Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-28 @ 11:29 PM
Study NCT ID:
NCT01111851
Status:
COMPLETED
Last Update Posted:
2015-02-25
First Post:
2010-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, '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': 'C579707', 'term': 'fosaprepitant'}, {'id': 'D000077608', 'term': 'Aprepitant'}, {'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D017294', 'term': 'Ondansetron'}], 'ancestors': [{'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'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', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The SPONSOR must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the SPONSOR as confidential must be deleted prior to submission. SPONSOR review can be expedited to meet publication guidelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.', 'otherNumAtRisk': 8, 'otherNumAffected': 5, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.', 'otherNumAtRisk': 8, 'otherNumAffected': 8, 'seriousNumAtRisk': 8, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Visual impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Influenza like illness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Neutrophil count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Positron emission tomogram abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hiccups', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Acne', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Flushing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 8, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain NK1-receptor Occupancy at 24 Hours Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'OG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.40', 'groupId': 'OG000', 'lowerLimit': '99.51', 'upperLimit': '101.29'}, {'value': '100.20', 'groupId': 'OG001', 'lowerLimit': '99.31', 'upperLimit': '101.09'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio of the LS Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.01', 'estimateComment': 'The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \\[aprepitant\n\n165 mg/fosaprepitant 150 mg\\].', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '24 hours post dose', 'unitOfMeasure': 'Percent of occupancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least 1 successful post dose PET\n\nscan were included in the analysis population.'}, {'type': 'PRIMARY', 'title': 'Brain NK1-receptor Occupancy at 48 Hours Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'OG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '98.62', 'groupId': 'OG000', 'lowerLimit': '96.91', 'upperLimit': '100.37'}, {'value': '98.79', 'groupId': 'OG001', 'lowerLimit': '97.19', 'upperLimit': '100.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio of the LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '0.98', 'ciUpperLimit': '1.02', 'estimateComment': 'The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \\[aprepitant\n\n165 mg/fosaprepitant 150 mg\\].', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '48 hours post dose', 'unitOfMeasure': 'Percent of occupancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least 1 successful postdose PET\n\nscan were included in the analysis population.'}, {'type': 'SECONDARY', 'title': 'Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'OG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '100.25', 'groupId': 'OG000', 'lowerLimit': '97.22', 'upperLimit': '103.39'}, {'value': '99.99', 'groupId': 'OG001', 'lowerLimit': '97.47', 'upperLimit': '102.58'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio of the LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.00', 'ciLowerLimit': '0.97', 'ciUpperLimit': '1.03', 'estimateComment': 'The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \\[aprepitant\n\n165 mg/fosaprepitant 150 mg\\].', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant', 'unitOfMeasure': 'Percent of occupancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least 1 successful postdose PET\n\nscan were included in the analysis population.'}, {'type': 'SECONDARY', 'title': 'Brain NK1-receptor Occupancy at 120 Hours Post Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'OG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.93', 'groupId': 'OG000', 'lowerLimit': '34.37', 'upperLimit': '104.49'}, {'value': '54.32', 'groupId': 'OG001', 'lowerLimit': '31.15', 'upperLimit': '94.71'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio of the LS means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.91', 'ciLowerLimit': '0.50', 'ciUpperLimit': '1.66', 'estimateComment': 'The point estimate and 90% confidence interval (CI) were generated for the geometric mean ratio (GMR) \\[aprepitant\n\n165 mg/fosaprepitant 150 mg\\].', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '120 hours post dose', 'unitOfMeasure': 'Percent of occupancy', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants with at least 1 successful postdose PET\n\nscan were included in the analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'FG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'All planned PET scans were not obtained.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Aprepitant 250 mg was not evaluated because the assessment of the positron emission tomography (PET) scan data (neurokinin 1 (NK1)-receptor occupancy values at 24 \\& 48 hours postdose) from fosaprepitant 150 mg \\& aprepitant 165 mg revealed that the protocol's hypothesis was met; therefore, it was not necessary to evaluate aprepitant 250 mg."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Fosaprepitant 150 mg', 'description': 'A single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes, 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'BG001', 'title': 'Aprepitant 165 mg', 'description': 'A single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '< = 18 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Between 18 and 55 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': '> = 55 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', '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': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Belgium', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-06', 'studyFirstSubmitDate': '2010-04-26', 'resultsFirstSubmitDate': '2011-09-29', 'studyFirstSubmitQcDate': '2010-04-26', 'lastUpdatePostDateStruct': {'date': '2015-02-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-09-29', 'studyFirstPostDateStruct': {'date': '2010-04-28', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-11-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain NK1-receptor Occupancy at 24 Hours Post Dose', 'timeFrame': '24 hours post dose'}, {'measure': 'Brain NK1-receptor Occupancy at 48 Hours Post Dose', 'timeFrame': '48 hours post dose'}], 'secondaryOutcomes': [{'measure': 'Brain NK1-receptor Occupancy at the Time of the Maximum Concentration (Tmax)', 'timeFrame': '30 minutes after the end of the 20-minute infusion of fosaprepitant or at 4 hours after oral dosing of aprepitant'}, {'measure': 'Brain NK1-receptor Occupancy at 120 Hours Post Dose', 'timeFrame': '120 hours post dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['NK1-receptor occupancy'], 'conditions': ['Chemotherapy-Induced Nausea and Vomiting (CINV)']}, 'referencesModule': {'references': [{'pmid': '22739139', 'type': 'RESULT', 'citation': 'Van Laere K, De Hoon J, Bormans G, Koole M, Derdelinckx I, De Lepeleire I, Declercq R, Sanabria Bohorquez SM, Hamill T, Mozley PD, Tatosian D, Xie W, Liu Y, Liu F, Zappacosta P, Mahon C, Butterfield KL, Rosen LB, Murphy MG, Hargreaves RJ, Wagner JA, Shadle CR. Equivalent dynamic human brain NK1-receptor occupancy following single-dose i.v. fosaprepitant vs. oral aprepitant as assessed by PET imaging. Clin Pharmacol Ther. 2012 Aug;92(2):243-50. doi: 10.1038/clpt.2012.62. Epub 2012 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate if the mean value of brain neurokinin 1 (NK1)-receptor occupancy of participants treated with aprepitant is similar to that of participants treated with fosaprepitant at certain timepoints.', 'detailedDescription': 'The third arm of the study (Aprepitant 250 mg) will only be conducted if the real-time assessment of the NK1-receptor occupancy data between fosaprepitant 150 mg \\& aprepitant 165 mg reveals that the primary hypothesis will not be supported.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy\n* Female participants must be of non-childbearing potential\n* Non-smoker or has not used nicotine or nicotine-containing products for at least 6 months\n\nExclusion Criteria:\n\n* History of a clinically significant psychiatric disorder over the last 5 to 10 years\n* History of stroke, chronic seizures, or major neurological disorder\n* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases\n* History of neoplastic disease\n* Excessive consumption of alcohol (3 drinks/day) or caffeinated beverages (6 servings/day)\n* Major surgery, donated or lost 1 unit of blood within 4 weeks\n* Participated in another investigational study within 4 weeks\n* History of significant drug allergy or any clinically significant adverse\n\nexperiences related to EMEND™, dexamethasone, or ondansetron\n\n* History of significant multiple and/or severe allergies\n* History of anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n* Current drug/alcohol abuse, or history of such within 2 years\n* Participation in a PET study or other study involving administration of a radioactive substance or ionizing radiation within the prior 12 months\n* Extensive radiological examination within the prior 12 months\n* Magnetizable metal prostheses or devices (Magnetic Resonance Imaging (MRI) hazard)\n* History of claustrophobia'}, 'identificationModule': {'nctId': 'NCT01111851', 'briefTitle': 'Aprepitant and Fosaprepitant Time-on-Target PET (Positron Emission Tomography) Study (0869-183)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'MK0869 and MK0517 Time-on-Target PET Study', 'orgStudyIdInfo': {'id': '0869-183'}, 'secondaryIdInfos': [{'id': '2010_531'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fosaprepitant 150 mg', 'description': 'Fosaprepitant 150 mg', 'interventionNames': ['Drug: Fosaprepitant 150 mg', 'Drug: Dexamethasone (12-8-16-16 mg)', 'Drug: Ondansetron', 'Drug: MK0999']}, {'type': 'EXPERIMENTAL', 'label': 'Aprepitant 165 mg', 'description': 'Aprepitant 165 mg', 'interventionNames': ['Drug: Aprepitant 165 mg', 'Drug: Dexamethasone (12-8-16-16 mg)', 'Drug: Ondansetron', 'Drug: MK0999']}, {'type': 'EXPERIMENTAL', 'label': 'Aprepitant 250 mg', 'description': 'Aprepitant 250 mg', 'interventionNames': ['Drug: Aprepitant 250 mg', 'Drug: Dexamethasone (12-8-8-16 mg)', 'Drug: Ondansetron', 'Drug: MK0999']}], 'interventions': [{'name': 'Fosaprepitant 150 mg', 'type': 'DRUG', 'otherNames': ['MK0517'], 'description': 'a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal', 'armGroupLabels': ['Fosaprepitant 150 mg']}, {'name': 'Aprepitant 165 mg', 'type': 'DRUG', 'otherNames': ['MK0869'], 'description': 'a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal', 'armGroupLabels': ['Aprepitant 165 mg']}, {'name': 'Aprepitant 250 mg', 'type': 'DRUG', 'otherNames': ['MK0869'], 'description': 'a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal', 'armGroupLabels': ['Aprepitant 250 mg']}, {'name': 'Dexamethasone (12-8-16-16 mg)', 'type': 'DRUG', 'otherNames': ['Dexamethasone'], 'description': 'Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal.', 'armGroupLabels': ['Aprepitant 165 mg', 'Fosaprepitant 150 mg']}, {'name': 'Dexamethasone (12-8-8-16 mg)', 'type': 'DRUG', 'otherNames': ['Dexamethasone'], 'description': 'Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal.', 'armGroupLabels': ['Aprepitant 250 mg']}, {'name': 'Ondansetron', 'type': 'DRUG', 'description': 'The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion', 'armGroupLabels': ['Aprepitant 165 mg', 'Aprepitant 250 mg', 'Fosaprepitant 150 mg']}, {'name': 'MK0999', 'type': 'DRUG', 'description': 'I.V. infusion of MK0999 containing \\~100 MBq (\\~3 mCi) containing ≤ 5 ug of MK0999)', 'armGroupLabels': ['Aprepitant 165 mg', 'Aprepitant 250 mg', 'Fosaprepitant 150 mg']}]}, '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'}}}}