Ignite Creation Date:
2025-12-26 @ 11:00 AM
Ignite Modification Date:
2026-01-13 @ 11:08 AM
Study NCT ID:
NCT02508506
Status:
COMPLETED
Last Update Posted:
2016-02-04
First Post:
2015-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051437', 'term': 'Renal Insufficiency'}], 'ancestors': [{'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, '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': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-03', 'studyFirstSubmitDate': '2015-07-23', 'studyFirstSubmitQcDate': '2015-07-23', 'lastUpdatePostDateStruct': {'date': '2016-02-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area under the plasma concentration versus time curve from time 0 to infinity (AUC0-inf) following a single dose of ALKS 5461', 'timeFrame': 'up to 168 hours postdose'}, {'measure': 'Area under the plasma concentration versus time curve from time 0 to time of last measurable concentration (AUC0-last) following a single dose of ALKS 5461', 'timeFrame': 'up to 168 hours postdose'}, {'measure': 'Maximum observed plasma concentration (CMAX) following a single dose of ALKS 5461', 'timeFrame': 'up to 168 hours postdose'}], 'secondaryOutcomes': [{'measure': 'Time to reach maximum plasma concentration (TMAX)', 'timeFrame': 'up to 168 hours postdose'}, {'measure': 'Terminal elimination half-life (T1/2)', 'timeFrame': 'up to 168 hours postdose'}, {'measure': 'Apparent clearance (CL/F)', 'timeFrame': 'up to 168 hours postdose'}, {'measure': 'Apparent volume of distribution (Vz/F)', 'timeFrame': 'up to 168 hours postdose'}, {'measure': 'Safety: Incidence of adverse events (SAE)', 'timeFrame': 'Up to 12 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ALKS 5461', 'Alkermes', 'Samidorphan', 'Renal Impairment', 'Pharmacokinetics', 'Buprenorphine'], 'conditions': ['Renal Impairment']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the effect of various degrees of renal function on the pharmacokinetics and safety of ALKS 5461.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor all subjects:\n\n* Has a body mass index (BMI) of 18.0-40.0 kg/m\\^2 and a total body weight \\>50kg\n* Agrees to use an approved method of contraception for the duration of the study\n* Additional criteria may apply\n\nFor subjects with renal impairment:\n\n* Has severe or end stage renal disease, and does not require dialysis\n* Has stable renal function for at least 60 days preceding screening\n* Additional criteria may apply\n\nExclusion Criteria:\n\nFor all subjects:\n\n* Has any past history or current finding of a clinically significant observed abnormality, psychiatric or medical condition other than renal impairment\n* Has a history of gastrointestinal surgery affecting drug absorption or biliary elimination, excluding appendectomy or cholecystectomy\n* Is pregnant, planning to become pregnant, or lactating\n* Has a history of clinically significant allergy or a hypersensitivity to opioids\n* Additional criteria my apply\n\nFor subjects with renal impairment:\n\n* Has evidence of compromised respiratory function, seizure disorder, or myasthenia gravis\n* Has received a kidney transplant\n* Additional criteria may apply'}, 'identificationModule': {'nctId': 'NCT02508506', 'briefTitle': 'Pharmacokinetics and Safety of ALKS 5461 in Subjects With Renal Impairment and Normal Renal Function', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkermes, Inc.'}, 'officialTitle': 'A Phase 1 Study of the Pharmacokinetics, Safety, and Tolerability of ALKS5461 in Subjects With Renal Impairment', 'orgStudyIdInfo': {'id': 'ALKS5461-A108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALKS 5461', 'description': 'Sublingual tablet', 'interventionNames': ['Drug: ALKS 5461']}], 'interventions': [{'name': 'ALKS 5461', 'type': 'DRUG', 'description': 'Single dose, given orally', 'armGroupLabels': ['ALKS 5461']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80228', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Alkermes Investigational SIte', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '32809', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Alkermes Investigational SIte', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '55404', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Alkermes Investigational Site', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'overallOfficials': [{'name': 'Arielle Stanford, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkermes, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkermes, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}