Ignite Creation Date:
2025-12-24 @ 5:42 PM
Ignite Modification Date:
2026-01-09 @ 8:43 PM
Study NCT ID:
NCT04759768
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2021-02-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic Evaluation of Intranasal Nalmefene
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C038981', 'term': 'nalmefene'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PatientSafetyNA@Indivior.com', 'phone': '18043791090', 'title': 'Clinical Director', 'organization': 'Opiant Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Subjects in the study from baseline to 7 days with a =3 to 5 day follow-up', 'eventGroups': [{'id': 'EG000', 'title': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray\n\nNalmefene Hydrochloride: 3mg nasal spray', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 42, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intramuscular Nalmefene', 'description': 'Nalmefene injection, 1mg, 1 injection\n\nNalmefene: 1mg intramuscular injection', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 8, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 68, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray\n\nNalmefene Hydrochloride: 3mg nasal spray'}, {'id': 'OG001', 'title': 'Intramuscular Nalmefene', 'description': 'Nalmefene injection, 1mg, 1 injection\n\nNalmefene: 1mg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '6.71', 'groupId': 'OG000'}, {'value': '1.77', 'spread': '1.18', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Maximum concentration of plasma nalmefene comparing IN to IM', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time to Maximum Plasma Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray\n\nNalmefene Hydrochloride: 3mg nasal spray'}, {'id': 'OG001', 'title': 'Intramuscular Nalmefene', 'description': 'Nalmefene injection, 1mg, 1 injection\n\nNalmefene: 1mg intramuscular injection'}], 'classes': [{'categories': [{'measurements': [{'value': '0.25', 'groupId': 'OG000', 'lowerLimit': '0.0833', 'upperLimit': '2'}, {'value': '0.333', 'groupId': 'OG001', 'lowerLimit': '0.117', 'upperLimit': '18'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '48 hours', 'description': 'Time to maximum concentration of plasma nalmefene comparing IN to IM', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC-inf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Nalmefene', 'description': '3 mg nalmefene hydrochloride intranasally (1 spray)'}, {'id': 'OG001', 'title': 'Intramuscular Nalmefene', 'description': '1 mg nalmefene hydrochloride solution intramuscularly (single dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '41.5', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '17.0', 'spread': '3.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Area under the curve of plasma nalmefene comparing IN to IM', 'unitOfMeasure': 'hour*ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Nalmefene', 'description': '3 mg nalmefene hydrochloride intranasally (1 spray)'}, {'id': 'OG001', 'title': 'Intramuscular Nalmefene', 'description': '1 mg nalmefene hydrochloride solution intramuscularly (single dose)'}], 'classes': [{'categories': [{'measurements': [{'value': '11.4', 'spread': '2.37', 'groupId': 'OG000'}, {'value': '10.6', 'spread': '1.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '48 hours', 'description': 'Half life of plasma nalmefene comparing IN to IM', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intranasal Nalmefene Then Intramuscular Nalmefene', 'description': '3 mg nalmefene hydrochloride intranasally (1 spray) then 1 mg nalmefene hydrochloride solution intramuscularly (single dose)'}, {'id': 'FG001', 'title': 'Intramuscular Nalmefene Then Intranasal Nalmefene', 'description': '1 mg nalmefene hydrochloride solution intramuscularly (single dose) then 3 mg nalmefene hydrochloride intranasally (1 spray)'}], 'periods': [{'title': 'First Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout (7 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Second Intervention (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Complete'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intranasal Nalmefene Then Intramuscular Nalmefene', 'description': '3 mg nalmefene hydrochloride intranasally (1 spray) then 1 mg nalmefene hydrochloride solution intramuscularly (single dose)'}, {'id': 'BG001', 'title': 'Intramuscular Nalmefene Then Intranasal Nalmefene', 'description': '1 mg nalmefene hydrochloride solution intramuscularly (single dose) then 3 mg nalmefene hydrochloride intranasally (1 spray)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Age 18 to 55 years old', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or other specific islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '41', 'groupId': 'BG002'}]}]}, {'title': 'Multiple', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '68', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '26.58', 'spread': '2.540', 'groupId': 'BG000'}, {'value': '25.60', 'spread': '2.996', 'groupId': 'BG001'}, {'value': '26.09', 'spread': '2.800', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-11-11', 'size': 230392, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-19T06:56', 'hasProtocol': True}, {'date': '2021-02-09', 'size': 742898, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-19T06:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2021-02-15', 'resultsFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2021-02-15', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-08-12', 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': '48 hours', 'description': 'Maximum concentration of plasma nalmefene comparing IN to IM'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax)', 'timeFrame': '48 hours', 'description': 'Time to maximum concentration of plasma nalmefene comparing IN to IM'}, {'measure': 'Area Under the Curve (AUC-inf)', 'timeFrame': '48 hours', 'description': 'Area under the curve of plasma nalmefene comparing IN to IM'}, {'measure': 'Half-life (t1/2)', 'timeFrame': '48 hours', 'description': 'Half life of plasma nalmefene comparing IN to IM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacokinetics']}, 'referencesModule': {'references': [{'pmid': '37496452', 'type': 'DERIVED', 'citation': 'Crystal R, Ellison M, Purdon C, Skolnick P. Pharmacokinetic Properties of an FDA-approved Intranasal Nalmefene Formulation for the Treatment of Opioid Overdose. Clin Pharmacol Drug Dev. 2024 Jan;13(1):58-69. doi: 10.1002/cpdd.1312. Epub 2023 Jul 27.'}]}, 'descriptionModule': {'briefSummary': 'This study is to determine the pharmacokinetics (how the body absorbs, breaks down and eliminates drug from your body) of nalmefene when given intranasally (IN;into the nose) compared to a dose of nalmefene when given intramuscularly (IM; into the muscle); to compare the blood levels of nalmefene when given IN to nalmefene when given IM; and to evaluate the safety and tolerability of nalmefene IN.', 'detailedDescription': 'Open-label, randomized, 2-period, 2-treatment, 2-sequence, crossover study in 68 healthy volunteers. Subjects will be assigned to each of the 2 possible sequences. Each subject will receive 2 treatments during the 2 dosing periods: Intranasal (IN) dose of 3 mg nalmefene hydrochloride and intramuscular (IM) dose of 1.0 mg nalmefene, with a 4 day washout period between doses. Screening can occur up to 28 days before baseline admission, subjects will then stay in the inpatient facility for 7 days to complete the treatment phase of the study and will be discharged following completion of the discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning Adverse Events (AEs) and concomitant medications since discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 to 55 years inclusive\n* BMI ranging from 18 to 30 kg/m2, inclusive\n* Adequate venous access\n* Subjects must be non-smokers\n\nExclusion Criteria:\n\n* History of clinically significant disease\n* Significant trauma injury, major surgery, open biopsy within 30 days prior to screening\n* Following an abnormal diet 4 weeks prior to screening\n* Use of over the counter medications, dietary supplements, herbal products, vitamins or opioid analgesics 14 days before intervention\n* Use of enzyme altering drugs 30 days before intervention\n* Use of nasal products 28 days before intervention and throughout the study\n* Previous or current opioid, alcohol, or other drug dependence\n* Donated or received blood 30 days before intervention\n* Women who are pregnant or breastfeeding at screening\n* Women of childbearing potential unless surgically sterile or use effective contraception\n* Current or recent upper respiratory tract infection\n* Allergic to nalmefene'}, 'identificationModule': {'nctId': 'NCT04759768', 'briefTitle': 'Pharmacokinetic Evaluation of Intranasal Nalmefene', 'organization': {'class': 'INDUSTRY', 'fullName': 'Opiant Pharmaceuticals Inc'}, 'officialTitle': 'Two-Period, Two-Treatment, Randomized Crossover Study of the Pharmacokinetics of Nalmefene by Intranasal and Intramuscular Administration in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'OPNT003-PK-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray', 'interventionNames': ['Drug: Nalmefene Hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intramuscular Nalmefene', 'description': 'Nalmefene injection, 1mg, 1 injection', 'interventionNames': ['Drug: Nalmefene']}], 'interventions': [{'name': 'Nalmefene Hydrochloride', 'type': 'DRUG', 'description': '3mg nasal spray', 'armGroupLabels': ['Intranasal Nalmefene']}, {'name': 'Nalmefene', 'type': 'DRUG', 'description': '1mg intramuscular injection', 'armGroupLabels': ['Intramuscular Nalmefene']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78217', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Worldwide Clinical Trials', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Robert Bass, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Worldwide Clinical Trials'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Opiant Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}