Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-24 @ 5:04 PM
Study NCT ID:
NCT02174835
Status:
COMPLETED
Last Update Posted:
2014-06-26
First Post:
2014-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C507057', 'term': 'dextromethorphan - quinidine combination'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-24', 'studyFirstSubmitDate': '2014-06-23', 'studyFirstSubmitQcDate': '2014-06-24', 'lastUpdatePostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma concentrations of AVP-786', 'timeFrame': '7 days'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events (AEs) for AVP-786', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pharmacokinetics', 'Healthy Volunteers', 'deuterated dextromethorphan', 'deuterated dextromethorphan with quinidine'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To assess the multiple-dose pharmacokinetics (PK), safety and tolerability of AVP-786 (deuterated \\[d6\\] dextromethorphan hydrobromide \\[DM\\]/quinidine sulfate \\[Q\\]) in healthy volunteers.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult males\n* 18 - 45 years of age\n* BMI 18 - 30 kg/m2\n\nExclusion Criteria:\n\n* History or presence of significant disease\n* History of substance abuse and/or alcohol abuse with the past 3 years\n* Use of tobacco-containing or nicotine-containing products within 6 months\n* Use of any prescription or the over-the-counter medications within 14 days'}, 'identificationModule': {'nctId': 'NCT02174835', 'briefTitle': 'A Phase-1 Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avanir Pharmaceuticals'}, 'officialTitle': 'A Phase 1, Single-center, Randomized, Open-label Study to Assess the Pharmacokinetics, Safety and Tolerability of AVP-786 (Deuterated [d6] Dextromethorphan Hydrobromide/Quinidine Sulfate) in Healthy Volunteers', 'orgStudyIdInfo': {'id': '13-AVR-134'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A - Period 1', 'description': 'Twice daily dosing orally for 7 days', 'interventionNames': ['Drug: AVP-786']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort A - Period 2', 'description': 'Twice daily dosing orally for 7 days', 'interventionNames': ['Drug: AVP-923']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A - Period 3', 'description': 'Twice daily dosing orally for 7 days', 'interventionNames': ['Drug: AVP-786']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B - Period 1', 'description': 'Twice daily dosing orally for 7 days', 'interventionNames': ['Drug: AVP-786']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cohort B - Period 2', 'description': 'Twice daily dosing orally for 7 days', 'interventionNames': ['Drug: AVP-923']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B - Period 3', 'description': 'Twice daily dosing orally for 7 days', 'interventionNames': ['Drug: AVP-786']}], 'interventions': [{'name': 'AVP-786', 'type': 'DRUG', 'armGroupLabels': ['Cohort A - Period 1', 'Cohort A - Period 3', 'Cohort B - Period 1', 'Cohort B - Period 3']}, {'name': 'AVP-923', 'type': 'DRUG', 'armGroupLabels': ['Cohort A - Period 2', 'Cohort B - Period 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Adelaide', 'state': 'South Australia', 'country': 'Australia', 'facility': 'CMAX', 'geoPoint': {'lat': -34.92866, 'lon': 138.59863}}], 'overallOfficials': [{'name': 'Sepehr Shakib, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CMAX'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avanir Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}