Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-29 @ 5:19 PM
Study NCT ID:
NCT00972595
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2009-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014839', 'term': 'Vomiting'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D002227', 'term': 'Carbazoles'}, {'id': 'D007211', 'term': 'Indoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006575', 'term': 'Heterocyclic Compounds, 3-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events (AEs) were captured from Treatment Period 1, Day 1 to 14 days Post Last Dose of Study Drug in Treatment Period 2, including the 7 day washout in between periods', 'eventGroups': [{'id': 'EG000', 'title': 'OE U.K. Tablet Then U.K. Tablet', 'description': 'Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally', 'otherNumAtRisk': 45, 'otherNumAffected': 13, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'U.K. Tablet Then OE U.K. Tablet', 'description': 'U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally', 'otherNumAtRisk': 44, 'otherNumAffected': 6, 'seriousNumAtRisk': 22, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Haematocrit Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Haemoglobin Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Sinus Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Proteinuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pharyngolaryngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'seriousEvents': [{'term': 'Aborted Pregnancy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 23, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 7.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OE U.K. Tablet', 'description': 'Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally'}, {'id': 'OG001', 'title': 'U.K. Tablet', 'description': 'Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '257.8', 'spread': '106.8', 'groupId': 'OG000'}, {'value': '262.6', 'spread': '105.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Ratio', 'ciPctValue': '90', 'paramValue': '0.98', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.03', 'groupDescription': 'Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8-mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose', 'unitOfMeasure': 'ng*hr/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 44 of the subjects who completed both Treatments OE U.K. tablet and U.K. tablet were included in the statistical analysis.'}, {'type': 'PRIMARY', 'title': 'Peak Plasma Concentration (Cmax) for Ondansetron', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'OE U.K. Tablet', 'description': 'Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally'}, {'id': 'OG001', 'title': 'U.K. Tablet', 'description': 'Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally'}], 'classes': [{'categories': [{'measurements': [{'value': '41.3', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '41.8', 'spread': '13.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Least-Squares Mean Ratio', 'ciPctValue': '90', 'paramValue': '0.99', 'ciLowerLimit': '0.93', 'ciUpperLimit': '1.05', 'groupDescription': 'Least-Squares Mean Ratio (OE U.K. tablet / U.K. tablet): an over-encapsulated single 8 mg tablet of United Kingdom\n\n(U.K.) ZOFRAN™ (ondansetron) taken orally; a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the\n\nUnited Kingdom (U.K.) taken orally', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'testedNonInferiority': True, 'nonInferiorityComment': 'Study Primary Hypothesis: A single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet over-encapsulated is bioequivalent to a single dose of the U.K. ZOFRAN™ (ondansetron) 8 mg tablet. That is, the true geometric mean ratios (U.K. ZOFRAN™ tablet over-encapsulated/U.K. ZOFRAN™ tablet) of AUC0-∞ and Cmax for ondansetron each lie within the interval 0.80 to 1.25.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 hours post-dose', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All 44 of the subjects who completed both Treatment OE U.K. tablet and U.K. tablet were included in the statistical analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OE U.K. Tablet Then U.K. Tablet', 'description': 'Over-encapsulated (OE) United Kingdom (U.K.) tablet then U.K. tablet: Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally/Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally'}, {'id': 'FG001', 'title': 'U.K. Tablet Then OE U.K. Tablet', 'description': 'U.K. tablet then OE U.K. tablet: Treatment U.K. tablet: a single 8 mg tablet of ZOFRAN™ (ondansetron) which is marketed in the United Kingdom (U.K.) taken orally/Treatment OE U.K. tablet: an over-encapsulated single 8 mg tablet of United Kingdom (U.K.) ZOFRAN™ (ondansetron) taken orally'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'All Randomized Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000', 'lowerLimit': '18', 'upperLimit': '54'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '170.8', 'groupId': 'BG000', 'lowerLimit': '154.9', 'upperLimit': '188.0'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Centimeters', 'dispersionType': 'FULL_RANGE'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '72.0', 'groupId': 'BG000', 'lowerLimit': '45.5', 'upperLimit': '102.7'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Killograms', 'dispersionType': 'FULL_RANGE'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2004-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-18', 'studyFirstSubmitDate': '2009-09-03', 'resultsFirstSubmitDate': '2010-05-19', 'studyFirstSubmitQcDate': '2009-09-04', 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-05-19', 'studyFirstPostDateStruct': {'date': '2009-09-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2010-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plasma Area Under The Concentration Versus Time Curve (AUC(0-infinity)) For Ondansetron', 'timeFrame': '0 (predose), 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 18, and 24 hours postdose'}, {'measure': 'Peak Plasma Concentration (Cmax) for Ondansetron', 'timeFrame': '24 hours post-dose'}]}, 'conditionsModule': {'conditions': ['Chemotherapy-Induced Nausea and Vomiting']}, 'descriptionModule': {'briefSummary': 'This study will assess the bioequivalence of a Merck clinical trial formulation of ondansetron compared to a non-U.S. marketed formulation of ondansetron.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* If female, subject is not pregnant or breast-feeding\n* Subject has been a nonsmoker for at least 6 months\n* Subject is in good health\n\nExclusion Criteria:\n\n* Subject has a history of high blood pressure, asthma, other pulmonary disease, Gastrointestinal (GI) abnormalities/peptic ulcers, or cardiovascular, liver, neurologic, or kidney disease\n* Subject is a habitual and heavy consumer of caffeine'}, 'identificationModule': {'nctId': 'NCT00972595', 'briefTitle': 'Bioequivalence of Two Formulations of Ondansetron in Healthy Adults (0869-106)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'An Open-Label, Randomized, Single-Dose, 2-Period Crossover Study to Determine the Bioequivalence of 2 Formulations of Ondansetron in Healthy Young Adult Male and Female Subjects', 'orgStudyIdInfo': {'id': '0869-106'}, 'secondaryIdInfos': [{'id': 'MK0869-106'}, {'id': '2009_657'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'clinical trial formulation', 'interventionNames': ['Drug: ondansetron clinical trial formulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'B', 'description': 'non-U.S. marketed formulation', 'interventionNames': ['Drug: ondansetron marketed formulation']}], 'interventions': [{'name': 'ondansetron clinical trial formulation', 'type': 'DRUG', 'otherNames': ['ZOFRAN™'], 'description': 'Single dose of an over-encapsulated 8 mg tablet of United Kingdom (U.K.) ondansetron (ZOFRAN™) in one of two treatment periods.', 'armGroupLabels': ['A']}, {'name': 'ondansetron marketed formulation', 'type': 'DRUG', 'otherNames': ['ZOFRAN™'], 'description': 'Single dose of an 8 mg tablet of U.K. ondansetron (ZOFRAN™) in one of two treatment periods.', 'armGroupLabels': ['B']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}