Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 4:03 PM
Study NCT ID:
NCT01452906
Status:
COMPLETED
Last Update Posted:
2011-12-12
First Post:
2011-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Drug-Drug Interaction Study of Omeprazole and PA21
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D009853', 'term': 'Omeprazole'}, {'id': 'D005502', 'term': 'Food'}], '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': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-12-08', 'studyFirstSubmitDate': '2011-09-22', 'studyFirstSubmitQcDate': '2011-10-12', 'lastUpdatePostDateStruct': {'date': '2011-12-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Curve from time zero to 24 hours (AUC0-24)', 'timeFrame': 'pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24 hours post omeprazole dose on Days 0, 11, 22', 'description': 'Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours'}, {'measure': 'Area Under the Curve from time zero to infinite (AUC0-infinity)', 'timeFrame': 'pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22', 'description': 'Area under the plasma concentration versus time curve from time zero (pre-dose) to extrapolated infinite time'}, {'measure': 'Maximum observed plasma concentration (Cmax)', 'timeFrame': 'pre-dose, 0.25, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 12, 24, 48 hours post omeprazole dose on days 0, 11, 22'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug-drug interaction', 'Pharmacokinetics', 'PA21', 'Drug Interaction Potentiation'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if Omeprazole is affected by PA21.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy Volunteers\n* Written informed consent\n\nExclusion Criteria:\n\n* No significant medical conditions\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01452906', 'briefTitle': 'A Drug-Drug Interaction Study of Omeprazole and PA21', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vifor Pharma'}, 'officialTitle': 'A Single-centre, Open-label, Three-period Study of the Pharmacokinetic Effect of PA21 on Omeprazole in Healthy Male and Female Adults', 'orgStudyIdInfo': {'id': 'PA-DDI-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PA21 and Omeprazole with food', 'interventionNames': ['Drug: PA21 and Omeprazole with food']}, {'type': 'EXPERIMENTAL', 'label': 'No PA21; Omeprazole with food', 'interventionNames': ['Drug: No PA21; Omeprazole with food']}, {'type': 'EXPERIMENTAL', 'label': 'PA21 with food, Omeprazole 2 hrs later', 'interventionNames': ['Drug: PA21 with food, Omeprazole 2hrs later']}], 'interventions': [{'name': 'PA21 and Omeprazole with food', 'type': 'DRUG', 'description': 'The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day', 'armGroupLabels': ['PA21 and Omeprazole with food']}, {'name': 'No PA21; Omeprazole with food', 'type': 'DRUG', 'description': 'The maximum dosage of Omeprazole will be 40 mg/day', 'armGroupLabels': ['No PA21; Omeprazole with food']}, {'name': 'PA21 with food, Omeprazole 2hrs later', 'type': 'DRUG', 'description': 'The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day', 'armGroupLabels': ['PA21 with food, Omeprazole 2 hrs later']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'ACRI - Phase 1', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}], 'overallOfficials': [{'name': 'Peter J Winkle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ACRI - Phase 1 (Advanced Clinical Research Institute)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vifor Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}