Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT02068105
Status:
COMPLETED
Last Update Posted:
2014-04-21
First Post:
2014-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 104}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-18', 'studyFirstSubmitDate': '2014-02-12', 'studyFirstSubmitQcDate': '2014-02-19', 'lastUpdatePostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative bioavailability of ALKS 5461 treatment groups', 'timeFrame': '21 days', 'description': 'The parameters for determining the bioavailability include Cmax, AUC last, and AUC(0-infinity).'}], 'secondaryOutcomes': [{'measure': 'Safety and tolerability: Incidence of adverse events', 'timeFrame': '21 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ALKS 5461', 'samidorphan'], 'conditions': ['Pharmacokinetics']}, 'descriptionModule': {'briefSummary': 'This is a study to test the safety of ALKS 5461 in healthy adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Be in good physical health\n* Body mass index of 18-30 kg/m2\n* Agree to use an approved method of birth control for the duration of the study\n* Additional criteria may apply\n\nExclusion Criteria:\n\n* Currently pregnant or breastfeeding\n* History of or current infection with Hepatitis B Virus, Hepatitis C Virus or Human Immunodeficiency Virus (HIV)\n* Current or history of any clinically significant medical or psychiatric condition\n* Current abuse or dependence on alcohol or any illicit drugs\n* Have used nicotine within 90 days\n* Have used St. John's Wort or consumed grapefruit, grapefruit juice, or juices containing grapefruit within 30 days\n* Have used any prescription or over-the-counter medication, including natural health products (with the exception of prescription birth control or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days\n* Have used opioids 30 days prior to screening or have an anticipated need for opioid medication at any point during the study\n* Have a history of intolerance or hypersensitivity to buprenorphine or opioid antagonists (eg, naltrexone, naloxone)\n* Additional criteria may apply"}, 'identificationModule': {'nctId': 'NCT02068105', 'briefTitle': 'A Study of ALKS 5461 in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Two-part Study to Evaluate the Relative Bioavailability of Two Formulations of ALKS 5461 and the Effect of Dose Titration of ALKS 5461 in Healthy Subjects', 'orgStudyIdInfo': {'id': 'ALK5461-209'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALKS 5461-A', 'interventionNames': ['Drug: ALKS 5461']}, {'type': 'EXPERIMENTAL', 'label': 'ALKS 5461-B', 'interventionNames': ['Drug: ALKS 5461']}, {'type': 'EXPERIMENTAL', 'label': 'ALKS 5461 Dose 1', 'interventionNames': ['Drug: ALKS 5461']}, {'type': 'EXPERIMENTAL', 'label': 'ALKS 5461 Dose 2', 'interventionNames': ['Drug: ALKS 5461']}, {'type': 'EXPERIMENTAL', 'label': 'ALKS 5461 Dose 3', 'interventionNames': ['Drug: ALKS 5461']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ALKS 5461', 'type': 'DRUG', 'description': 'Sublingual tablet', 'armGroupLabels': ['ALKS 5461 Dose 1', 'ALKS 5461 Dose 2', 'ALKS 5461 Dose 3', 'ALKS 5461-A', 'ALKS 5461-B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Sublingual tablet', 'armGroupLabels': ['Placebo']}]}, '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': 'Randall Marshall, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}