Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2026-02-19 @ 3:19 AM
Study NCT ID:
NCT02169466
Status:
COMPLETED
Last Update Posted:
2015-11-03
First Post:
2012-01-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C549349', 'term': 'opicapone'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinical.trials@bial.com', 'phone': '+351 229 866 100', 'title': 'Head of Clinical Research', 'organization': 'Bial - Portela & Cª, S.A.'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Just before drug administration until 72 h post-dose', 'eventGroups': [{'id': 'EG000', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 25 mg OPC Opicapone', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 50 mg OPC Opicapone', 'otherNumAtRisk': 22, 'otherNumAffected': 4, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 100 mg OPC Opicapone', 'otherNumAtRisk': 22, 'otherNumAffected': 3, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Placebo', 'description': 'Placebo, PLC', 'otherNumAtRisk': 21, 'otherNumAffected': 2, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rhinorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 21, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 21, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Plasma Concentration of Levodopa', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 25 mg OPC Opicapone Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation'}, {'id': 'OG001', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 50 mg OPC Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 100 mg OPC Opicapone'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo, PLC Of the initialy enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation'}], 'classes': [{'categories': [{'measurements': [{'value': '314', 'spread': '110', 'groupId': 'OG000'}, {'value': '266', 'spread': '77.5', 'groupId': 'OG001'}, {'value': '263', 'spread': '94.9', 'groupId': 'OG002'}, {'value': '260', 'spread': '119', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.'}, {'type': 'PRIMARY', 'title': 'AUC0-t - Area Under the Plasma Concentration-time Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation'}, {'id': 'OG001', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 50 mg OPC Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 100 mg OPC Opicapone'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation'}], 'classes': [{'categories': [{'measurements': [{'value': '1084', 'spread': '398', 'groupId': 'OG000'}, {'value': '1064', 'spread': '365', 'groupId': 'OG001'}, {'value': '1140', 'spread': '592', 'groupId': 'OG002'}, {'value': '933', 'spread': '422', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.'}, {'type': 'PRIMARY', 'title': 'AUC0-∞ - AUC From Time Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '19', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 25 mg OPC Opicapone Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation'}, {'id': 'OG001', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 50 mg OPC Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 100 mg OPC Opicapone'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo, PLC Of the initially enrolled 21 subjects, 1 subject was not considered for the accountability as he was withdrawn from study participation'}], 'classes': [{'categories': [{'measurements': [{'value': '1190', 'spread': '441', 'groupId': 'OG000'}, {'value': '1181', 'spread': '373', 'groupId': 'OG001'}, {'value': '1326', 'spread': '604', 'groupId': 'OG002'}, {'value': '1086', 'spread': '380', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.'}, {'type': 'PRIMARY', 'title': 'Tmax - Time to Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 25 mg', 'description': 'BIA 9-1067 25 mg OPC Opicapone'}, {'id': 'OG001', 'title': 'BIA 9-1067 50 mg', 'description': 'BIA 9-1067 50 mg OPC Opicapone'}, {'id': 'OG002', 'title': 'BIA 9-1067 100 mg', 'description': 'BIA 9-1067 100 mg OPC Opicapone'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Placebo, PLC'}], 'classes': [{'categories': [{'measurements': [{'value': '2.50', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.50', 'groupId': 'OG001', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '2.00', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '2.00', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '4.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: tmax - time to Cmax', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'According to the protocol, the "pharmacokinetic population" should include all subjects who had valid data for all treatment periods.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BIA 9-1067: 25, 50, 100, Placebo', 'description': 'Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'FG001', 'title': 'BIA 9-1067: 50, 100, Placebo, 25', 'description': 'Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'FG002', 'title': 'BIA 9-1067: 100, Placebo, 25, 50', 'description': 'Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'FG003', 'title': 'BIA 9-1067: Placebo, 25, 50, 100', 'description': 'Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': '25 mg BIA 9-1067', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': '50 mg BIA 9-1067', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': '100 mg BIA 9-1067', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'Placebo', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'BIA 9-1067: 25, 50, 100, Placebo', 'description': 'Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'BG001', 'title': 'BIA 9-1067: 50, 100, Placebo, 25', 'description': 'Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'BG002', 'title': 'BIA 9-1067: 100, Placebo, 25, 50', 'description': 'Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'BG003', 'title': 'BIA 9-1067: Placebo, 25, 50, 100', 'description': 'Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)\n\nBIA 9-1067: OPC, Opicapone\n\nPlacebo: PLC, Placebo\n\nMadopar® HBS: controlled-release levodopa 100 mg/benserazide 25 mg'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-02', 'studyFirstSubmitDate': '2012-01-20', 'resultsFirstSubmitDate': '2015-01-09', 'studyFirstSubmitQcDate': '2014-06-19', 'lastUpdatePostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-10-02', 'studyFirstPostDateStruct': {'date': '2014-06-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Plasma Concentration of Levodopa', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: Levodopa maximum observed plasma concentration (Cmax) (ng/mL)'}, {'measure': 'AUC0-t - Area Under the Plasma Concentration-time Curve', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: Area under the plasma concentration-time curve for levodopa'}, {'measure': 'AUC0-∞ - AUC From Time Zero to Infinity', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: Area under the plasma concentration-time curve from time zero to infinity for levodopa'}, {'measure': 'Tmax - Time to Cmax', 'timeFrame': 'pre-dose, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 16, 24, 48 and 72 h post-dose.', 'description': 'Primary pharmacokinetic parameter: tmax - time to Cmax'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Parkinson's disease (PD)", 'Opicapone', 'BIA 9-1067'], 'conditions': ["Parkinson's Disease (PD)"]}, 'descriptionModule': {'briefSummary': 'To investigate the effect of three single oral doses of BIA 9-1067 (25 mg, 50 mg and 100 mg) on the levodopa pharmacokinetics when administered in combination with a single-dose of controlled-release levodopa 100 mg/benserazide 25 mg (Madopar HBS).', 'detailedDescription': 'Single centre, double-blind, randomized, placebo-controlled, crossover study with four consecutive single-dose treatment periods. The washout period between doses was to be at least10 days. On each treatment period (25, 50 and 100 mg BIA 9-1067 or placebo), after completion of pre-dose assessments, BIA 9-1067-Placebo was to be administered concomitantly with the dose of Madopar HBS; post-dose assessments were to be completed and subjects were to be discharged 72 h post-dose.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male subjects between 18 and 45 years, inclusive.\n* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.\n* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.\n* Subjects who had clinical laboratory test results that were clinically acceptable at screening and admission to first treatment period.\n* Subjects who had negative tests for hepatitis B surface antigen (HBsAg), anti-hepatitis C antibodies (HCV Ab), and Human immunodeficiency viruses -1 and -2 antibodies (HIV-1 and HIV-2 Ab) at screening.\n* Subjects who had/were negative for drugs of abuse at screening and admission to each treatment period.\n* Subjects who were non-smokers or who smoked ≤10 cigarettes or equivalent per day.\n* Subjects who were able and willing to give written informed consent.\n\nExclusion Criteria:\n\n* Subjects who did not conform to the above inclusion criteria, or\n* Subjects who had a clinically relevant history or presence of respiratory, gastrointestinal, renal, hepatic, haematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, endocrine, connective tissue diseases or disorders.\n* Subjects who had a clinically relevant surgical history.\n* Subjects who had a clinically relevant family history.\n* Subjects who had a history of relevant atopy.\n* Subjects who had a history of relevant drug hypersensitivity.\n* Subjects who had a history of glaucoma.\n* Subjects who had a history of alcoholism or drug abuse.\n* Subjects who consumed more than 21 units of alcohol a week.\n* Subjects who had a significant infection or known inflammatory process on screening or first admission.\n* Subjects who had acute gastrointestinal symptoms at the time of screening or first admission (e.g., nausea, vomiting, diarrhoea, heartburn).\n* Subjects who used medicines within 2 weeks of first admission that, in the opinion of the investigator, may affect the safety or other study assessments.\n* Subjects who used any investigational drug or participated in any clinical trial within 2 months of their first admission.\n* Subjects who donated or received any blood or blood products within the previous 2 months prior to screening.\n* Subjects who were vegetarians, vegans or have medical dietary restrictions.\n* Subjects who could not communicate reliably with the investigator.\n* Subjects who were unlikely to co-operate with the requirements of the study.\n* Subjects who were unwilling or unable to give written informed consent.\n* Subjects who were BIAL - Portela \\& Cª, SA employees.'}, 'identificationModule': {'nctId': 'NCT02169466', 'briefTitle': 'Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Pharmacokinetic-pharmacodynamic Interaction Between Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Benserazide: a Double-blind, Randomized, Four-way Crossover, Placebo-controlled Study in Healthy Male Subjects', 'orgStudyIdInfo': {'id': 'BIA-91067-109'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Period 1: BIA 9-1067 25 mg Period 2: BIA 9-1067 50 mg Period 3: BIA 9-1067 100 mg Period 4: Placebo\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Madopar® HBS']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Period 1: BIA 9-1067 50 mg Period 2: BIA 9-1067 100 mg Period 3: Placebo Period 4: BIA 9-1067 25 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Madopar® HBS']}, {'type': 'EXPERIMENTAL', 'label': 'Group 3', 'description': 'Period 1: BIA 9-1067 100 mg Period 2: Placebo Period 3: BIA 9-1067 25 mg Period 4: BIA 9-1067 50 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Madopar® HBS']}, {'type': 'EXPERIMENTAL', 'label': 'Group 4', 'description': 'Period 1: Placebo Period 2: BIA 9-1067 25 mg Period 3: BIA 9-1067 50 mg Period 4: BIA 9-1067 100 mg\n\nBIA 9-1067/Placebo was to be administered concomitantly with the dose of Madopar® HBS (Single-dose of controlled-release levodopa/benserazide 100/25 mg: 1 capsule of Madopar® HBS.)', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Placebo', 'Drug: Madopar® HBS']}], 'interventions': [{'name': 'BIA 9-1067', 'type': 'DRUG', 'otherNames': ['OPC, Opicapone'], 'description': 'OPC, Opicapone', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['PLC, Placebo'], 'description': 'PLC, Placebo', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}, {'name': 'Madopar® HBS', 'type': 'DRUG', 'description': 'controlled-release levodopa 100 mg/benserazide 25 mg', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4745-457', 'city': 'S. Mamede Do Coronado', 'state': 'Trofa', 'country': 'Portugal', 'facility': 'BIAL - Portela & Cª - Human Pharmacology Unit (UFH)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}