Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2025-12-28 @ 12:13 AM
Study NCT ID:
NCT05487404
Status:
COMPLETED
Last Update Posted:
2025-02-28
First Post:
2022-08-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-02-24', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C000716647', 'term': 'ADX-629'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bcavanagh@aldeyra.com', 'phone': '781-257-3063', 'title': 'Director of Clinical Trials', 'organization': 'Aldeyra Therapeutics, Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Two days for each intervention', 'eventGroups': [{'id': 'EG000', 'title': 'ADX-629', 'description': 'Three oral doses of ADX-629 600mg over two consecutive days', 'otherNumAtRisk': 23, 'deathsNumAtRisk': 23, 'otherNumAffected': 15, 'seriousNumAtRisk': 23, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Three oral doses of placebo over two consecutive days', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 21, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 20, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 14, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADX-629', 'description': 'Three oral doses of ADX-629 600mg over two consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Three oral doses of placebo over two consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'The safety assessment period was approximately two days for each treatment period.', 'description': 'Safety was assessed through serious adverse event collection.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline of Dermal Flushing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADX-629', 'description': 'Three oral doses of ADX-629 600mg over two consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Three oral doses of placebo over two consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.02', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '1.37', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.', 'description': 'Dermal flushing was assessed on a 0 to 100 scale (0 = none, 100 = extremely severe). Change from baseline was analyzed using mixed model for repeated measures (MMRM), with baseline and emesis volume as covariates, and sequence, period, time point, and treatment as factors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}, {'type': 'SECONDARY', 'title': 'Change From Baseline for Romberg Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'ADX-629', 'description': 'Three oral doses of ADX-629 600mg over two consecutive days'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Three oral doses of placebo over two consecutive days'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.04', 'spread': '1.25', 'groupId': 'OG000'}, {'value': '-1.42', 'spread': '1.20', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.', 'description': 'Romberg Test was assessed for up to 60 seconds. Subjects stood with feet together and eyes closed, and the length of time the subject was able to stand without movement was recorded. Change from baseline was analyzed using MMRM, with baseline, number of bodyweight-standardized drinks consumed, and blood alcohol concentration as covariates, and sequence, period, time point, treatment, and the interaction of treatment by time point as factors.', 'unitOfMeasure': 'seconds', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ADX-629 First, Then Placebo', 'description': 'Subjects received three oral doses of ADX-629 600mg over two consecutive days, followed by a fourteen-day washout. Subjects then received three oral doses of placebo over two consecutive days.'}, {'id': 'FG001', 'title': 'Placebo First, Then ADX-629', 'description': 'Subjects received three oral doses of placebo over two consecutive days, followed by a fourteen-day washout. Subjects then received three oral doses of ADX-629 600mg over two consecutive days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'Twenty-six subjects were randomized in a crossover design. On Day 1 for each treatment period, subjects were dosed followed by ethanol consumption. Approximately three hours later, subjects were administered a second dose followed by continued ethanol consumption to reach a target blood alcohol concentration of 0.14 g/100mL, at which time assessments were conducted. On Day 2, subjects were dosed once and assessments were completed approximately two hours and five hours after dosing.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'ADX-629 First, Then Placebo', 'description': 'Subjects received three oral doses of ADX-629 600mg over two consecutive days, followed by a fourteen-day washout. Subjects then received three oral doses of placebo over two consecutive days.'}, {'id': 'BG001', 'title': 'Placebo First, Then ADX-629', 'description': 'Subjects received three oral doses of placebo over two consecutive days, followed by a fourteen-day washout. Subjects then received three oral doses of ADX-629 600mg over two consecutive days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.1', 'spread': '9.0', 'groupId': 'BG000'}, {'value': '41.1', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '42.5', 'spread': '10.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '26.4', 'spread': '3.0', 'groupId': 'BG000'}, {'value': '26.6', 'spread': '3.5', 'groupId': 'BG001'}, {'value': '26.5', 'spread': '3.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-03-16', 'size': 360727, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-01-13T16:59', 'hasProtocol': True}, {'date': '2022-05-19', 'size': 800475, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-01-13T17:17', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-24', 'studyFirstSubmitDate': '2022-08-02', 'resultsFirstSubmitDate': '2025-02-05', 'studyFirstSubmitQcDate': '2022-08-02', 'lastUpdatePostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-02-24', 'studyFirstPostDateStruct': {'date': '2022-08-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Serious Adverse Events', 'timeFrame': 'The safety assessment period was approximately two days for each treatment period.', 'description': 'Safety was assessed through serious adverse event collection.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline of Dermal Flushing', 'timeFrame': 'The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.', 'description': 'Dermal flushing was assessed on a 0 to 100 scale (0 = none, 100 = extremely severe). Change from baseline was analyzed using mixed model for repeated measures (MMRM), with baseline and emesis volume as covariates, and sequence, period, time point, and treatment as factors.'}, {'measure': 'Change From Baseline for Romberg Test', 'timeFrame': 'The efficacy assessment period was approximately two days for each treatment period. Baseline was the last measurement prior to each treatment period.', 'description': 'Romberg Test was assessed for up to 60 seconds. Subjects stood with feet together and eyes closed, and the length of time the subject was able to stand without movement was recorded. Change from baseline was analyzed using MMRM, with baseline, number of bodyweight-standardized drinks consumed, and blood alcohol concentration as covariates, and sequence, period, time point, treatment, and the interaction of treatment by time point as factors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aldeyra', 'ADX-629'], 'conditions': ['Ethanol Intoxication']}, 'descriptionModule': {'briefSummary': 'A Double-Blind Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female subjects between the ages of 21 and 65 years, inclusive, at Screening;\n2. Subjects with the ability to obtain transportation to and from the study site;\n3. Subjects who agree to abstain from consumption of non-study alcohol during the study.\n\nExclusion Criteria:\n\n1. Subjects with abnormal laboratory values of clinical significance, at the discretion of the Investigator, at Screening;\n2. Subjects with nicotine product use within 14 days prior to Screening until the end of the study;\n3. Subjects with any history of or current alcohol or other substance use disorder diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition;\n4. Subjects with a positive urine drug screen or breath alcohol test at Screening or Check-In (both treatment periods).'}, 'identificationModule': {'nctId': 'NCT05487404', 'briefTitle': 'A Clinical Trial to Evaluate the Safety and Efficacy of ADX-629 in in Subjects With Elevated Ethanol Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Aldeyra Therapeutics, Inc.'}, 'officialTitle': 'A Double-Blind Clinical Trial to Assess the Interaction Between ADX-629 and Ethanol While Exploring the Safety, Tolerability, and Activity of ADX-629 in Subjects With Elevated Ethanol Levels', 'orgStudyIdInfo': {'id': 'ADX-629-ET-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADX-629 Oral Tablets', 'interventionNames': ['Drug: ADX-629']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'ADX-629', 'type': 'DRUG', 'description': '3 oral doses of ADX-629 600 milligrams', 'armGroupLabels': ['ADX-629 Oral Tablets']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3 oral doses of placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '45230', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Medpace Clinical Pharmacology', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aldeyra Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}