Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2026-02-24 @ 10:20 PM
Study NCT ID:
NCT02819934
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2016-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study to Investigate the ADME of KD101
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2018-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-17', 'studyFirstSubmitDate': '2016-05-30', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total radioactivity at feces,urine,blood to measure total recovery rate', 'timeFrame': '13day', 'description': 'radioactivity in nCi'}]}, 'conditionsModule': {'conditions': ['Obesity']}, 'descriptionModule': {'briefSummary': 'A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects', 'detailedDescription': 'A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Are able to provide written informed consent\n* The subject is a healthy Korean aged 20 to 55 years, inclusive.\n* The subject weighs at least 55 and has a body mass index (BMI)over 27\n\nExclusion Criteria:\n\n* Subjects with evidence or a history of clinically significant pulmonary, cardiovascular, hepatic, endocrine, hematological, neurologic or psychiatric diseases.\n* Subjects with evidence of gastrointestinal disease which can affect the absorption of drug.\n* Subjects with a history of drug abuse or a positive result in the urine drug screening for drug abuse\n* Subjects who have taken any prescribed medicine or herbal medicine within 2 weeks before the first administration of the investigational product, any non-prescribed medicine or vitamin supplement within 1 week prior the first administration of the investigational product (if all other conditions are satisfied, subjects may be eligible for the trial as judged by the investigator.)\n* Subjects who have donated a unit of whole blood within 30 days or who have participated in any other clinical trial within 60 days prior the first administration of the investigational product\n* Subject who have history of allergy.\n* Subject who can not continue proper contraception method during study period.\n* Subjects who consume more than 21 units of alcohol per week (1 unit = 10 g of pure alcohol) or who are unable to abstain from drinking during the PK/PD testing period\n* Subjects who are unable to abstain from smoking during the PK/PD testing period\n* Subjects who are unable to abstain from grapefruit or caffeine containing food 1 day prior the first administration of the investigational product\n* Subjects judged not eligible for the study after reviewing the clinical laboratory results or other reasons by the investigator.'}, 'identificationModule': {'nctId': 'NCT02819934', 'briefTitle': 'A Phase I Study to Investigate the ADME of KD101', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'A Phase I Study to Investigate the Absorption, Metabolism, and Excretion of KD101 in Male Subjects', 'orgStudyIdInfo': {'id': 'KD101_hAME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm1', 'description': 'experimental group', 'interventionNames': ['Drug: KD101']}], 'interventions': [{'name': 'KD101', 'type': 'DRUG', 'description': 'after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral', 'armGroupLabels': ['Arm1']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD', 'investigatorFullName': 'Howard Lee', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}