Ignite Creation Date:
2025-12-24 @ 4:51 PM
Ignite Modification Date:
2026-04-05 @ 12:17 PM
Study NCT ID:
NCT00489450
Status:
COMPLETED
Last Update Posted:
2007-06-21
First Post:
2007-06-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Study to Investigate the Alcohol Interaction of SK3530
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007172', 'term': 'Erectile Dysfunction'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C518762', 'term': '2-(5-(4-(2-hydroxyethyl)piperazin-1-ylsulfonyl)-2-n-propoxyphenyl)-5-ethyl-7-n-propyl-3,5-dihydro-4H-pyrrolo(3,2-d)pyrimidin-4-one dihydrochloride'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-03', 'completionDateStruct': {'date': '2007-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-06-20', 'studyFirstSubmitDate': '2007-06-20', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PK parameters - AUC, Cmax', 'timeFrame': '24hr after administration'}], 'secondaryOutcomes': [{'measure': 'Safety (Vital signs, Adverse events)', 'timeFrame': 'until post-study visit'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['SK3530', 'alcohol', 'pharmacokinetics', 'safety'], 'conditions': ['Erectile Dysfunction']}, 'descriptionModule': {'briefSummary': 'This study was designed to investigate the alcohol effect of SK3530 on the pharmacokinetics (PKs) and safety.', 'detailedDescription': 'This study was a randomized, open, single-dose, three-treatment, three-period, three-sequence, crossover study in which subjects were received, in random order, SK3530 100mg alone, 0.5g/Kg of alcohol alone, and SK3530 plus alcohol together. There was a minimum of a 7 day washout period between treatments. The alcohol was diluted to 240 mL with water. The contents were drunk in 1 minutes or less. For SK3530 and metabolite measurement, plasma samples were collected at pre-scheduled time and the safety was monitored all through the study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ages 20 to 50\n* body weight of IBM ± 20%\n\nExclusion Criteria:\n\n* cardiovascular disease\n* color-blindness or weakness\n* no availability to intake 0.5 g/Kg alcohol\n* abnormal supine blood preesure'}, 'identificationModule': {'nctId': 'NCT00489450', 'briefTitle': 'Phase I Study to Investigate the Alcohol Interaction of SK3530', 'organization': {'class': 'INDUSTRY', 'fullName': 'SK Chemicals Co., Ltd.'}, 'officialTitle': 'Clinical Trial to Investigate the Influence of Alcohol on the Pharmacokinetics and Safety of SK3530 in Healthy Male Volunteers', 'orgStudyIdInfo': {'id': 'SK3530_AI_2006'}}, 'armsInterventionsModule': {'interventions': [{'name': 'SK3530', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'In-Jin Jang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SK Chemicals Co., Ltd.', 'class': 'INDUSTRY'}}}}