Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-29 @ 2:18 AM
Study NCT ID:
NCT02167061
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2014-06-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C557982', 'term': '4-(3-amino-4-(2,4,5-trifluorophenyl)butanoyl)-3-(tert-butoxymethyl)piperazin-2-one'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-27', 'studyFirstSubmitDate': '2014-06-11', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve(AUC)last of Evogliptin and Metformin', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose'}, {'measure': 'Maximum of concentration (Cmax) of Evogliptin and Metformin', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose'}], 'secondaryOutcomes': [{'measure': 'Time of maximum concentration(Tmax) of Evogliptin and Metformin', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose'}, {'measure': 'Terminal half-life(t1/2) of Evogliptin and Metformin', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose'}, {'measure': 'Apparent Clearance(CL/F) of Evogliptin and Metformin', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose'}, {'measure': 'Area Under Curve(AUC)inf of Evogliptin and Metformin', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose', 'description': 'AUCinf = AUC last + Clast/λz'}, {'measure': 'Time prior to the first measurable concentration (tlag) of Metformin (only in Part 2 trial)', 'timeFrame': '1d(15d) pre-dose, 1,2,3,4,5,6,7,8,10,12,15,24,36,48,60,72h post-dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'This Phase I clinical study is to evaluate the safety/tolerability and pharmacokinetics of DA-1229\\_01 and to investigate the effect of food on the pharmacokinetics of DA-1229\\_01 in healthy male volunteers'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 20 to 45, healthy male subjects(at screening)\n* Body weight between 55kg - 90kg, BMI between 18.0 - 27.0\n* FPG 60-125mg/dL glucose level(at screening)\n* Volunteer who totally understands the progress of this clinical trials, make decision by his free will, and signed a consent form to follow the progress.\n\nExclusion Criteria:\n\n* Volunteer who has past or present history of any diseases following below.(liver including hepatitis virus carrier, kidney, Neurology, immunology, pulmonary, endocrine, hematooncology, cardiology, mental disorder)\n* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)\n* Volunteer who had drug(Aspirin, antibiotics) hypersensitivity reaction\n* Subject who already participated in other trials in 2 months\n* Subject who had whole blood donation in 2 months, or component blood donation in 1 months or transfusion"}, 'identificationModule': {'nctId': 'NCT02167061', 'briefTitle': 'A Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01 Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000 mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Crossover, Single Dose Clinical Trial to Investigate Safety/Tolerability and Pharmacokinetics of DA-1229_01(Evogliptin/Metformin XR 5/1000 mg) Compared to Co-administration of Evogliptin 5 mg and Metformin XR 1000mg, and to Evaluate the Effect of Food on the Pharmacokinetics of DA-1229_01 After Single Oral Administration in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DA1229_01_BE_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(Part 1) DA-1229_01 → E+M', 'description': 'DA-1229\\_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg', 'interventionNames': ['Drug: DA-1229_01', 'Drug: E+M']}, {'type': 'EXPERIMENTAL', 'label': '(Part 1) E+M → DA-1229_01', 'description': 'DA-1229\\_01 : Evogliptin/Metformin XR 5/1000mg E : Evogliptin 5 mg M : Metformin XR 1000 mg', 'interventionNames': ['Drug: DA-1229_01', 'Drug: E+M']}, {'type': 'EXPERIMENTAL', 'label': '(Part 2) DA-1229_01 fast → fed', 'description': 'DA-1229\\_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet', 'interventionNames': ['Drug: DA-1229_01 fast', 'Drug: DA-1229_01 fed']}, {'type': 'EXPERIMENTAL', 'label': 'DA-1229_01 fed → fast', 'description': 'DA-1229\\_01 : Evogliptin/Metformin XR 5/1000mg Fast : administration on an empty stomach Fed: administration after high-fat diet', 'interventionNames': ['Drug: DA-1229_01 fast', 'Drug: DA-1229_01 fed']}], 'interventions': [{'name': 'DA-1229_01', 'type': 'DRUG', 'otherNames': ['Evogliptin/Metformin XR 5/1000 mg'], 'description': 'complex single administration', 'armGroupLabels': ['(Part 1) DA-1229_01 → E+M', '(Part 1) E+M → DA-1229_01']}, {'name': 'E+M', 'type': 'DRUG', 'otherNames': ['Evogliptin 5 mg + Metformin XR 1000 mg'], 'description': 'co-administration of 2 drugs', 'armGroupLabels': ['(Part 1) DA-1229_01 → E+M', '(Part 1) E+M → DA-1229_01']}, {'name': 'DA-1229_01 fast', 'type': 'DRUG', 'armGroupLabels': ['(Part 2) DA-1229_01 fast → fed', 'DA-1229_01 fed → fast']}, {'name': 'DA-1229_01 fed', 'type': 'DRUG', 'armGroupLabels': ['(Part 2) DA-1229_01 fast → fed', 'DA-1229_01 fed → fast']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Clinical Trial Center, Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Kyung-sang Yu, Ph.d., M.B.A', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}