Ignite Creation Date:
2025-12-25 @ 3:45 AM
Ignite Modification Date:
2026-02-22 @ 7:11 AM
Study NCT ID:
NCT02267902
Status:
UNKNOWN
Last Update Posted:
2014-10-20
First Post:
2014-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-10-15', 'studyFirstSubmitDate': '2014-10-13', 'studyFirstSubmitQcDate': '2014-10-15', 'lastUpdatePostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the absolute bioavailability of DA-1229 (F)', 'timeFrame': '240 hours'}, {'measure': 'The mass balance recovery (Ae, %Ae)', 'timeFrame': '240 hours'}]}, 'conditionsModule': {'keywords': ['Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The objectives of this study are to evaluate the absolute bioavailability, and absorption and excretion of DA-1229, an IMP in clinical assessment for the treatment of T2DM. The oral and IV PK of DA-1229 will also be evaluated. The metabolism of DA-1229 may also be evaluated.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy males\n* Age 18 to 55\n* BMI 18.0 to 30.0 kg/㎡\n\nExclusion Criteria:\n\n* History of any drug or alcohol abuse in the past 2years\n* Regular alcohol consumption nin males \\>21 units per week\n* Current smokers and those who have smoked within the last 12months\n* Radiation Exposure\n* Positive drugs of abuse test result\n* Positive HBsAg, HCV Ab, HIV results\n* Serious adverse reaction or hypersensitivity to any drug of the formulation excipients\n* Clinically significant allergy\n* Donation of loss of blood within the previous 3 months\n* Taking any prescribed or OTC drug or herbal remedies in the 14days before IMP administration'}, 'identificationModule': {'nctId': 'NCT02267902', 'briefTitle': 'Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism, Excretion of DA-1229', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Phase I, Open-Label, 2-Part Microtracer Study to Establish Absolute Bioavailability and the Absorption, Metabolism and Excretion of DA-1229 in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'DA1229_BAMB_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1', 'description': 'Single oral therapeutic dose of 5mg DA-1229 as a tablet + An IV dose of 20㎍ \\[14C\\]-DA-1229', 'interventionNames': ['Drug: DA-1229']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Single oral therapeutic dose of 5mg \\[14C\\]-DA-1229', 'interventionNames': ['Drug: DA-1229']}], 'interventions': [{'name': 'DA-1229', 'type': 'DRUG', 'armGroupLabels': ['Part 1', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'state': 'Ruddington', 'country': 'United Kingdom', 'facility': 'Quotient Clinical', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dong-A ST Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}