Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT02557594
Status:
COMPLETED
Last Update Posted:
2017-04-12
First Post:
2015-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068698', 'term': 'Tenofovir'}], 'ancestors': [{'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2016-03-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-10', 'studyFirstSubmitDate': '2015-09-22', 'studyFirstSubmitQcDate': '2015-09-22', 'lastUpdatePostDateStruct': {'date': '2017-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-11-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under Curve(AUC)last of Tenofovir', 'timeFrame': '0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose'}, {'measure': 'Maximum of concentration(Cmax) of Tenofovir', 'timeFrame': '0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose'}], 'secondaryOutcomes': [{'measure': 'Time of maximum concentration(Tmax) of Tenofovir', 'timeFrame': '0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose'}, {'measure': 'Terminal half-life(t1/2) of Tenofovir', 'timeFrame': '0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose'}, {'measure': 'Apparent Clearance(CL/F) of Tenofovir', 'timeFrame': '0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose'}, {'measure': 'Area Under Curve(AUC)inf of Tenofovir', 'timeFrame': '0h(before admisitration), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, 72h post-dose'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis B'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This Phase I clinical study is to evaluate the safety and pharmacokinetics of DA-2802 319mg and Viread 300mg after a single oral dose in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 20 to 50, healthy male subjects(at screening)\n* Body weight over 55kg, BMI between 18.0 - 27.0\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, urinary, skeletomuscular, cardiovascular, mental disorder)\n* Volunteer who had GI tract disease(Crohn's disease, ulcer, acute or chronic pancreatitis) or surgery(appendectomy, hernioplasty are excluded)\n* Genetic disorders such as glucose-galactose malabsorption, Lapp lactose deficiency, galactose intolerance which is contraindication to Viread\n* Volunteer who had hypersensitivity reaction to medicines including Tenofovir, Aspirin, or antibiotics\n* exceed 1.5 times the normal range of AST, ALT at screening test before randomization\n* history of drug abuse, or a positive urine drug screen\n* having ETC drug or herbal medicines within 2 weeks before first administration or OTC drug or vitamin preparations within a week before first administration\n* Participation in any other clinical trial involving investigational drugs within 3 months\n* Volunteer who had whole blood donation in 2 months, or component blood donation or transfusion in 1 months\n* Regular alcohol consumption(over 21 units/week, 1unit=10g of pure alcohol) or volunteers who cannot abstain from drinking during the study\n* Volunteers smoking over 10 cigarettes per day or who cannot abstain from smoking during the study(from 24hr before admission to discharge)\n* Volunteers who had grapefruit containing foods from 24hr before admission to discharge or who cannot abstain from grapefruit containing foods\n* Volunteers who are not using adequate contraception methods or have a pregnancy plan\n* volunteers who cannot abstain from caffeine containing foods(coffee, tea, soft drinks etc) during the study\n* any condition that, in the view of the investigator, would interfere with study participation"}, 'identificationModule': {'nctId': 'NCT02557594', 'briefTitle': 'Clinical Trial to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg in Healthy Male Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dong-A ST Co., Ltd.'}, 'officialTitle': 'A Randomized, Open-label, Two-way Crossover Study to Assess the Safety and Pharmacokinetics of DA-2802 319mg and Viread 300mg After a Single Oral Dose in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DA2802_BE_I'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Viread → DA-2802', 'description': '* Viread 300mg(Tenofovir disoproxil fumarate)\n* DA-2802 319mg(Tenofovir disoproxil orotate)', 'interventionNames': ['Drug: Viread 300mg', 'Drug: DA-2802 319mg']}, {'type': 'EXPERIMENTAL', 'label': 'DA-2802 → Viread', 'description': '* Viread 300mg(Tenofovir disoproxil fumarate)\n* DA-2802 319mg(Tenofovir disoproxil orotate)', 'interventionNames': ['Drug: Viread 300mg', 'Drug: DA-2802 319mg']}], 'interventions': [{'name': 'Viread 300mg', 'type': 'DRUG', 'otherNames': ['Tenofovir disoproxil fumarate'], 'description': 'single dose administration after 10hr fasting', 'armGroupLabels': ['DA-2802 → Viread', 'Viread → DA-2802']}, {'name': 'DA-2802 319mg', 'type': 'DRUG', 'otherNames': ['Tenofovir disoproxil orotate'], 'description': 'single dose administration after 10hr fasting', 'armGroupLabels': ['DA-2802 → Viread', 'Viread → DA-2802']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', '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'}}}}