{"protocolSection":{"identificationModule":{"nctId":"NCT02088697","orgStudyIdInfo":{"id":"031-13-003"},"organization":{"fullName":"Otsuka Pharmaceutical Co., Ltd.","class":"INDUSTRY"},"briefTitle":"A Bioequivalence Study of ASC-01 Placebo (Aripiprazole 0 mg/Sertraline 100 mg) and Sertraline Tablet in Healthy Male Subjects"},"statusModule":{"statusVerifiedDate":"2021-05","overallStatus":"COMPLETED","expandedAccessInfo":{"hasExpandedAccess":false},"startDateStruct":{"date":"2013-12"},"primaryCompletionDateStruct":{"date":"2014-01","type":"ACTUAL"},"completionDateStruct":{"date":"2014-01","type":"ACTUAL"},"studyFirstSubmitDate":"2014-03-12","studyFirstSubmitQcDate":"2014-03-13","studyFirstPostDateStruct":{"date":"2014-03-17","type":"ESTIMATED"},"resultsFirstSubmitDate":"2021-05-09","resultsFirstSubmitQcDate":"2021-05-09","resultsFirstPostDateStruct":{"date":"2021-06-03","type":"ACTUAL"},"lastUpdateSubmitDate":"2021-05-09","lastUpdatePostDateStruct":{"date":"2021-06-03","type":"ACTUAL"}},"sponsorCollaboratorsModule":{"responsibleParty":{"type":"SPONSOR"},"leadSponsor":{"name":"Otsuka Pharmaceutical Co., Ltd.","class":"INDUSTRY"}},"descriptionModule":{"briefSummary":"The purpose of this study is to investigate the bioequivalence of ASC-01 Placebo and sertraline Tablet in Japanese healthy male subjects."},"conditionsModule":{"conditions":["Healthy Volunteers"]},"designModule":{"studyType":"INTERVENTIONAL","phases":["PHASE1"],"designInfo":{"allocation":"RANDOMIZED","interventionModel":"PARALLEL","primaryPurpose":"TREATMENT","maskingInfo":{"masking":"NONE"}},"enrollmentInfo":{"count":50,"type":"ACTUAL"}},"armsInterventionsModule":{"armGroups":[{"label":"ASC-01 placebo","type":"EXPERIMENTAL","description":"A single oral dose of ASC-01 Placebo (sertraline 100 mg)","interventionNames":["Drug: Placebo"]},{"label":"Sertraline tablet","type":"ACTIVE_COMPARATOR","description":"A single oral dose of sertraline tablets (sertraline 100 mg)","interventionNames":["Drug: ASC-01"]}],"interventions":[{"type":"DRUG","name":"Placebo","armGroupLabels":["ASC-01 placebo"]},{"type":"DRUG","name":"ASC-01","armGroupLabels":["Sertraline tablet"]}]},"outcomesModule":{"primaryOutcomes":[{"measure":"Peak Plasma Concentration (Cmax) of Sertraline","timeFrame":"predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose"}],"secondaryOutcomes":[{"measure":"Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline","timeFrame":"predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose"}]},"eligibilityModule":{"eligibilityCriteria":"Inclusion Criteria:\n\n* Healthy male volunteers aged 20 to 40 years.\n* Have a body mass index (BMI) between 18.5 and 25.0 kg/m2 and a weight of at least 50 kg.\n\nExclusion Criteria:\n\n* History of any clinically important disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study.\n* History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically significant abnormalities in the physical examination, clinical laboratory values, 12-lead ECG, or vital signs, as judged by the Investigator.","healthyVolunteers":true,"sex":"MALE","minimumAge":"20 Years","maximumAge":"40 Years","stdAges":["ADULT"]},"contactsLocationsModule":{"locations":[{"facility":"Osaka Pharmacology Clinical research Hospital","city":"Osaka","country":"Japan","geoPoint":{"lat":34.69379,"lon":135.50107}}]}},"resultsSection":{"participantFlowModule":{"groups":[{"id":"FG000","title":"Arm A: ASC-01 Placebo First","description":"Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.\n\nPeriod II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting."},{"id":"FG001","title":"Arm B: Sertraline First","description":"Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.\n\nPeriod II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting."}],"periods":[{"title":"Period I","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"25"},{"groupId":"FG001","numSubjects":"25"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}]}],"dropWithdraws":[{"type":"Physician Decision","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"4"}]}]},{"title":"Wash-out Period (at Least 10 Days)","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"24"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}],"dropWithdraws":[{"type":"Adverse Event","reasons":[{"groupId":"FG000","numSubjects":"1"},{"groupId":"FG001","numSubjects":"0"}]}]},{"title":"Period II","milestones":[{"type":"STARTED","achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"23"},{"groupId":"FG001","numSubjects":"21"}]},{"type":"NOT COMPLETED","achievements":[{"groupId":"FG000","numSubjects":"0"},{"groupId":"FG001","numSubjects":"0"}]}]}]},"baselineCharacteristicsModule":{"populationDescription":"Safety Analysis Set: subjects who received the investigational medicinal product (IMP) at least once and from whom data on at least 1 safety endpoint were obtained after the start of IMP administration.","groups":[{"id":"BG000","title":"Arm A: ASC-01 Placebo First","description":"Period I: A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.\n\nPeriod II: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting."},{"id":"BG001","title":"Arm B: Sertraline First","description":"Period I: A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.\n\nPeriod II: A single oral dose of ASC-01 placebo (sertraline 100 mg) was administered after 10 or more hours of fasting."},{"id":"BG002","title":"Total","description":"Total of all reporting groups"}],"denoms":[{"units":"Participants","counts":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]}],"measures":[{"title":"Age, Continuous","paramType":"MEAN","dispersionType":"STANDARD_DEVIATION","unitOfMeasure":"years","classes":[{"categories":[{"measurements":[{"groupId":"BG000","value":"25.2","spread":"3.7"},{"groupId":"BG001","value":"28.5","spread":"4.3"},{"groupId":"BG002","value":"26.8","spread":"4.3"}]}]}]},{"title":"Sex: Female, Male","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"categories":[{"title":"Female","measurements":[{"groupId":"BG000","value":"0"},{"groupId":"BG001","value":"0"},{"groupId":"BG002","value":"0"}]},{"title":"Male","measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]}]}]},{"title":"Race/Ethnicity, Customized","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Japanese","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]}]}]},{"title":"Region of Enrollment","paramType":"COUNT_OF_PARTICIPANTS","unitOfMeasure":"Participants","classes":[{"title":"Japan","categories":[{"measurements":[{"groupId":"BG000","value":"25"},{"groupId":"BG001","value":"25"},{"groupId":"BG002","value":"50"}]}]}]}]},"outcomeMeasuresModule":{"outcomeMeasures":[{"type":"PRIMARY","title":"Peak Plasma Concentration (Cmax) of Sertraline","populationDescription":"Bioequivalence Analysis Set comprised all subjects for whom the Cmax and AUCt were determined in both Period I and Period II.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng/mL","timeFrame":"predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose","groups":[{"id":"OG000","title":"ASC-01 Placebo","description":"A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting."},{"id":"OG001","title":"Sertraline","description":"A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"44"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"28.3","spread":"8.31"},{"groupId":"OG001","value":"28.8","spread":"10.1"}]}]}]},{"type":"SECONDARY","title":"Area Under the Plasma Concentration-time Curve From Time 0 to the Last Observable Concentration at Time t (AUCt) for Sertraline","populationDescription":"Bioequivalence Analysis Set comprised all subjects for whom the Cmax and AUCt were determined in both Period I and Period II.","reportingStatus":"POSTED","paramType":"MEAN","dispersionType":"Standard Deviation","unitOfMeasure":"ng*h/mL","timeFrame":"predose, 1, 2, 3, 4, 5, 6, 8, 12, 24, 48, 72, 96, 144 and 168 hours postdose","groups":[{"id":"OG000","title":"ASC-01 Placebo","description":"A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting."},{"id":"OG001","title":"Sertraline","description":"A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting."}],"denoms":[{"units":"Participants","counts":[{"groupId":"OG000","value":"44"},{"groupId":"OG001","value":"44"}]}],"classes":[{"categories":[{"measurements":[{"groupId":"OG000","value":"835","spread":"363"},{"groupId":"OG001","value":"856","spread":"421"}]}]}]}]},"adverseEventsModule":{"frequencyThreshold":"2","timeFrame":"Treatment-emergent adverse events occurring up to 8 days after dosing date were collected.","description":"A single dose of ASC-01 placebo or sertraline tablet was administered to 25 subjects each in Period I, and a single dose of ASC-01 placebo or sertraline tablet was administered to 21 and 23 subjects, respectively, in Period II. In this trial, safety data for each formulation were summarized based on subjects treated with the respective formulation, and safety was therefore evaluated in 46 subjects receiving ASC-01 placebo and 48 subjects receiving sertraline tablets.","eventGroups":[{"id":"EG000","title":"ASC-01 Placebo","description":"A single oral dose of ASC-01 placebo (aripiprazole 0 mg/sertraline 100 mg) was administered after 10 or more hours of fasting.","deathsNumAffected":0,"deathsNumAtRisk":46,"seriousNumAffected":0,"seriousNumAtRisk":46,"otherNumAffected":9,"otherNumAtRisk":46},{"id":"EG001","title":"Sertraline","description":"A single oral dose of sertraline tablets (sertraline 100 mg) was administered after 10 or more hours of fasting.","deathsNumAffected":0,"deathsNumAtRisk":48,"seriousNumAffected":0,"seriousNumAtRisk":48,"otherNumAffected":19,"otherNumAtRisk":48}],"otherEvents":[{"term":"Nausea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":5,"numAtRisk":46},{"groupId":"EG001","numAffected":9,"numAtRisk":48}]},{"term":"Diarrhoea","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":3,"numAtRisk":46},{"groupId":"EG001","numAffected":10,"numAtRisk":48}]},{"term":"Vomiting","organSystem":"Gastrointestinal disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46},{"groupId":"EG001","numAffected":4,"numAtRisk":48}]},{"term":"Blood bilirubin increased","organSystem":"Investigations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]},{"term":"Blood sodium decreased","organSystem":"Investigations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":2,"numAtRisk":48}]},{"term":"Liver function test abnormal","organSystem":"Investigations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":0,"numAtRisk":48}]},{"term":"White blood cell count increased","organSystem":"Investigations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":0,"numAtRisk":48}]},{"term":"Blood creatine phosphokinase increased","organSystem":"Investigations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]},{"term":"Eosinophil count increased","organSystem":"Investigations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]},{"term":"Dizziness","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":0,"numAtRisk":48}]},{"term":"Headache","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]},{"term":"Somnolence","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]},{"term":"Tremor","organSystem":"Nervous system disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]},{"term":"Malaise","organSystem":"General disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":0,"numAtRisk":48}]},{"term":"Influenza","organSystem":"Infections and infestations","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":0,"numAtRisk":48}]},{"term":"Ketonuria","organSystem":"Renal and urinary disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":1,"numAtRisk":46},{"groupId":"EG001","numAffected":2,"numAtRisk":48}]},{"term":"Oropharyngeal pain","organSystem":"Respiratory, thoracic and mediastinal disorders","sourceVocabulary":"MedDRA Ver. 16.0","assessmentType":"NON_SYSTEMATIC_ASSESSMENT","stats":[{"groupId":"EG000","numAffected":0,"numAtRisk":46},{"groupId":"EG001","numAffected":1,"numAtRisk":48}]}]},"moreInfoModule":{"certainAgreement":{"piSponsorEmployee":false,"restrictiveAgreement":false},"pointOfContact":{"title":"Director of Clinical Trials","organization":"Otsuka Pharmaceutical Co., LTD.","email":"CL_OPCJ_RDA_Team@otsuka.jp","phone":"+81-3-6361-7366"}}},"derivedSection":{"miscInfoModule":{"versionHolder":"2026-10-13"}},"hasResults":true}