Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-02-21 @ 10:12 PM
Study NCT ID:
NCT02623868
Status:
COMPLETED
Last Update Posted:
2016-01-20
First Post:
2015-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050171', 'term': 'Dyslipidemias'}], 'ancestors': [{'id': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000620552', 'term': 'CKD-519'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-17', 'studyFirstSubmitDate': '2015-10-23', 'studyFirstSubmitQcDate': '2015-12-03', 'lastUpdatePostDateStruct': {'date': '2016-01-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 'Tmax of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 'AUClast of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 'AUC0-∞ of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 't1/2 of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 'CL/F of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 'Vd/F of CKD-519', 'timeFrame': '0h, 1h, 2h, 3h, 4h, 5h, 6h, 7h, 8h, 10h, 12h, 24h, 48h, 72h, 96h, 144h'}, {'measure': 'Emax of CKD-519 CETP(Cholesteryl ester transfer protein) Activity', 'timeFrame': '0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h'}, {'measure': 'Tmax of CKD-519 CETP Activity', 'timeFrame': '0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h'}, {'measure': 'AUEC of CKD-519 CETP Activity', 'timeFrame': '0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h'}, {'measure': 'EC50(half maximal effective concentration ) of CKD-519 CETP Activity', 'timeFrame': '0h, 1h, 2h, 4h, 6h, 8h, 10h, 12h, 16h, 24h, 48h, 72h'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Dyslipidemia']}, 'descriptionModule': {'briefSummary': 'Study to assess the pharmacokinetic/pharmacodynamic characteristics and safety/tolerability to CKD-519 new formulation in healthy male subjects.', 'detailedDescription': 'Open-label, Randomized, 3-period, 6-sequence, crossover study'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Between 20 aged and 45 aged in healthy male adult\n2. Body weight ≥ 50kg and in the range of calculated BMI(Body Mass Index) 18\\~29kg/m2\n3. Subject who sign on an informed consent form willingly\n4. Necessarily he agrees that use double contraceptions and do not sperm donation until two months during clinical trials and after the final dosage of investigational products\n\nExclusion Criteria:\n\n1. Clinically significant disease with cardiovascular, respiratory, hepatobiliary, nephrological, hematological, gastrointestinal, endocrine, immune, integumentary, neurologic, psychiatric system\n2. Have a acute disease within 28 days before the beginning of study treatment\n3. Have a disease history that can effect drug absorption, distribution, metabolism, excretion\n4. Have a clinically significant chronic disease\n5. Systolic blood pressure \\<100mmHg or \\>140mmHg, diastolic blood pressure\\<60mmHg or \\>90mmHg\n6. Positive for serology test (HBsAg, anti-HCV Ab, anti-HIV Ab, VDRL(Venereal Disease Research Laboratories))\n7. Subject treated ethical drug within 14 days before the beginning of study treatment\n8. Subject treated over-the-counter or herbal medicine within 7 days before the beginning of study treatment\n9. Have a clinically significant allergic disease (except for mild allergic rhinitis, allergic dermatitis with no drugs)\n10. Cannot take standard Meal\n11. Whole blood donation within 60 days prior to the first dosing or component blood donation within 20 days prior to the first dosing\n12. Blood transfusion within 30 days\n13. Taking drugs have received any other investigational drug within 90 days prior to the first dosing\n14. Continuously taking caffeine(\\>5 cups/day), drinking alcohol(\\>30g/day), smoking excessive cigarettes(\\>10cigarettes/day)\n15. Impossible on who participants in clinical trial by investigator's decision including laboratory test result or another reasone(for example, noncompliance, a disobliging manner)\n16. Subject treated metabolizing enzyme inducers or inhibitors including barbiturates within 30 days"}, 'identificationModule': {'nctId': 'NCT02623868', 'briefTitle': 'Study to Assess PK/PD Character, Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subject.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'Clinical Trial to Assess the Pharmacokinetic/Pharmacodynamic Characteristics and Safety/Tolerability of CKD-519 New Formulation in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '148NF15010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'A-B-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)', 'interventionNames': ['Drug: CKD-519 50mg 2Tabs.', 'Drug: CKD-519 100mg 1Tab.', 'Drug: CKD-519 100mg 1Cap.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'B-C-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)', 'interventionNames': ['Drug: CKD-519 50mg 2Tabs.', 'Drug: CKD-519 100mg 1Tab.', 'Drug: CKD-519 100mg 1Cap.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'C-A-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)', 'interventionNames': ['Drug: CKD-519 50mg 2Tabs.', 'Drug: CKD-519 100mg 1Tab.', 'Drug: CKD-519 100mg 1Cap.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'A-C-B (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)', 'interventionNames': ['Drug: CKD-519 50mg 2Tabs.', 'Drug: CKD-519 100mg 1Tab.', 'Drug: CKD-519 100mg 1Cap.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 5', 'description': 'B-A-C (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)', 'interventionNames': ['Drug: CKD-519 50mg 2Tabs.', 'Drug: CKD-519 100mg 1Tab.', 'Drug: CKD-519 100mg 1Cap.']}, {'type': 'EXPERIMENTAL', 'label': 'Group 6', 'description': 'C-B-A (Drug A: CKD-519 50mg 2Tabs. /Drug B: CKD-519 100mg 1Tab. /Drug C: CKD-519 100mg 1Cap.)', 'interventionNames': ['Drug: CKD-519 50mg 2Tabs.', 'Drug: CKD-519 100mg 1Tab.', 'Drug: CKD-519 100mg 1Cap.']}], 'interventions': [{'name': 'CKD-519 50mg 2Tabs.', 'type': 'DRUG', 'otherNames': ['Drug A'], 'description': 'after taking Standard meal, CKD-519 50mg 2Tabs. administration.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'CKD-519 100mg 1Tab.', 'type': 'DRUG', 'otherNames': ['Drug B'], 'description': 'after taking Standard meal, CKD-519 100mg 1Tab. administration.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}, {'name': 'CKD-519 100mg 1Cap.', 'type': 'DRUG', 'otherNames': ['Drug C'], 'description': 'after taking Standard meal, CKD-519 100mg 1Cap. administration.', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4', 'Group 5', 'Group 6']}]}, 'contactsLocationsModule': {'locations': [{'zip': '136-705', 'city': 'Seoul', 'state': 'Sungbuk-gu', 'country': 'South Korea', 'facility': 'Korea university medical center', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Ji Young Kim, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Korea University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}