understanding all aspects of this study\n* Healthy adult, 19 - 55 of age (inclusive)\n* Subjects weighing over 55 kg (inclusive) with BMI between 18 and 25 (inclusive) at screening visit\n* Subjects with no clinically significant abnormal findings as determined by physical examination, ECG, medical history, or clinical laboratory test results\n\nExclusion Criteria:\n\n* History of clinically significant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorder\n* Surgery of the gastrointestinal tract that could interfere with kinetics of the study drug\n* History of (or suspected at screening visit) disease listed below Myocardial infarction Cerebral infarction/Stroke Arrythmia that need medical treatment Unstable angina Pulmonary hypertension\n* Subjects who are positive for Hepatitis B, Hepatitis C, and HIV\n* History of relevant allergy/hypersensitivity\n* Subjects who took prescribed medications within 14 days or over-the-counter (OTC) medications within 7 days prior to the first dose of the study drug\n* Subjects who have been consuming over 21 unit(1 unit = 10 g of alcohol) per week of alcohol prior to the study initiation or who is not able to stop consuming alcohol throughout the hospitalization period\n* Subjects who consumed products listed below within 2 days prior to the first dose of the study drug or who is not able to stop consuming products listed below until the last site visit Foods and/or beverages containing grapefruit Products containing caffeine (Coffee, tea, chocolate, caffeine-containing soft drinks)\n* Subject who is not willing to use contraception throughout the study\n* Subjects who have smoked over 10 cigarettes until 3 months prior to the study initiation or who is not able to stop smoking throughout the hospitalization period\n* Subjects who have donated whole blood within 2 months or blood component within 1 month or received blood transfusion within 1 month of participating in this study\n* Administration of any investigational products within 3 months from the first dose of the study drug\n* Subject who's serum prolactin is over 3-fold higher than the upper limit of normal range\n* Subject who judged not eligible for study participation by investigator"}, 'identificationModule': {'nctId': 'NCT03381703', 'briefTitle': 'Investigation of the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase I Study to Investigate the Absorption, Metabolism, and Excretion and the Absolute Bioavailability of YH12852 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'YH12852-103(I)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'Investigate the absorption, metabolism, and excretion of YH12852', 'interventionNames': ['Drug: YH12852', 'Drug: 14C-labeled YH12852']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Investigate the absolute bioavailability of YH12852', 'interventionNames': ['Drug: YH12852', 'Drug: 14C-labeled YH12852']}], 'interventions': [{'name': 'YH12852', 'type': 'DRUG', 'description': 'YH12852 administration', 'armGroupLabels': ['Part 1', 'Part 2']}, {'name': '14C-labeled YH12852', 'type': 'DRUG', 'description': '14C-labeled YH12852 administration', 'armGroupLabels': ['Part 1', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital Clinical Trial Center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Howard Lee, MD., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}