Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 5:28 PM
Study NCT ID:
NCT03175835
Status:
COMPLETED
Last Update Posted:
2017-07-07
First Post:
2017-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects
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': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'C000620552', 'term': 'CKD-519'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-05', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-06-02', 'lastUpdatePostDateStruct': {'date': '2017-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetics (Area under the plasma concentration versus time curve (AUCτ))', 'timeFrame': '0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}], 'secondaryOutcomes': [{'measure': 'Pharmacokinetics (Peak plasma Concentration (Cmax,ss))', 'timeFrame': '0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}, {'measure': 'Pharmacokinetics (Minimum plasma Concentration (Cmin,ss))', 'timeFrame': '0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}, {'measure': 'Pharmacokinetics (Time to maximum plasma concentration (Tmax,ss))', 'timeFrame': '0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}, {'measure': 'Pharmacokinetics (t1/2)', 'timeFrame': '0(predose)~24 hours at Day1, Day3, Day4, Day5, Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}, {'measure': 'Pharmacodynamics (CETP activity)', 'timeFrame': '0(predose)~24 hours at Day9, Day12, Day15, Day17, Day18, Day19, Day22, Day24, Day25, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}, {'measure': 'Pharmacodynamics (CETP Concentration)', 'timeFrame': '0(predose)~24 hours at Day9, Day19, Day22, Day26', 'description': 'At steady state after multiple administration of CKD-519, Rosuvastatin'}, {'measure': 'Pharmacodynamics (Lipid profiles)', 'timeFrame': 'simultaneous with laboratory test at Day1, Day6, Day9, Day20, Day22, Day27'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dyslipidemia', 'CKD-519', 'Rosuvastatin', 'Drug-Drug Interaction'], 'conditions': ['Dyslipidemias']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.', 'detailedDescription': 'An open-label, multiple dose, fixed-sequence, 3-period study to evaluate the drug interaction between CKD-519 and rosuvastatin in healthy male subjects.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy volunteers aged between ≥ 20 and ≤ 45 years old\n2. Weight ≥ 50kg, with calculated body mass index(BMI) of ≥ 18 and ≤ 29.9kg/m²\n3. Subjects to consents to use effective birth controls for at least 2 months following the last dose\n4. Subject is informed of the investigational nature of this study and voluntarily agrees to participate in this study and comply with the relevant instructions in written\n\nExclusion Criteria:\n\n1. History or presence of clinically significant and active cardiovascular, respiratory, hepatobiliary, renal, endocrine, hematological, gastrointestinal, neurologic, immune, dermatologic or psychiatric disorder\n2. With symptoms indicating acute illness within 28 days prior to the first Investigational Product administration\n3. Any medical history that may affect drug absorption, distribution, metabolism and excretion\n4. Any hypersensitivity reaction or clinically significant hypersensitivity reaction in the history of statin-related medication or Cholesteryl Ester Transfer Protein(CETP) inhibitor or other drugs(aspirin, antibiotics)\n5. Continuous cryptogenic elevation of serum transaminase or active liver disease including elevation of serum transaminase \\> 3 fold upper normal limit(UNL)\n6. Severe renal failure(creatinin clearance \\< 30 ml/min)\n7. Hypothyroidism or clinically significant test result\n8. Galactose intolerance, Lapp lactose intolerance, glucose-galactose malabsorption or genetic disorders\n9. Any clinically significant chronic medical illness\n10. Any clinically significant hypotension or hypertension (systolic \\< 100 mmHg/diastolic \\< 60 mmHg or systolic \\> 140 mmHg /diastolic \\> 90 mmHg)\n11. Corrected QT interval(QTc) \\>450msec on 12-lead ECG\n12. Positive blood tests for hemoglobins(HBs) Ag, anti-hepatitis C virus(HCV) Ab, anti-HIV Ab, or venereal disease research laboratory(VDRL)\n13. Creatine phosphokinase(CPK) ≥ 5 fold of upper normal limit(UNL)\n14. Use of any prescription drugs within 14 days prior to study drug administration\n15. Use of any other drugs, including over-the-counter medications and herbal preparations within 7 days prior to study drug administration\n16. History of clinically significant allergic reaction (However, mild allergic rhinitis or allergic dermatitis which do not require any treatment may be allowed)\n17. Inability to take normal hospital diet\n18. Donation of blood within 60 days prior to study drug administration or plasma to a blood bank within 20 days prior to study drug administration\n19. Blood transfusion within 30 days prior to study drug administration\n20. Exposure to any investigational drug or placebo within 90 days prior to the first Investigational Product(IP) administration\n21. Subjects taking any drugs to induce or inhibit drug metabolizing enzymes including barbiturates within 30 days prior to the first Investigational Product(IP) administration\n22. Subjects with excessive caffeine intake (more than 5 cups/day), heavy smoking (more than 10 cigarettes/day), regular alcohol intake (more than 210 g/week)\n23. Subjects having been deemed inappropriate for the trial as determined by the investigator'}, 'identificationModule': {'nctId': 'NCT03175835', 'briefTitle': 'Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chong Kun Dang Pharmaceutical'}, 'officialTitle': 'An Open-label, Multiple Dose, Fixed-sequence, 3-period Study to Evaluate the Drug Interaction Between CKD-519 and Rosuvastatin in Healthy Male Subjects', 'orgStudyIdInfo': {'id': '148DDI16023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin 20 mg & CKD-519 200 mg', 'description': 'Period 1: Treatment A(Rosuvastatin 20 mg(20 mg X 1 tablet))\n\nPeriod 2: Treatment B(CKD-519 200 mg(100 mg X 2 tablets))\n\nPeriod 3: Treatment C(Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets))', 'interventionNames': ['Drug: Rosuvastatin 20 mg', 'Drug: CKD-519 200 mg', 'Drug: Rosuvastatin 20 mg & CKD-519 200 mg']}], 'interventions': [{'name': 'Rosuvastatin 20 mg', 'type': 'DRUG', 'otherNames': ['Rosuvastatin 20 mg(20 mg X 1 tablet)'], 'description': 'Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1\\~Day5', 'armGroupLabels': ['Rosuvastatin 20 mg & CKD-519 200 mg']}, {'name': 'CKD-519 200 mg', 'type': 'DRUG', 'otherNames': ['CKD-519 200 mg(100 mg X 2 tablets)'], 'description': 'Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9\\~Day21', 'armGroupLabels': ['Rosuvastatin 20 mg & CKD-519 200 mg']}, {'name': 'Rosuvastatin 20 mg & CKD-519 200 mg', 'type': 'DRUG', 'otherNames': ['Rosuvastatin 20 mg(20 mgX1 tablet), CKD-519 200 mg(100 mgX2 tablets)'], 'description': 'Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22\\~Day26', 'armGroupLabels': ['Rosuvastatin 20 mg & CKD-519 200 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Korea University Anam Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chong Kun Dang Pharmaceutical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}