Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:01 AM
Study NCT ID:
NCT04828005
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2021-03-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacodynamic Evaluation of Intranasal Nalmefene
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C038981', 'term': 'nalmefene'}, {'id': 'D009270', 'term': 'Naloxone'}], 'ancestors': [{'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'PatientSafetyNA@Indivior.com', 'phone': '+1 804 379 1090', 'title': 'Clinical Director', 'organization': 'Opiant Pharmaceuticals'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Crossover study adverse event data collected form baseline through to day 6 with a +3 to 7 day follow-up. During the 6 day dosing they took either nalmefene or naloxone on day 1 followed by a 3 day washout and the other dose on day 5', 'description': 'Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; adverse events were not collected in Part 1 for Intranasal Nalmefene nor Intranasal Naloxone. Part 2 is reported.', 'eventGroups': [{'id': 'EG000', 'title': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray\n\nNalmefene hydrochloride: 3mg Nasal spray', 'otherNumAtRisk': 61, 'deathsNumAtRisk': 61, 'otherNumAffected': 56, 'seriousNumAtRisk': 61, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 52, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 25}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 35}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 13}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Dysgeusia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypercapnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperhidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot Flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 61, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 60, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray Naloxone hydrochloride: 4mg Nasal Spray'}, {'id': 'OG001', 'title': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray Nalmefene hydrochloride: 3mg Nasal spray'}], 'classes': [{'categories': [{'measurements': [{'value': '3.432', 'spread': '0.6117', 'groupId': 'OG000'}, {'value': '5.744', 'spread': '0.6240', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0009', 'groupIds': ['OG000'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY', 'nonInferiorityComment': 'Alternative hypothesis: Nalmefene reversal not less than 80% naloxone reversal'}], 'paramType': 'MEAN', 'timeFrame': '5 minutes', 'description': 'Change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Maximum Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '2.7', 'groupId': 'OG000'}, {'value': '5.8', 'spread': '3.0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to 2 hours', 'description': 'Maximum change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '60', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.04', 'upperLimit': '2.00'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.13', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Up to 2 hours', 'description': 'Time to maximum change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '56', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '2.71', 'spread': '0.59', 'groupId': 'OG000'}, {'value': '2.14', 'spread': '0.62', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '90 minutes', 'description': 'Change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '6.79', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '5.93', 'spread': '0.68', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '20 minutes', 'description': 'Change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '7.12', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '5.55', 'spread': '0.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '15 minutes', 'description': 'Change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '59', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '6.58', 'spread': '0.66', 'groupId': 'OG000'}, {'value': '4.96', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 minutes', 'description': 'Change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Minute Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '59', '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': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray\n\nNaloxone hydrochloride: 4mg Nasal Spray'}], 'classes': [{'categories': [{'measurements': [{'value': '2.55', 'spread': '0.38', 'groupId': 'OG000'}, {'value': '1.71', 'spread': '0.53', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2.5 minutes', 'description': 'Change in minute ventilation from opioid induced nadir', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1 Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone', 'description': 'Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).\n\nTreatment in Part 1\n\n* Healthy volunteers with prior opioid exposure received pretreatment with ondansetron (8 mg, oral) and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 5 minutes.\n* Subjects received 4 mg IN naloxone hydrochloride at Time 25 minutes.\n* Remifentanil infusion continued up to Time 115 minutes.'}, {'id': 'FG001', 'title': 'Part 1 Extension Setup (Ventilation Model): Remifentanil, Then Intranasal Naloxone', 'description': 'Subjects received First Treatment (1 Day) only. Treatment in Part 1 Extension.\n\n* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.\n* Subjects then received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.\n* IN naloxone hydrochloride was administered at Time 25 minutes.\n* Remifentanil infusion continued up to Time 146 minutes.'}, {'id': 'FG002', 'title': 'Part 2: Intranasal Nalmefene Crossover to Intranasal Naloxone', 'description': 'Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.\n\nSubjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).\n\nTreatment in Part 2\n\n* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.\n* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.\n* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.\n* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.\n* Remifentanil infusion continued up to Time 146 minutes.'}, {'id': 'FG003', 'title': 'Part 2: Intranasal Naloxone Crossover to Intranasal Nalmefene', 'description': 'Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.\n\nSubjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).\n\nTreatment in Part 2\n\n* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.\n* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.\n* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.\n* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.\n* Remifentanil infusion continued up to Time 146 minutes.'}], 'periods': [{'title': 'Part 1 Setup: 1st Treatment (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 1 Setup: Washout (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 1 Setup: 2nd Treatment (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 1 Extension: 1st Treatment (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'In the Part 1 Extension, there was no Washout or 2nd Treatment.', 'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'In the Part 1 Extension, there was no Washout or 2nd Treatment.', 'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Part 2: 1st Treatment (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '34'}, {'groupId': 'FG003', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Equipment failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}, {'title': 'Part 2: Washout (4 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}]}, {'title': 'Part 2: 2nd Treatment (1 Day)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '30'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '25'}, {'groupId': 'FG003', 'numSubjects': '27'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Part 1 Setup and Part 1 Extension Setup were Ventilation Models only; outcome measures were not collected in Part 1. Part 2 participant flow was only reported as one group (i.e., it is not possible to show how many participants received each intervention).'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Part 1: Intranasal Nalmefene', 'description': 'Subjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).\n\nTreatment in Part 1\n\n* Healthy volunteers with prior opioid exposure received pretreatment with ondansetron (8 mg, oral) and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 5 minutes.\n* Subjects received 4 mg IN naloxone hydrochloride at Time 25 minutes.\n* Remifentanil infusion continued up to Time 115 minutes.'}, {'id': 'BG001', 'title': 'Part 1 Extension: Intranasal Nalmefene', 'description': 'Subjects received First Treatment (1 Day) only. Treatment in Part 1 Extension.\n\n* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.\n* Subjects then received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* Subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.\n* IN naloxone hydrochloride was administered at Time 25 minutes.\n* Remifentanil infusion continued up to Time 146 minutes.'}, {'id': 'BG002', 'title': 'Part 2: Intranasal Nalmefene Compared to Intranasal Naloxone', 'description': 'Part 2 was a randomized, 2-treatment crossover study to compare Intranasal Nalmefene to Intranasal Naloxone.\n\nSubjects received First Treatment (1 Day), followed by Washout (4 Days), followed by Second Treatment (1 Day).\n\nTreatment in Part 2\n\n* Healthy volunteers with prior opioid exposure received a naloxone challenge test on the day of clinical admission to ensure the subject was not physically dependent on opioids.\n* After the naloxone challenge test, eligibility review and completion of admission procedures, each subject was randomized to receive either IN nalmefene hydrochloride or IN naloxone hydrochloride in a 2-period crossover manner, with a 4-day washout period between doses.\n* All subjects received pretreatment with famotidine (20 mg IV), ondansetron (8 mg, oral), and sodium citrate (30 mL, oral) 30 minutes to 1 hour prior to remifentanil infusion.\n* All subjects started receiving a hypercapnic gas mixture (50% O2, 43% N2, 7% CO2) using a ventilatory response to hypercapnia (VRH) face mask at Time 0 minutes, followed by a remifentanil hydrochloride infusion at Time 10 minutes.\n* In accordance with the randomization schedule, IN nalmefene hydrochloride (3 mg) or IN naloxone hydrochloride (4 mg) was administered at Time 25 minutes.\n* Remifentanil infusion continued up to Time 146 minutes.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '28.6', 'spread': '4.50', 'groupId': 'BG000'}, {'value': '29.1', 'spread': '11.05', 'groupId': 'BG001'}, {'value': '29.1', 'spread': '7.79', 'groupId': 'BG002'}, {'value': '29.1', 'spread': '7.84', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '60', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '69', 'groupId': 'BG003'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}, {'title': 'Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '25.03', 'spread': '3.338', 'groupId': 'BG000'}, {'value': '24.48', 'spread': '3.665', 'groupId': 'BG001'}, {'value': '25.27', 'spread': '3.316', 'groupId': 'BG002'}, {'value': '25.17', 'spread': '3.317', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '79.13', 'spread': '16.616', 'groupId': 'BG000'}, {'value': '78.65', 'spread': '9.735', 'groupId': 'BG001'}, {'value': '78.30', 'spread': '14.120', 'groupId': 'BG002'}, {'value': '78.40', 'spread': '13.833', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '178.7', 'spread': '9.71', 'groupId': 'BG000'}, {'value': '179.8', 'spread': '9.38', 'groupId': 'BG001'}, {'value': '175.6', 'spread': '10.21', 'groupId': 'BG002'}, {'value': '176.3', 'spread': '10.08', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-07', 'size': 1007884, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-05-19T06:26', 'hasProtocol': True}, {'date': '2022-04-12', 'size': 2962642, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-05-19T06:27', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 84}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-24', 'studyFirstSubmitDate': '2021-03-30', 'resultsFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-24', 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Minute Ventilation', 'timeFrame': '5 minutes', 'description': 'Change in minute ventilation from opioid induced nadir'}], 'secondaryOutcomes': [{'measure': 'Maximum Change in Minute Ventilation', 'timeFrame': 'Up to 2 hours', 'description': 'Maximum change in minute ventilation from opioid induced nadir'}, {'measure': 'Time to Maximum Change in Minute Ventilation', 'timeFrame': 'Up to 2 hours', 'description': 'Time to maximum change in minute ventilation from opioid induced nadir'}, {'measure': 'Change in Minute Ventilation', 'timeFrame': '90 minutes', 'description': 'Change in minute ventilation from opioid induced nadir'}, {'measure': 'Change in Minute Ventilation', 'timeFrame': '20 minutes', 'description': 'Change in minute ventilation from opioid induced nadir'}, {'measure': 'Change in Minute Ventilation', 'timeFrame': '15 minutes', 'description': 'Change in minute ventilation from opioid induced nadir'}, {'measure': 'Change in Minute Ventilation', 'timeFrame': '10 minutes', 'description': 'Change in minute ventilation from opioid induced nadir'}, {'measure': 'Change in Minute Ventilation', 'timeFrame': '2.5 minutes', 'description': 'Change in minute ventilation from opioid induced nadir'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pharmacodynamic']}, 'descriptionModule': {'briefSummary': 'This study is to determine the pharmacodynamics (the effects of the drug and mechanisms of their action within the body) of Nalmefene when given intranasally (IN; into the nose) compared to intranasal naloxone when given to healthy volunteers under steady state opioid agonism.', 'detailedDescription': 'Open-label, 2-part study. Part 1 is a pilot study to determine the relationship between opioid agonism and suppression of carbon dioxide induced increases in minute ventilation prior to opioid exposure. Part 2 will be a randomized, 2 period, 2 treatment, crossover study to evaluate the pharmacodynamic effects of intranasal (IN) nalmefene compared to IN naloxone to reverse opioid-induced suppression of carbon dioxide induced increases in minute ventilation, in healthy volunteers with prior opioid exposure.\n\nBoth Part 1 and Part 2 of the study will consist of an outpatient Screening Visit taking place 28 days prior to admission, an in-clinic Treatment Phase consisting of a 6 or 7 day inpatient stay, and a Follow-Up Phone Call conducted 3 to 7 days after 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 32 kg/m2, inclusive\n* Adequate venous access\n* Healthy subjects and non-dependent who are non dependent opioid experienced users, opioid experience defined as exposure to an opioid on at least 1 occasion prior to screening\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* Subject who has a difficult airway for intubation.\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 or naloxone or known hypersensitivity reaction to plastics.'}, 'identificationModule': {'nctId': 'NCT04828005', 'briefTitle': 'Pharmacodynamic Evaluation of Intranasal Nalmefene', 'organization': {'class': 'INDUSTRY', 'fullName': 'Opiant Pharmaceuticals Inc'}, 'officialTitle': 'A Two-part Open Label Study of the Pharmacodynamic Effects of Intranasal Nalmefene Compared to Intranasal Naloxone in Healthy Volunteers Under Steady State Opioid Agonism', 'orgStudyIdInfo': {'id': 'OPNT003-PD-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intranasal Nalmefene', 'description': 'Nalmefene hydrochloride nasal spray, 3mg, 1 spray', 'interventionNames': ['Drug: Nalmefene hydrochloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intranasal Naloxone', 'description': 'Naloxone hydrochloride nasal spray, 4mg, 1 spray', 'interventionNames': ['Drug: Naloxone hydrochloride']}], 'interventions': [{'name': 'Nalmefene hydrochloride', 'type': 'DRUG', 'description': '3mg Nasal spray', 'armGroupLabels': ['Intranasal Nalmefene']}, {'name': 'Naloxone hydrochloride', 'type': 'DRUG', 'description': '4mg Nasal Spray', 'armGroupLabels': ['Intranasal Naloxone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Shawn Searle, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PRA Health Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Opiant Pharmaceuticals Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}