Ignite Creation Date:
2025-12-25 @ 4:41 AM
Ignite Modification Date:
2026-03-06 @ 7:40 PM
Study NCT ID:
NCT03000218
Status:
UNKNOWN
Last Update Posted:
2016-12-23
First Post:
2016-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014580', 'term': 'Ursodeoxycholic Acid'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D003840', 'term': 'Deoxycholic Acid'}, {'id': 'D002793', 'term': 'Cholic Acids'}, {'id': 'D001647', 'term': 'Bile Acids and Salts'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D002757', 'term': 'Cholanes'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'lastUpdateSubmitDate': '2016-12-22', 'studyFirstSubmitDate': '2016-06-21', 'studyFirstSubmitQcDate': '2016-12-19', 'lastUpdatePostDateStruct': {'date': '2016-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid', 'timeFrame': 'Day 1, 15, 29, 57 predose (0h), Day 29 1, 2, 3, 4h'}, {'measure': 'Change from Baseline Low-density lipoprotein cholesterol at 8 weeks', 'timeFrame': 'Day 1, 29, 57, 71 predose (0h)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Overweight', 'Abnormal Liver Function Tests']}, 'descriptionModule': {'briefSummary': 'A clinical study to evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid multiple administration', 'detailedDescription': 'This study has a randomized, open-label, three-treatment, one-sequence, placebo-controlled, multiple drug administration design. The purpose of this study is as follows; To evaluate pharmacokinetics, metabolomics and biomarker in subjects who are overweight and have liver problems after ursodeoxycholic acid administration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Subjects aged 18 - 50 years\n* A body mass index (BMI) in the range of 25.0 kg/m2 - 30.0 kg/m2.\n* A alanine aminotransferase (ALT) in the range of 40 - 200 IU/L\n* Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations.\n\nExclusion Criteria:\n\n* Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor\n* Subject judged not eligible for study participation by investigator'}, 'identificationModule': {'nctId': 'NCT03000218', 'briefTitle': 'Evaluation of PK and Biomarkers After UDCA Administrations to Subjects Who Are Overweight and Have Liver Problems', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'Clinical Study Evaluating Pharmacokinetics and Biomarkers After Ursodeoxycholic Acid (UDCA) Administration to Subjects Who Are Overweight and Have Liver Problems', 'orgStudyIdInfo': {'id': 'UDCA_overweight_LFTabnormal'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'UDCA 8 wks', 'description': 'Day 1 to 56: Ursodeoxycholic acid 300mg bid', 'interventionNames': ['Drug: Ursodeoxycholic acid']}, {'type': 'EXPERIMENTAL', 'label': 'UDCA for 4wks/UDCA+metformin for 4wks', 'description': 'Day 1 to 28: Ursodeoxycholic acid 300mg bid Day 29 to 56: Ursodeoxycholic acid 300mg and Metformin 500mg bid', 'interventionNames': ['Drug: Ursodeoxycholic acid', 'Drug: Metformin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Day 1 to 56: Placebo bid', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Ursodeoxycholic acid', 'type': 'DRUG', 'otherNames': ['Ursa tab'], 'description': 'Ursodeoxycholic acid 300mg bid for 8 weeks', 'armGroupLabels': ['UDCA 8 wks', 'UDCA for 4wks/UDCA+metformin for 4wks']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Diabex tab'], 'description': 'Day 29 to 56: Metformin 500mg bid', 'armGroupLabels': ['UDCA for 4wks/UDCA+metformin for 4wks']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Day 1 to 56: Placebo bid', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Jae-Yong Chung, MD, PhD', 'role': 'CONTACT', 'phone': '+82-031-787-3955'}, {'name': 'Jae-Yong Chung, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Seoul National University Bundang Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'So Hee Jung', 'role': 'CONTACT', 'phone': '+82-31-787-3968'}, {'name': 'Heecahn Lee', 'role': 'CONTACT', 'phone': '+82-2-2072-4083'}], 'overallOfficials': [{'name': 'Jae-Yong Chung, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jae Yong Chung, MD, PhD', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}