Ignite Creation Date:
2025-12-24 @ 4:35 PM
Ignite Modification Date:
2026-01-02 @ 1:51 AM
Study NCT ID:
NCT01536366
Status:
COMPLETED
Last Update Posted:
2015-08-20
First Post:
2012-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide
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'}, {'id': 'C072379', 'term': 'repaglinide'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jose.rocha@bial.com', 'phone': '+351 22 9866100', 'title': 'Head of Clinical Research', 'organization': 'BIAL - Portela & Cª, S.A.'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'BIA 9-1067 + Repaglinide', 'description': 'BIA 9-1067 25 mg Repaglinide 0.5 mg', 'otherNumAtRisk': 24, 'otherNumAffected': 7, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Repaglinide', 'description': 'Repaglinide 0.5 mg', 'otherNumAtRisk': 27, 'otherNumAffected': 8, 'seriousNumAtRisk': 27, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Presyncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Oral herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Otitis externa', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Vulvovaginal candidiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Foot fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Joint injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Investigations'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Investigations'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 27, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax - Maximum Observed Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 + Repaglinide', 'description': 'BIA 9-1067 25 mg Repaglinide 0.5 mg'}, {'id': 'OG001', 'title': 'Repaglinide', 'description': 'Repaglinide 0.5 mg'}], 'classes': [{'title': 'BIA 9-1067', 'categories': [{'measurements': [{'value': '400', 'spread': '245.2', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'BIA 9-1067 was not administered.', 'groupId': 'OG001'}]}]}, {'title': 'Repaglinide', 'categories': [{'measurements': [{'value': '11.6', 'spread': '5.22', 'groupId': 'OG000'}, {'value': '9.76', 'spread': '5.42', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax - Time of Occurrence of Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 + Repaglinide', 'description': 'BIA 9-1067 25 mg Repaglinide 0.5 mg'}, {'id': 'OG001', 'title': 'Repaglinide', 'description': 'Repaglinide 0.5 mg'}], 'classes': [{'title': 'BIA 9-1067', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': 'NA', 'comment': 'BIA 9-1067 was not administered', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Repaglinide', 'categories': [{'measurements': [{'value': '0.5', 'groupId': 'OG000', 'lowerLimit': '0.5', 'upperLimit': '0.75'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '3.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 + Repaglinide', 'description': 'BIA 9-1067 25 mg Repaglinide 0.5 mg'}, {'id': 'OG001', 'title': 'Repaglinide', 'description': 'Repaglinide 0.5 mg'}], 'classes': [{'title': 'BIA 9-1067', 'categories': [{'measurements': [{'value': '979', 'spread': '607', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'BIA 9-1067 was not administered', 'groupId': 'OG001'}]}]}, {'title': 'Repaglinide', 'categories': [{'measurements': [{'value': '14.2', 'spread': '4.96', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '5.33', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 9-1067 + Repaglinide', 'description': 'BIA 9-1067 25 mg Repaglinide 0.5 mg'}, {'id': 'OG001', 'title': 'Repaglinide', 'description': 'Repaglinide 0.5 mg'}], 'classes': [{'title': 'BIA 9-1067', 'categories': [{'measurements': [{'value': '1015', 'spread': '608', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'BIA 9-1067 was not administered', 'groupId': 'OG001'}]}]}, {'title': 'Repaglinide', 'categories': [{'measurements': [{'value': '15.0', 'spread': '4.95', 'groupId': 'OG000'}, {'value': '14.1', 'spread': '5.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group 1', 'description': 'Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide\n\nBIA 9-1067: 25 mg BIA 9-1067 (single-dose)\n\nRepaglinide: 0.5 mg repaglinide (single-dose)'}, {'id': 'FG001', 'title': 'Group 2', 'description': 'Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide\n\nBIA 9-1067: 25 mg BIA 9-1067 (single-dose)\n\nRepaglinide: 0.5 mg repaglinide (single-dose)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'BIA 9-1067 + Repaglinide', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'Repaglinide', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Group 1', 'description': 'Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide\n\nBIA 9-1067: 25 mg BIA 9-1067 (single-dose)\n\nRepaglinide: 0.5 mg repaglinide (single-dose)'}, {'id': 'BG001', 'title': 'Group 2', 'description': 'Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide\n\nBIA 9-1067: 25 mg BIA 9-1067 (single-dose)\n\nRepaglinide: 0.5 mg repaglinide (single-dose)'}, {'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': '14', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '27', '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': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-22', 'studyFirstSubmitDate': '2012-01-23', 'resultsFirstSubmitDate': '2015-07-22', 'studyFirstSubmitQcDate': '2012-02-16', 'lastUpdatePostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-07-22', 'studyFirstPostDateStruct': {'date': '2012-02-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax - Maximum Observed Plasma Concentration', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.'}], 'secondaryOutcomes': [{'measure': 'Tmax - Time of Occurrence of Cmax', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.'}, {'measure': 'AUC0-t - Area Under the Plasma Concentration-time Curve From Time 0 to Last Observed Concentration', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.'}, {'measure': 'AUC0-∞ - Area Under the Plasma Concentration-time Curve From Time 0 to Infinity', 'timeFrame': 'pre-dose, and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 12, 16 and 24 h post-dose.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson Disease', 'BIA 9-1067'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the CYP2C8 inhibition by BIA 9-1067.', 'detailedDescription': 'Single-centre, open-label, randomised, two-way crossover study in healthy young male and female volunteers'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Able and willing to give written informed consent.\n* Male or female subjects aged between 18 and 45 years, inclusive.\n* Subjects of body mass index (BMI) between 19 and 30 kg/m2, inclusive.\n* Healthy as determined by pre-study medical history, physical examination, vital signs, complete neurological examination and 12-lead ECG.\n* Negative tests for HBsAg, anti-HCVAb and HIV-1 and HIV-2 Ab at screening.\n* Clinical laboratory test results clinically acceptable at screening and admission to each treatment period.\n* Negative screen for alcohol and drugs of abuse at screening and admission to each treatment period.\n* Non-smokers or ex-smokers for at least 3 months.\n* (If female) She was not of childbearing potential by reason of surgery or, if of childbearing potential, she used one of the following methods of contraception: double barrier or intrauterine device.\n* (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.\n\nExclusion Criteria:\n\n* 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* Clinically relevant surgical history.\n* Any abnormality in the coagulation tests.\n* Any abnormality in the liver function tests.\n* A history of relevant atopy or drug hypersensitivity.\n* History of alcoholism or drug abuse.\n* Consumed more than 14 units of alcohol a week.\n* Significant infection or known inflammatory process at screening or admission to each treatment period.\n* Acute gastrointestinal symptoms (e.g., nausea, vomiting, diarrhoea, heartburn) at the time of screening or admission to each treatment period.\n* Had used medicines within 2 weeks of admission to first period that may have affected the safety or other study assessments, in the investigator's opinion.\n* Had previously received BIA 9-1067.\n* Had used any investigational drug or participated in any clinical trial within 6 months prior to screening.\n* Had participated in more than 2 clinical trials within the 12 months prior to screening.\n* Had donated or received any blood or blood products within the 3 months prior to screening.\n* Vegetarians, vegans or had medical dietary restrictions.\n* Cannot communicate reliably with the investigator.\n* Unlikely to co-operate with the requirements of the study.\n* Unwilling or unable to gave written informed consent.\n* Employees at BIAL - Portela \\& Cª, S.A.\n* (If female) She was pregnant or breast-feeding.\n* (If female) She was of childbearing potential and she did not used an approved effective contraceptive method (double-barrier or intra-uterine device) or she used oral contraceptives."}, 'identificationModule': {'nctId': 'NCT01536366', 'briefTitle': 'Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Effect of BIA 9-1067 on the Pharmacokinetics of Repaglinide in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BIA-91067-115'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'Period 1: BIA 9-1067 + repaglinide Period 2: Repaglinide', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Repaglinide']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'Period 1: Repaglinide Period 2: BIA 9-1067 + repaglinide', 'interventionNames': ['Drug: BIA 9-1067', 'Drug: Repaglinide']}], 'interventions': [{'name': 'BIA 9-1067', 'type': 'DRUG', 'otherNames': ['OPC, Opicapone'], 'description': '25 mg BIA 9-1067 (single-dose)', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Repaglinide', 'type': 'DRUG', 'otherNames': ['Novonorm®'], 'description': '0.5 mg repaglinide (single-dose)', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4745-457', 'city': 'S. Mamede Do Coronado', 'country': 'Portugal', 'facility': 'Bial - Portela & Cª, S.A.'}], 'overallOfficials': [{'name': 'Manuel Vaz-da-Silva, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BIAL - Portela & Cª S.A.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}