Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-25 @ 8:25 PM
Study NCT ID:
NCT01570569
Status:
COMPLETED
Last Update Posted:
2012-04-04
First Post:
2011-12-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D019808', 'term': 'Losartan'}, {'id': 'D003915', 'term': 'Dextromethorphan'}, {'id': 'D008874', 'term': 'Midazolam'}, {'id': 'D002110', 'term': 'Caffeine'}], 'ancestors': [{'id': 'D053799', 'term': '2-Pyridinylmethylsulfinylbenzimidazoles'}, {'id': 'D013454', 'term': 'Sulfoxides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001569', 'term': 'Benzodiazepines'}, {'id': 'D001552', 'term': 'Benzazepines'}, {'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-01', 'studyFirstSubmitDate': '2011-12-06', 'studyFirstSubmitQcDate': '2012-04-01', 'lastUpdatePostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax, AUC', 'timeFrame': '0, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12 hours post-dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Volunteers'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The investigators objectives were developing mini dose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.', 'detailedDescription': 'The investigators objectives were developing minidose five-drug cocktail regimen to evaluate potential drug-drug interactions associated with use of a cocktail of caffeine, losartan, omeprazole, dextromethorphan, and midazolam for simultaneous assessment of CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A activities.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy male subject whose CYP2C9, CYP2C19, CYP2D6 genotype was determined\n\nExclusion Criteria:\n\n* Subject who has abnormal laboratory test results'}, 'identificationModule': {'nctId': 'NCT01570569', 'briefTitle': 'Development of Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Development of High-throughput Minidose Inje Cocktail Method for Simultaneous Evaluating Five Cytochrome P450 Isoforms in Human', 'orgStudyIdInfo': {'id': '10-152'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omeprazole', 'interventionNames': ['Drug: Omeprazole', 'Drug: Cocktail']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Losartan', 'interventionNames': ['Drug: Losartan', 'Drug: Cocktail']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Dextromethorphan', 'interventionNames': ['Drug: Dextromethorphan', 'Drug: Cocktail']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Caffeine', 'interventionNames': ['Drug: Cocktail', 'Drug: Caffeine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Midazolam', 'interventionNames': ['Drug: Cocktail', 'Drug: Midazolam']}], 'interventions': [{'name': 'Omeprazole', 'type': 'DRUG', 'otherNames': ['The drug was made by Yuhan corp.', 'The drug was exclusively made for this study.'], 'description': 'Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.', 'armGroupLabels': ['Omeprazole']}, {'name': 'Losartan', 'type': 'DRUG', 'otherNames': ['The drug was made by Yuhan corp.', 'The drug was exclusively made for this study.'], 'description': 'Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.', 'armGroupLabels': ['Losartan']}, {'name': 'Dextromethorphan', 'type': 'DRUG', 'otherNames': ['The drug was made by Yuhan corp.', 'The drug was exclusively made for this study.'], 'description': 'Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.', 'armGroupLabels': ['Dextromethorphan']}, {'name': 'Cocktail', 'type': 'DRUG', 'otherNames': ['All of the drugs were made by Yuhan corp.', 'All of the drugs were exclusively made for this study.'], 'description': 'Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.\n\nGroup B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.', 'armGroupLabels': ['Caffeine', 'Dextromethorphan', 'Losartan', 'Midazolam', 'Omeprazole']}, {'name': 'Midazolam', 'type': 'DRUG', 'otherNames': ['The drug was made by Yuhan corp.', 'The drug was exclusively made for this study.'], 'description': 'Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.', 'armGroupLabels': ['Midazolam']}, {'name': 'Caffeine', 'type': 'DRUG', 'otherNames': ['The drug was made by Yuhan corp.', 'The drug was exclusively made for this study.'], 'description': 'Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.', 'armGroupLabels': ['Caffeine']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Jae Gook Shin, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inje University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Department of Pharmacology and Pharmacogenomics Research Center', 'investigatorFullName': 'Jae-Gook Shin', 'investigatorAffiliation': 'Inje University'}}}}