Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2026-01-06 @ 12:09 PM
Study NCT ID:
NCT02402595
Status:
COMPLETED
Last Update Posted:
2017-03-20
First Post:
2015-02-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C507057', 'term': 'dextromethorphan - quinidine combination'}, {'id': 'D017964', 'term': 'Itraconazole'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010879', 'term': 'Piperazines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-16', 'studyFirstSubmitDate': '2015-02-26', 'studyFirstSubmitQcDate': '2015-03-27', 'lastUpdatePostDateStruct': {'date': '2017-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in plasma concentration of AVP-923 after dosing in combination with itraconazole', 'timeFrame': '16 Days'}, {'measure': 'Change in plasma concentration of AVP-786 after dosing in combination with itraconazole', 'timeFrame': '16 Days'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) for AVP-923 and itraconazole', 'timeFrame': '16 Days'}, {'measure': 'Incidence of adverse events (AEs) for AVP-786 and itraconazole', 'timeFrame': '16 Days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Drug-drug interaction', 'Healthy Volunteers', 'Pharmacokinetics', 'deuterated dextromethorphan', 'dextromethorphan', 'dextromethorphan with quinidine', 'deuterated dextromethorphan with quinidine', 'itraconazole'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.', 'detailedDescription': 'A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males and females, 18 to 55 years of age\n* Body Mass Index (BMI) ≥19 and ≤30 kg/m2 (for both males and females)\n\nExclusion Criteria:\n\n* History or presence of significant disease\n* History of substance abuse or dependence (except caffeine), or treatment for substance use disorder(s) within the year prior to screening or within 6 months for nicotine including e-cigarettes\n* Use of any tobacco-containing or nicotine-containing products within 6 months prior to the first dose\n* Use of any prescription or the over-the-counter medications within 14 days'}, 'identificationModule': {'nctId': 'NCT02402595', 'acronym': 'DDI', 'briefTitle': 'Drug Interaction Study Between AVP-923 and Itraconazole and Between AVP-786 and Itraconazole in Healthy Adult Subejcts', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avanir Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Single-center, Randomized, Double-blind, Double-dummy, Drug Interaction Study Between AVP-923 and Itraconazole, and Between AVP-786 and Itraconazole in Healthy Adult Subjects', 'orgStudyIdInfo': {'id': '15-AVP-786-103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence 1 - Period 1', 'description': 'AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15', 'interventionNames': ['Drug: AVP-923', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 1 - Period 2 (after 3-week washout)', 'description': 'AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15', 'interventionNames': ['Drug: AVP-786', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2 - Period 1', 'description': 'AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15', 'interventionNames': ['Drug: AVP-786', 'Drug: Itraconazole']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence 2 - Period 2 (after 3-week washout)', 'description': 'AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15', 'interventionNames': ['Drug: AVP-923', 'Drug: Itraconazole']}], 'interventions': [{'name': 'AVP-923', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1 - Period 1', 'Sequence 2 - Period 2 (after 3-week washout)']}, {'name': 'AVP-786', 'type': 'DRUG', 'armGroupLabels': ['Sequence 1 - Period 2 (after 3-week washout)', 'Sequence 2 - Period 1']}, {'name': 'Itraconazole', 'type': 'DRUG', 'otherNames': ['Sporanex'], 'armGroupLabels': ['Sequence 1 - Period 1', 'Sequence 1 - Period 2 (after 3-week washout)', 'Sequence 2 - Period 1', 'Sequence 2 - Period 2 (after 3-week washout)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Vince and Associates Clinical Research, Inc.', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Martin Kankam, MD, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vince and Associates Clinical Research Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avanir Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}