Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-02-20 @ 6:01 PM
Study NCT ID:
NCT02695004
Status:
COMPLETED
Last Update Posted:
2020-04-06
First Post:
2016-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-02', 'studyFirstSubmitDate': '2016-02-18', 'studyFirstSubmitQcDate': '2016-02-29', 'lastUpdatePostDateStruct': {'date': '2020-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUC', 'timeFrame': '1056h', 'description': '0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h'}, {'measure': 'Cmax', 'timeFrame': '1056h', 'description': '0, 0.5, 1, 2, 4, 6, 8, 12, 24, 48, 72, 96, 120, 168, 240, 312, 360, 408, 432, 456, 480, 504, 528, 552, 600, 720, 816, 888, 960, 1056h'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'This is a study to evaluate safety, tolerability and PK of DKF-310 IM injection in healthy male volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Men aged 19 to 50 years\n* Body weight 55 to 90 kg and BMI 18.0 to 27.0\n* Voluntarily signed the informed consent form\n* Eligible according to the screening test results\n* Available to follow up after drop-out\n\nExclusion Criteria:\n\n* Clinically significant disorders or a medical history of hepatic, renal, neurological, respiratory, endocrine, hemato-oncologic, cardiovascular, urological and psychiatric diseases\n* Hypersensitivity to donepezil, piperidine derivatives and other drugs\n* SBP \\<100 mmHg or \\>150 mmHg, or DBP \\<60 mmHg or \\>100 mmHg\n* Skin and muscle disorders or history of surgery at the injection site\n* AST or ALT \\>1.5xULN; QT/QTcB interval \\>450 ms\n* History or positive result of drug abuse\n* Prescribed drugs or herbal medicines within 2 weeks, over-the-counter drugs or vitamins within 1 week\n* Participated in other clinical trials within 3 months\n* Donated whole blood within 2 months or apheresis within 1 month, or transfusion within 1 month\n* Alcohol consumption \\>21 units/week\n* Smoked \\>10 cigarettes/day within 3 months\n* Caffeine-containing foods\n* Not eligible due to other reasons at the investigator's discretion"}, 'identificationModule': {'nctId': 'NCT02695004', 'briefTitle': 'Safety, Tolerability and Pharmacokinetics of DKF-310 ( (Donepezil).', 'organization': {'class': 'INDUSTRY', 'fullName': 'Dongkook Pharmaceutical Co., Ltd.'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Phase 1 Clinical Trial to Evaluate Safety, Tolerability and Pharmacokinetics of DKF-310 Intramuscular Injection in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'DKF-310-P1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Donepezil 35 mg', 'description': 'Donepezil 35 mg or placebo', 'interventionNames': ['Drug: DKF-310', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Donepezil 70 mg', 'description': 'Donepezil 70 mg or placebo', 'interventionNames': ['Drug: DKF-310', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Donepezil140 mg', 'description': 'Donepezil 140 mg or placebo', 'interventionNames': ['Drug: DKF-310', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Donepezil 210 mg', 'description': 'Donepezil 210 mg or placebo', 'interventionNames': ['Drug: DKF-310', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Donepezil 280 mg', 'description': 'Donepezil 280 mg or placebo', 'interventionNames': ['Drug: DKF-310', 'Drug: Placebo']}], 'interventions': [{'name': 'DKF-310', 'type': 'DRUG', 'otherNames': ['Donepezil'], 'armGroupLabels': ['Donepezil 210 mg', 'Donepezil 280 mg', 'Donepezil 35 mg', 'Donepezil 70 mg', 'Donepezil140 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Donepezil 210 mg', 'Donepezil 280 mg', 'Donepezil 35 mg', 'Donepezil 70 mg', 'Donepezil140 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seongnam', 'country': 'South Korea', 'facility': 'Seoul National Univ. Bundang Hospital', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dongkook Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}