Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-29 @ 10:09 AM
Study NCT ID:
NCT06312566
Status:
COMPLETED
Last Update Posted:
2025-06-06
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C482793', 'term': 'brivaracetam'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'UCBCares@ucb.com', 'phone': '001 844 599 2273', 'title': 'UCB', 'organization': 'Cares'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline to end of Safety Follow-Up (up to 25 days)', 'description': 'A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsened in intensity following exposure to IMP. SS included all randomized participants who received at least 1 dose of the IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'BRV Tablet', 'description': 'Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.', 'otherNumAtRisk': 63, 'deathsNumAtRisk': 63, 'otherNumAffected': 2, 'seriousNumAtRisk': 63, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BRV Dry Syrup', 'description': 'Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.', 'otherNumAtRisk': 64, 'deathsNumAtRisk': 64, 'otherNumAffected': 6, 'seriousNumAtRisk': 64, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver 18.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 64, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA ver 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRV Tablet', 'description': 'Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}, {'id': 'OG001', 'title': 'BRV Dry Syrup', 'description': 'Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.963', 'spread': '24.1', 'groupId': 'OG000'}, {'value': '2.878', 'spread': '19.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Dry Syrup/ Tablet', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '92.016', 'paramValue': '0.9726', 'ciLowerLimit': '0.9257', 'ciUpperLimit': '1.022', 'statisticalMethod': 'Linear mixed model analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 92.016% CI limits for Cmax,ss was within the 0.80 to 1.25 range.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose', 'description': 'Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.', 'unitOfMeasure': 'microgram per milliliter (μg/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) set included all participants who were randomized, received at least 1 dose of active IMP, and had at least 1 quantifiable post-baseline PK measurement.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRV Tablet', 'description': 'Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}, {'id': 'OG001', 'title': 'BRV Dry Syrup', 'description': 'Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.55', 'spread': '17.4', 'groupId': 'OG000'}, {'value': '18.53', 'spread': '16.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Ratio of Dry Syrup/ Tablet', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '92.016', 'paramValue': '0.9999', 'ciLowerLimit': '0.9881', 'ciUpperLimit': '1.012', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Bioequivalence between the BRV tablet (reference) and BRV dry syrup (test) formulations were concluded if the 90% CI limits for AUC(tau) was within the 0.80 to 1.25 range.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose', 'description': 'AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.', 'unitOfMeasure': 'hours*μg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK set included all participants who were randomized, received at least 1 dose of active IMP, and had at least 1 quantifiable post-Baseline PK measurement.'}, {'type': 'SECONDARY', 'title': 'Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRV Tablet', 'description': 'Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}, {'id': 'OG001', 'title': 'BRV Dry Syrup', 'description': 'Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '10.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Safety Follow-up (up to 25 days)', 'description': 'An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS included all randomized participants who received at least 1 dose of the IMP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRV Tablet', 'description': 'Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}, {'id': 'OG001', 'title': 'BRV Dry Syrup', 'description': 'Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Safety Follow-up (up to 25 days)', 'description': 'A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:\n\nResults in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Is a congenital anomaly or birth defect, Results in persistent disability/incapacity Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS included all randomized participants who received at least 1 dose of the IMP.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BRV Tablet', 'description': 'Participants received BRV 50 mg tablet twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}, {'id': 'OG001', 'title': 'BRV Dry Syrup', 'description': 'Participants received BRV 50 mg dry syrup twice daily on Day 1 and Day 2 followed by a single administration on Day 3, under fasting conditions in Dosing Period 1 and Dosing Period 2 of the study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Baseline to end of Safety Follow-up (up to 25 days)', 'description': 'Percentage of participants with TEAEs leading to discontinuation were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS included all randomized participants who received at least 1 dose of the IMP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup', 'description': 'Dosing period 1 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days.'}, {'id': 'FG001', 'title': 'Sequence BRV Dry Syrup - BRV Tablet', 'description': 'Dosing period 1 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'comment': '1 participant randomized to the BRV dry syrup - BRV tablet treatment sequence and discontinued the study due to a protocol violation before BRV tablet administration in Dosing Period 2.', 'groupId': 'FG001', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'The study started to enroll participants in March 2024 and concluded in June 2024.', 'preAssignmentDetails': 'The Participant Flow refers to the Randomized Set.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence Brivaracetam (BRV) Tablet - BRV Dry Syrup', 'description': 'Dosing period 1 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg tablet formulation. Dosing period 2 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50mg as dry syrup twice daily; on Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. The final IMP administration in Dosing Period 1 and the first investigational medicinal product (IMP) administration in Dosing Period 2 were separated by a washout period of 6-10 days.'}, {'id': 'BG001', 'title': 'Sequence BRV Dry Syrup - BRV Tablet', 'description': 'Dosing period 1 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): on Day 1 and Day 2 each participant received a dose of BRV 50 mg as dry syrup twice daily. On Day 3, each participant received a single morning dose of BRV 50 mg as dry syrup. Dosing period 2 consisted of 5 days (Day -1 \\[1 day before administration of IMP\\] to Day 4): On Day 1 and Day 2 each participant received a dose of BRV 50 mg tablet formulation twice daily; on Day 3 of Dosing Period 2, each participant received a single morning dose of BRV 50 mg tablet formulation. The final IMP administration in Dosing Period 1 and the first IMP administration in Dosing Period 2 were separated by a washout period of 6-10 days.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.5', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '33.8', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '33.6', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '19 - 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', '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': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Not Hispanic or Latino', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '64', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline characteristics refers to the safety set (SS) which included all randomized participants who received at least 1 dose of the investigational medicinal product (IMP).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-14', 'size': 1931298, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-05-20T10:08', 'hasProtocol': True}, {'date': '2024-06-28', 'size': 1917719, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-05-20T10:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-21', 'studyFirstSubmitDate': '2024-03-08', 'resultsFirstSubmitDate': '2025-05-21', 'studyFirstSubmitQcDate': '2024-03-08', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-21', 'studyFirstPostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration at Steady State [Cmax(ss)] After Multiple Doses of Brivaracetam', 'timeFrame': 'Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose', 'description': 'Cmax,ss is the maximum plasma concentration of brivaracetam at steady state.'}, {'measure': 'Area Under the Curve During a Dosing Interval at Steady State [AUC(Tau)] After Multiple Doses of Brivaracetam', 'timeFrame': 'Day 1: before the morning and evening doses (0 and 12 hr); Day 2: before the morning and evening doses (24 and 36 hr); Day 3: Predose (48 hr) and 10 min, 15 min, 20 min, 30 min, 45 min, 60 min, 75 min, 90 min, 2 hr, 6 hr, 9 hr, and 12 hr postdose', 'description': 'AUCtau was area under the curve during a dosing interval at steady state of brivaracetam.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Study Participants With Treatment-emergent Adverse Events (TEAEs)', 'timeFrame': 'From Baseline to end of Safety Follow-up (up to 25 days)', 'description': 'An AE was any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of IMP, whether or not considered related to the IMP. A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP.'}, {'measure': 'Percentage of Study Participants With Treatment-emergent Serious Adverse Events (TESAEs)', 'timeFrame': 'From Baseline to end of Safety Follow-up (up to 25 days)', 'description': 'A TEAE was defined as any AE with a start date/time on or after the first dose of IMP or any unresolved event already present before administration of IMP that worsens in intensity following exposure to IMP. A serious adverse event (SAE) was defined as any untoward medical occurrence that at any dose:\n\nResults in death, Is life-threatening, Requires in patient hospitalization or prolongation of existing hospitalization, Is a congenital anomaly or birth defect, Results in persistent disability/incapacity Is an infection that requires treatment parenteral antibiotics, Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above.'}, {'measure': 'Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Discontinuation', 'timeFrame': 'From Baseline to end of Safety Follow-up (up to 25 days)', 'description': 'Percentage of participants with TEAEs leading to discontinuation were reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brivaracetam', 'Healthy Study Participants', 'Phase 1', 'BRV'], 'conditions': ['Healthy Study Participants']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate the bioequivalence between the BRV tablet and BRV dry syrup after multiple oral doses in healthy male Japanese participants.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant must be between 20 to 50 years of age (inclusive) at the time of signing the informed consent form (ICF)\n* Participant is of Japanese descent as evidenced by appearance and verbal confirmation of familial heritage (ie, participant has all 4 Japanese grandparents born in Japan)\n* Participant is male\n\nExclusion Criteria:\n\n* Participant has a known hypersensitivity to any components of the investigational medicinal product (IMP) formulations\n* Participant has participated in another study of an IMP (and/or an investigational device) within the previous 30 days or within 5 times the half-life (whichever is longer) of the first dose of BRV in this study or is currently participating in another study of an IMP (and/or an investigational device)\n* Participant tests positive for alcohol and/or prohibited concomitant drugs (including cotinine) at the Screening Visit or on Day-1\n* Participant has donated blood or plasma or has experienced blood loss ≥400 mL within 90 days, ≥200 mL within 30 days, or has donated any blood or plasma within 14 days before first administration of IMP\n* Participant is a current smoker or has used nicotine-containing products (eg, tobacco, patches, gum) within 30 days before the first administration of IMP'}, 'identificationModule': {'nctId': 'NCT06312566', 'briefTitle': 'A Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Japanese Male Study Participants', 'organization': {'class': 'INDUSTRY', 'fullName': 'UCB Pharma'}, 'officialTitle': 'A Multiple-Dose, Open-Label, Randomized, 2-Way Cross-Over Study to Assess the Bioequivalence Between Brivaracetam Tablet and Dry Syrup in Healthy Male Japanese Participants', 'orgStudyIdInfo': {'id': 'EP0231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A-B', 'description': 'Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence A-B at pre-specified timepoints.', 'interventionNames': ['Drug: brivaracetam (BRV) tablet', 'Drug: brivaracetam (BRV) dry syrup']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B-A', 'description': 'Study participants randomized to this arm will receive multiple doses of brivaracetam tablet (Treatment A) as reference and multiple doses of brivaracetam dry syrup (Treatment B) as test in the treatment sequence B-A at pre-specified timepoints.', 'interventionNames': ['Drug: brivaracetam (BRV) tablet', 'Drug: brivaracetam (BRV) dry syrup']}], 'interventions': [{'name': 'brivaracetam (BRV) tablet', 'type': 'DRUG', 'otherNames': ['BRV', 'Briviact'], 'description': 'Study participants will receive multiple-doses of brivaracetam tablet (reference - Treatment A) administered orally.', 'armGroupLabels': ['Treatment A-B', 'Treatment B-A']}, {'name': 'brivaracetam (BRV) dry syrup', 'type': 'DRUG', 'otherNames': ['BRV'], 'description': 'Study participants will receive multiple-doses of brivaracetam dry syrup (test - Treatment B) administered orally.', 'armGroupLabels': ['Treatment A-B', 'Treatment B-A']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sumida-ku', 'country': 'Japan', 'facility': 'EP0231 1'}], 'overallOfficials': [{'name': 'UCB Cares', 'role': 'STUDY_DIRECTOR', 'affiliation': '001 844 599 2273 (UCB)'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Due to the small sample size in this trial, IPD cannot be adequately anonymized i.e., there is a reasonable likelihood that individual participants could be re-identified. For this reason, data from this trial cannot be shared.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UCB Biopharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}