Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-01 @ 6:40 AM
Study NCT ID:
NCT04214808
Status:
COMPLETED
Last Update Posted:
2020-12-02
First Post:
2019-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Pharmacokinetics and Safety of AD-208
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000505', 'term': 'Alopecia'}], 'ancestors': [{'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-05-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2019-12-26', 'studyFirstSubmitQcDate': '2019-12-29', 'lastUpdatePostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of participants with adverse events', 'timeFrame': 'From Day -1 until Day 59', 'description': 'Incidence rate of adverse events'}], 'primaryOutcomes': [{'measure': 'Area under the curve in time plot (AUCt)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 'AUCt of the total ingredient of dutasteride'}, {'measure': 'Peak Plasma Concentration (Cmax)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 'Cmax of the total ingredient of dutasteride'}], 'secondaryOutcomes': [{'measure': 'Area under the curve in time plot (AUCinf)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 'AUCinf of the total ingredient of dutasteride'}, {'measure': 'Time to reach Cmax(Tmax)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 'Tmax of the total ingredient of dutasteride'}, {'measure': 'Effective half-life(t1/2)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 't1/2 of the total ingredient of dutasteride'}, {'measure': 'Clearance(CL/F)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 'CL/F of the total ingredient of dutasteride'}, {'measure': 'Volume of distribution(Vd/F)', 'timeFrame': 'Pre-dose(0 hour) to 72 hour', 'description': 'Vd/F of the total ingredient of dutasteride'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Androgenetic Alopecia']}, 'descriptionModule': {'briefSummary': 'To evaluate pharmacokinetics and safety of AD-208.', 'detailedDescription': 'The purpose is that pharmacokinetics and safety of AD-208 in healthy adult male volunteers are evaluated as compared to Avodart Soft Capsule 0.5mg.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male Adult aged between 19 to 50 at the time of screening visit\n* Weight over 50kg and Body mass index (BMI) between 17.5 kg/m2 and 30.5 kg/m2 at the time of screening visit\n* No evidence of medical symptoms or signs of congenital or no chronic disease\n\nExclusion Criteria:\n\n* If having a clinically significant disease or medical history for blood/tumor, genitourinary systen, liver/biliary system, kidney, respiratory system, alimentary system, endocrine system, immune system, cardiovascular system, nervous system, skin and psychical disorder, etc'}, 'identificationModule': {'nctId': 'NCT04214808', 'briefTitle': 'To Evaluate the Pharmacokinetics and Safety of AD-208', 'organization': {'class': 'INDUSTRY', 'fullName': 'Addpharma Inc.'}, 'officialTitle': 'A Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of AD-208', 'orgStudyIdInfo': {'id': 'AD-208PK'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avodart Soft Capsule 0.5mg to AD-208', 'description': 'Period 1: Avodart Soft Capsule 0.5mg, 1 Capsule Period 2: AD-208, 1 tab', 'interventionNames': ['Drug: AD-208', 'Drug: Avodart Soft Capsule 0.5mg']}, {'type': 'EXPERIMENTAL', 'label': 'AD-208 to Avodart Soft Capsule 0.5mg', 'description': 'Period 1: AD-208, 1 tab Period 2: Avodart Soft Capsule 0.5mg, 1 Capsule', 'interventionNames': ['Drug: AD-208', 'Drug: Avodart Soft Capsule 0.5mg']}], 'interventions': [{'name': 'AD-208', 'type': 'DRUG', 'description': 'Dutasteride 0.2mg', 'armGroupLabels': ['AD-208 to Avodart Soft Capsule 0.5mg', 'Avodart Soft Capsule 0.5mg to AD-208']}, {'name': 'Avodart Soft Capsule 0.5mg', 'type': 'DRUG', 'description': 'Dutasteride 0.5mg', 'armGroupLabels': ['AD-208 to Avodart Soft Capsule 0.5mg', 'Avodart Soft Capsule 0.5mg to AD-208']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Young-Ran Yoon, M.D., Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kyungpook National University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Addpharma Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}