Ignite Creation Date:
2025-12-26 @ 11:12 PM
Ignite Modification Date:
2026-03-06 @ 12:34 AM
Study NCT ID:
NCT02288312
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2014-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C416835', 'term': 'eslicarbazepine acetate'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jose.rocha@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': {'eventGroups': [{'id': 'EG000', 'title': 'BIA 2-093 800 mg Fasting', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093', 'otherNumAtRisk': 18, 'otherNumAffected': 3, 'seriousNumAtRisk': 18, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BIA 2-093 800 mg Fed', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093', 'otherNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BIA 2-093 800 mg (2 x 400 mg)', 'description': 'Tablets 2 x 400 mg. Administration:Oral.\n\nBIA 2-093', 'otherNumAtRisk': 17, 'otherNumAffected': 2, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'CPK increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'sourceVocabulary': 'MedDRA 10.0'}, {'term': 'Tooth extraction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 17, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 17, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'sourceVocabulary': 'MedDRA 10.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax (BIA 2-005)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 800 mg Fasting', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG001', 'title': 'BIA 2-093 800 mg Fed', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG002', 'title': 'BIA 2-093 800 mg (2 x 400 mg)', 'description': 'Tablets 2 x 400 mg. Administration:Oral.\n\nBIA 2-093'}], 'classes': [{'categories': [{'measurements': [{'value': '10973', 'spread': '2628', 'groupId': 'OG000'}, {'value': '11044', 'spread': '2495', 'groupId': 'OG001'}, {'value': '11022', 'spread': '2748', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-t (BIA 2-005)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 800 mg Fasting', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG001', 'title': 'BIA 2-093 800 mg Fed', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG002', 'title': 'BIA 2-093 800 mg (2 x 400 mg)', 'description': 'Tablets 2 x 400 mg. Administration:Oral.\n\nBIA 2-093'}], 'classes': [{'categories': [{'measurements': [{'value': '241651', 'spread': '50381', 'groupId': 'OG000'}, {'value': '234092', 'spread': '50510', 'groupId': 'OG001'}, {'value': '242375', 'spread': '48599', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Tmax (BIA 2-005)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 800 mg Fasting', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG001', 'title': 'BIA 2-093 800 mg Fed', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG002', 'title': 'BIA 2-093 800 mg (2 x 400 mg)', 'description': 'Tablets 2 x 400 mg. Administration:Oral.\n\nBIA 2-093'}], 'classes': [{'categories': [{'measurements': [{'value': '2.64', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '2.75', 'spread': '2.31', 'groupId': 'OG001'}, {'value': '2.56', 'spread': '1.58', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'AUC0-∞ (BIA 2-005)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'BIA 2-093 800 mg Fasting', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG001', 'title': 'BIA 2-093 800 mg Fed', 'description': 'Tablets 800 mg. Administration:Oral.\n\nBIA 2-093'}, {'id': 'OG002', 'title': 'BIA 2-093 800 mg (2 x 400 mg)', 'description': 'Tablets 2 x 400 mg. Administration:Oral.\n\nBIA 2-093'}], 'classes': [{'categories': [{'measurements': [{'value': '243808', 'spread': '50464', 'groupId': 'OG000'}, {'value': '236089', 'spread': '50764', 'groupId': 'OG001'}, {'value': '244821', 'spread': '48873', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)', 'unitOfMeasure': 'ng.h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Group A', 'description': 'Period 1 - ESL 800 mg, in fasting (4 days) Period 2 - ESL 800 mg, in fed (4 days) Period 3 - ESL 800 mg (2x400mg), in fasting (4 days)\n\nWashout periods - 7 days between dosing days'}, {'id': 'FG001', 'title': 'Group B', 'description': 'Period 1 - ESL 800 mg (2x400mg), in fasting (4 days) Period 2 - ESL 800 mg, in fasting (4 days) Period 3 - ESL 800 mg, in fed (4 days)\n\nWashout periods - 7 days between dosing days'}, {'id': 'FG002', 'title': 'Group C', 'description': 'Period 1 - ESL 800 mg, in fed (4 days) Period 2 - ESL 800 mg (2x400mg), in fasting (4 days) Period 3 - ESL 800 mg, in fasting (4 days)\n\nWashout periods - 7 days between dosing days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence A', 'description': 'Period 1 - ESL 800 mg, in fasting Period 2 - ESL 800 mg, in fed Period 3 - ESL 800 mg (2x400mg), in fasting'}, {'id': 'BG001', 'title': 'Sequence B', 'description': 'Period 1 - ESL 800 mg (2x400mg), in fasting Period 2 - ESL 800 mg, in fasting Period 3 - ESL 800 mg, in fed'}, {'id': 'BG002', 'title': 'Sequence C', 'description': 'Period 1 - ESL 800 mg, in fed Period 2 - ESL 800 mg (2x400mg), in fasting Period 3 - ESL 800 mg, in fasting'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}]}], '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': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-19', 'studyFirstSubmitDate': '2014-11-07', 'resultsFirstSubmitDate': '2014-11-28', 'studyFirstSubmitQcDate': '2014-11-07', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-12-19', 'studyFirstPostDateStruct': {'date': '2014-11-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax (BIA 2-005)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'Cmax (BIA 2-005) - maximum observed plasma drug concentration of BIA 2-005 (BIA 2-093 metabolite)'}], 'secondaryOutcomes': [{'measure': 'AUC0-t (BIA 2-005)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'AUC0-t (BIA 2-005) - the area under the plasma concentration-time curve from time zero to the last sampling time at which BIA 2-005 concentrations are at or above the limit of quantification, calculated by the linear trapezoidal rule (BIA 2-005 is a BIA 2-093 metabolite)'}, {'measure': 'Tmax (BIA 2-005)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'tmax (BIA 2-005) - the time of occurrence of Cmax of BIA 2-005 (BIA 2-005 is a BIA 2-093 metabolite)'}, {'measure': 'AUC0-∞ (BIA 2-005)', 'timeFrame': 'pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48 and 72 hours postdose.', 'description': 'AUC0-∞ (BIA 2-005) - the area under the plasma BIA 2-005 concentration versus time curve from time zero to infinity, calculated from AUC0-t + (Clast/λz), where Clast is the last quantifiable concentration and λz the apparent terminal rate constant; (BIA 2-005 is a BIA 2-093 metabolite)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects.', 'detailedDescription': 'Single-centre, open-label, randomised, gender-balanced, 3-way crossover, 3-period, 3-sequence study in 18 healthy male and female subjects. The study consisted of 3 periods separated by a washout of 7 days or more between doses. Subjects received a single oral 800 mg dose of eslicarbazepine acetate following a standard meal in one period, and following at least 10 hours of fasting in two periods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female subjects aged between 18 and 55 years, inclusive.\n* Subjects of body mass index (BMI, kg/m2) within the normal range \\[4\\], i.e., between 18.50 and 24.99, inclusive.\n* Subjects who were healthy as determined by pre-study medical history, physical examination, vital signs, and 12-lead ECG.\n* Subjects who had clinical laboratory test results clinically acceptable at screening and admission to first treatment period.\n* Subjects who had negative tests for HBsAg, anti-HCVAb and anti- HIV-1 and HIV-2 Ab at screening.\n* Subjects who had a negative screen for alcohol and drugs of abuse at screening.\n* Subjects who were non-smokers or ex-smokers who discontinued smoking at least 3 months prior to admission.\n* Subjects who were able and willing to give written informed consent.\n* (If female) She was not of childbearing potential by reason of surgery (hysterectomy or tubal ligation) or, if of childbearing potential, she used one of the following methods of contraception: intrauterine device (by the study subject) + condom (by the partner), diaphragm (by the study subject) + condom (by the partner), or spermicide (by the study subject) + condom (by the partner).\n* (If female) She had a negative urine pregnancy test at screening and admission to each treatment period.\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 drug hypersensitivity.\n* Subjects who had a history of alcoholism or drug abuse.\n* Subjects who consumed more than 14 units of alcohol a week.\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 had previously received eslicarbazepine acetate (ESL, BIA 2-093).\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* (If female) She was pregnant or breast-feeding.\n* (If female) She was of childbearing potential and she did not used and approved effective contraceptive method or she used oral contraceptives.'}, 'identificationModule': {'nctId': 'NCT02288312', 'briefTitle': 'Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bial - Portela C S.A.'}, 'officialTitle': 'Food Effect and Dosage Form Proportionality Study of Eslicarbazepine Acetate Market Formulation in Healthy Volunteers', 'orgStudyIdInfo': {'id': 'BIA-2093-117'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BIA 2-093 800 mg fasting', 'description': 'Tablets 800 mg. Administration:Oral.', 'interventionNames': ['Drug: BIA 2-093']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 2-093 800 mg fed', 'description': 'Tablets 800 mg. Administration:Oral.', 'interventionNames': ['Drug: BIA 2-093']}, {'type': 'EXPERIMENTAL', 'label': 'BIA 2-093 400 mg', 'description': 'Tablets 2 x 400 mg. Administration:Oral.', 'interventionNames': ['Drug: BIA 2-093']}], 'interventions': [{'name': 'BIA 2-093', 'type': 'DRUG', 'otherNames': ['ESL, Eslicarbazepine acetate'], 'armGroupLabels': ['BIA 2-093 400 mg', 'BIA 2-093 800 mg fasting', 'BIA 2-093 800 mg fed']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bial - Portela C S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}