Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-04-06 @ 6:30 PM
Study NCT ID:
NCT02521857
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2015-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Water Consumption Study of ALKS 5461 in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000618349', 'term': 'ALKS 5461'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-09', 'studyFirstSubmitDate': '2015-08-11', 'studyFirstSubmitQcDate': '2015-08-11', 'lastUpdatePostDateStruct': {'date': '2015-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf', 'timeFrame': 'Up to 72 hours', 'description': 'Area under the plasma concentration-time curve from time 0 to infinity for ALKS 5461'}, {'measure': 'AUClast', 'timeFrame': 'Up to 72 hours', 'description': 'Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for ALKS 5461'}, {'measure': 'Cmax', 'timeFrame': 'Up to 72 hours', 'description': 'Maximum observed plasma concentration for ALKS 5461'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability will be measured by the incidence of Adverse Effects', 'timeFrame': 'Up to 46 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Alkermes', 'Samidorphan', 'ALKS 5461', 'Healthy Volunteer', 'Pharmacokinetics'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the impact of water consumption on the pharmacokinetics of ALKS 5461.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a body mass index (BMI) of 18.0 - 30.0 kg/m\\^2\n* Is in good physical health\n* Agrees to use an approved method of contraception for the duration of the study\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Is currently pregnant or breastfeeding\n* Has a history of substance abuse disorder\n* Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period\n* Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception of prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start\n* Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study\n* Has used alcohol within 72 hours prior to any inpatient period\n* Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)\n* Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02521857', 'briefTitle': 'A Water Consumption Study of ALKS 5461 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 1 Study to Evaluate the Impact of Water Consumption on the Pharmacokinetics of Sublingually Administered ALKS 5461', 'orgStudyIdInfo': {'id': 'ALK5461-A110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALKS 5461', 'description': 'Sublingual tablet', 'interventionNames': ['Drug: ALKS 5461']}], 'interventions': [{'name': 'ALKS 5461', 'type': 'DRUG', 'description': 'Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints', 'armGroupLabels': ['ALKS 5461']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66212', 'city': 'Overland Park', 'state': 'Kansas', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 38.98223, 'lon': -94.67079}}], 'overallOfficials': [{'name': 'Arielle Stanford, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}