Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT02549027
Status:
COMPLETED
Last Update Posted:
2018-10-23
First Post:
2015-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C573816', 'term': 'MK-6096'}]}}, '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': '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 timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 days after the last dose of study drug (Up to approximately 42 days)', 'description': 'Analysis population is All Participants as Treated, defined as all participants who received at least one dose of study drug', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1064 50 mg', 'description': 'Single dose of 50 mg MK-1064', 'otherNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MK-1064 120 mg', 'description': 'Single dose of 120 mg MK-1064', 'otherNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK-1064 250 mg', 'description': 'Single dose of 250 mg MK-1064', 'otherNumAtRisk': 20, 'otherNumAffected': 5, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MK-6096 20 mg', 'description': 'Single dose of 20 mg MK-6096', 'otherNumAtRisk': 14, 'otherNumAffected': 3, 'seriousNumAtRisk': 14, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo', 'description': 'Single dose of placebo', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 14, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1064 50 mg', 'description': 'Single dose of 50 mg MK-1064'}, {'id': 'OG001', 'title': 'MK-1064 120 mg', 'description': 'Single dose of 120 mg MK-1064'}, {'id': 'OG002', 'title': 'MK-1064 250 mg', 'description': 'Single dose of 250 mg MK-1064'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4.27', 'groupId': 'OG000', 'lowerLimit': '2.34', 'upperLimit': '7.78'}, {'value': '3.68', 'groupId': 'OG001', 'lowerLimit': '2.01', 'upperLimit': '6.71'}, {'value': '2.67', 'groupId': 'OG002', 'lowerLimit': '1.46', 'upperLimit': '4.88'}, {'value': '17.93', 'groupId': 'OG003', 'lowerLimit': '9.82', 'upperLimit': '32.73'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.24', 'ciLowerLimit': '0.12', 'ciUpperLimit': '0.47', 'estimateComment': 'Ratio is MK-1064/placebo', 'groupDescription': 'Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% confidence interval (CI) were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.21', 'ciLowerLimit': '0.10', 'ciUpperLimit': '0.41', 'estimateComment': 'Ratio is MK-1064/placebo', 'groupDescription': 'Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.15', 'ciLowerLimit': '0.08', 'ciUpperLimit': '0.30', 'estimateComment': 'Ratio is MK-1064/placebo', 'groupDescription': 'Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing LPS was supported if the CI lies below 1 for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'LPS is measured during overnight sleep laboratory (polysomnography \\[PSG\\]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4'}, {'type': 'PRIMARY', 'title': 'LPS Following Single Doses of MK-6096 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-6096 20 mg', 'description': 'Single dose of 20 mg MK-6096'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0.87', 'groupId': 'OG000', 'lowerLimit': '0.39', 'upperLimit': '1.93'}, {'value': '17.79', 'groupId': 'OG001', 'lowerLimit': '9.21', 'upperLimit': '34.35'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.05', 'ciLowerLimit': '0.02', 'ciUpperLimit': '0.11', 'estimateComment': 'Ratio is MK-6096/placebo', 'groupDescription': 'Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for LPS treatment ratio.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1064 50 mg', 'description': 'Single dose of 50 mg MK-1064'}, {'id': 'OG001', 'title': 'MK-1064 120 mg', 'description': 'Single dose of 120 mg MK-1064'}, {'id': 'OG002', 'title': 'MK-1064 250 mg', 'description': 'Single dose of 250 mg MK-1064'}, {'id': 'OG003', 'title': 'MK-6096 20 mg', 'description': 'Single dose of 20 mg MK-6096'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after the last dose of study drug (Up to approximately 42 days)', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated - all participants who received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1064 50 mg', 'description': 'Single dose of 50 mg MK-1064'}, {'id': 'OG001', 'title': 'MK-1064 120 mg', 'description': 'Single dose of 120 mg MK-1064'}, {'id': 'OG002', 'title': 'MK-1064 250 mg', 'description': 'Single dose of 250 mg MK-1064'}, {'id': 'OG003', 'title': 'MK-6096 20 mg', 'description': 'Single dose of 20 mg MK-6096'}, {'id': 'OG004', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 14 days after the last dose of study drug (Up to approximately 42 days)', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated - all participants who received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1064 50 mg', 'description': 'Single dose of 50 mg MK-1064'}, {'id': 'OG001', 'title': 'MK-1064 120 mg', 'description': 'Single dose of 120 mg MK-1064'}, {'id': 'OG002', 'title': 'MK-1064 250 mg', 'description': 'Single dose of 250 mg MK-1064'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '22.41', 'groupId': 'OG000', 'lowerLimit': '17.69', 'upperLimit': '28.40'}, {'value': '18.01', 'groupId': 'OG001', 'lowerLimit': '14.21', 'upperLimit': '22.82'}, {'value': '19.90', 'groupId': 'OG002', 'lowerLimit': '15.70', 'upperLimit': '25.21'}, {'value': '26.41', 'groupId': 'OG003', 'lowerLimit': '20.84', 'upperLimit': '33.46'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.85', 'ciLowerLimit': '0.67', 'ciUpperLimit': '1.07', 'estimateComment': 'Ratio is MK-1064/placebo', 'groupDescription': 'Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.68', 'ciLowerLimit': '0.54', 'ciUpperLimit': '0.86', 'estimateComment': 'Ratio is MK-1064/placebo', 'groupDescription': 'Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.75', 'ciLowerLimit': '0.60', 'ciUpperLimit': '0.95', 'estimateComment': 'Ratio is MK-1064/placebo', 'groupDescription': 'Analysis used a step-down approach. Mean log treatment difference of the highest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio. If the CI lies completely below 1, testing continued to next lower MK-1064 dose. The hypothesis that MK-1064 is superior to placebo in decreasing WASO was supported if the CI lies below 1 for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4'}, {'type': 'SECONDARY', 'title': 'WASO Following Single Doses of MK-6096 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-6096 20 mg', 'description': 'Single dose of 20 mg MK-6096'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'categories': [{'measurements': [{'value': '16.65', 'groupId': 'OG000', 'lowerLimit': '12.91', 'upperLimit': '21.48'}, {'value': '26.41', 'groupId': 'OG001', 'lowerLimit': '21.17', 'upperLimit': '32.95'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.63', 'ciLowerLimit': '0.50', 'ciUpperLimit': '0.79', 'estimateComment': 'Ratio is MK-6096/placebo', 'groupDescription': 'Mean log treatment difference of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed and back-transformed to obtain the 90% CI interval for WASO treatment ratio.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.', 'unitOfMeasure': 'minutes', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1064 50 mg', 'description': 'Single dose of 50 mg MK-1064'}, {'id': 'OG001', 'title': 'MK-1064 120 mg', 'description': 'Single dose of 120 mg MK-1064'}, {'id': 'OG002', 'title': 'MK-1064 250 mg', 'description': 'Single dose of 250 mg MK-1064'}, {'id': 'OG003', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'title': 'Baseline (Pre-dose)', 'categories': [{'measurements': [{'value': '408.79', 'groupId': 'OG000', 'lowerLimit': '390.94', 'upperLimit': '426.64'}, {'value': '423.39', 'groupId': 'OG001', 'lowerLimit': '400.05', 'upperLimit': '446.72'}, {'value': '418.83', 'groupId': 'OG002', 'lowerLimit': '399.44', 'upperLimit': '438.22'}, {'value': '414.85', 'groupId': 'OG003', 'lowerLimit': '392.90', 'upperLimit': '436.79'}]}]}, {'title': 'Change at 10 hours post dose', 'categories': [{'measurements': [{'value': '17.25', 'groupId': 'OG000', 'lowerLimit': '4.41', 'upperLimit': '30.10'}, {'value': '19.94', 'groupId': 'OG001', 'lowerLimit': '7.10', 'upperLimit': '32.78'}, {'value': '21.04', 'groupId': 'OG002', 'lowerLimit': '8.20', 'upperLimit': '33.88'}, {'value': '14.66', 'groupId': 'OG003', 'lowerLimit': '1.82', 'upperLimit': '27.50'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '2.59', 'ciLowerLimit': '-12.01', 'ciUpperLimit': '17.20', 'estimateComment': 'Difference is MK-1064 - placebo', 'groupDescription': 'Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG001', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '5.28', 'ciLowerLimit': '-9.33', 'ciUpperLimit': '19.88', 'estimateComment': 'Difference is MK-1064 - placebo', 'groupDescription': 'Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '6.38', 'ciLowerLimit': '-8.23', 'ciUpperLimit': '20.98', 'estimateComment': 'Difference is MK-1064 - placebo', 'groupDescription': 'Analysis used a step-up approach. Mean treatment difference in change from baseline of the lowest MK-1064 dose versus placebo (MK-1064 - placebo) and 90% CI were computed. If the CI lies completely below 25 milliseconds, testing continued to the next higher MK-1064 dose. The hypothesis that at least one dose of MK-1064 does not produce psychomotor impairment versus placebo as assessed by CRT will be supported if the CI lies below 25 milliseconds for at least one dose.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 10 hours post dose, within each treatment period', 'description': 'CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.', 'unitOfMeasure': 'milliseconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol. Note: Data included are those obtained from subjects during administration of MK-1064 doses in Period 1-4 and during administration of placebo in Period 1-4'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-6096 20 mg', 'description': 'Single dose of 20 mg MK-6096'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Single dose of placebo'}], 'classes': [{'title': 'Baseline (Pre-dose)', 'categories': [{'measurements': [{'value': '425.94', 'groupId': 'OG000', 'lowerLimit': '391.76', 'upperLimit': '460.12'}, {'value': '417.81', 'groupId': 'OG001', 'lowerLimit': '396.11', 'upperLimit': '439.51'}]}]}, {'title': 'Change at 10 hours post dose', 'categories': [{'measurements': [{'value': '24.04', 'groupId': 'OG000', 'lowerLimit': '8.04', 'upperLimit': '40.04'}, {'value': '14.74', 'groupId': 'OG001', 'lowerLimit': '1.49', 'upperLimit': '27.99'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '9.30', 'ciLowerLimit': '-7.10', 'ciUpperLimit': '25.70', 'estimateComment': 'Difference is MK-6096 - placebo', 'groupDescription': 'Mean treatment difference in change from baseline of MK-6096 versus placebo (MK-6096 - placebo) and 90% CI were computed.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 10 hours post dose, within each treatment period', 'description': 'CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.', 'unitOfMeasure': 'milliseconds', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol. Note: Data included are those obtained from subjects during MK-6096 dose in Period 5 and during administration of placebo in any period. 1 subject took placebo within Periods 1-4 and also in Period 5. Data for both administrations of placebo are included (i.e., for placebo, analysis includes 21 observations from 20 subjects)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-1064: 50 mg→250 mg→Placebo→120 mg (Period 1-4)', 'description': 'Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064.'}, {'id': 'FG001', 'title': 'MK-1064: Placebo→50 mg→120 mg→250 mg (Period 1-4)', 'description': 'Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064.'}, {'id': 'FG002', 'title': 'MK-1064: 120 mg→Placebo→250 mg→50 mg (Period 1-4)', 'description': 'Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064.'}, {'id': 'FG003', 'title': 'MK-1064: 250 mg→120 mg→50 mg→Placebo (Period 1-4)', 'description': 'Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo.'}, {'id': 'FG004', 'title': 'MK-6096 20 mg (Period 5)', 'description': 'Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of 20 mg of MK-6096 in Period 5.'}, {'id': 'FG005', 'title': 'Placebo (Period 5)', 'description': 'Participants in this arm had completed the first 4 study periods, and were randomized to receive a single dose of placebo in Period 5.'}], 'periods': [{'title': 'Period 1 - MK-1064 or Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout After Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 2 - MK-1064 or Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout After Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 3 - MK-1064 or Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout After Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 4 - MK-1064 or Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Washout After Period 4', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Period 5 - MK-6096 or Placebo', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'In Period 5, participants previously in this arm appear in MK-6096 20 mg/Placebo (Period 5) arms', 'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'In Period 5, participants previously in this arm appear in MK-6096 20 mg (Period 5) arm', 'groupId': 'FG001', 'numSubjects': '0'}, {'comment': 'In Period 5, participants previously in this arm appear in MK-6096 20 mg (Period 5) arm', 'groupId': 'FG002', 'numSubjects': '0'}, {'comment': 'In Period 5, participants previously in this arm appear in MK-6096 20 mg (Period 5) arm', 'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'Participants entering Period 5 were previously in MK-1064/Placebo (Period 1-4) arms', 'groupId': 'FG004', 'numSubjects': '16'}, {'comment': 'Participants entering Period 5 were previously in MK-1064/Placebo (Period 1-4) arms', 'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'comment': 'The 2 participants who did not complete Period 5 did not receive study drug in Period 5', 'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants were randomized to 1 of 4 treatment sequences of single doses of MK-1064 or placebo, administered over 4 study periods in a crossover design; then in Period 5 participants received, according to separate randomization, either a single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Study Participants'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '4.60', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '38'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], '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': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2010-04-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-24', 'studyFirstSubmitDate': '2015-09-11', 'resultsFirstSubmitDate': '2015-11-04', 'studyFirstSubmitQcDate': '2015-09-11', 'lastUpdatePostDateStruct': {'date': '2018-10-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-11-04', 'studyFirstPostDateStruct': {'date': '2015-09-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Latency to Persistent Sleep (LPS) Following Single Doses of MK-1064 and Placebo', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'LPS is measured during overnight sleep laboratory (polysomnography \\[PSG\\]) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.'}, {'measure': 'LPS Following Single Doses of MK-6096 and Placebo', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'LPS is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of time from the beginning of PSG assessment to the first interval of 10 consecutive minutes of sleep.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Up to 14 days after the last dose of study drug (Up to approximately 42 days)', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.'}, {'measure': 'Number of Participants Who Discontinued Study Due to an AE', 'timeFrame': 'Up to 14 days after the last dose of study drug (Up to approximately 42 days)', 'description': 'An AE is defined as any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the study drug, whether or not considered related to the use of the study drug. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition which is temporally associated with the use of the study drug, is also an AE.'}], 'secondaryOutcomes': [{'measure': 'Wake Time After Sleep Onset (WASO) Following Single Doses of MK-1064 and Placebo', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.'}, {'measure': 'WASO Following Single Doses of MK-6096 and Placebo', 'timeFrame': '1 to 9 hours post dose, within each treatment period', 'description': 'WASO is measured during overnight sleep laboratory (PSG) assessment and is defined as the duration of wakefulness from the onset of persistent sleep (i.e., 10 consecutive minutes of sleep) to the end of PSG assessment the following morning.'}, {'measure': 'Change From Baseline in Choice Reaction Time (CRT) Following Single Doses of MK-1064 and Placebo', 'timeFrame': 'Pre-dose and 10 hours post dose, within each treatment period', 'description': 'CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.'}, {'measure': 'Change From Baseline in CRT Following Single Doses of MK-6096 and Placebo', 'timeFrame': 'Pre-dose and 10 hours post dose, within each treatment period', 'description': 'CRT assessment used in this study is a two-choice, computer-controlled test in which the participant responds to stimulus words presented on the screen of a laptop computer. During the test either the word "NO" or the word "YES" is presented on the screen and the participant is instructed to press the corresponding button as quickly as possible. There are 50 trials for which each stimulus word is chosen randomly with equal probability and there is a varying inter-stimulus interval. The mean reaction time of accurate responses is determined. The assessment is performed pre-dose and at 10 hours post dose. The outcome measure is change from baseline to post dose in reaction time.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Polysomnography']}, 'referencesModule': {'availIpds': [{'url': 'http://www.merck.com/clinical-trials/study.html?id=1064-003&kw=1064-003&tab=access', 'type': 'CSR Synopsis'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized, double-blind, placebo-controlled, 5-period crossover study is to assess the effect of single oral doses of MK-1064 on latency to persistent sleep (LPS) as measured by polysomnography (PSG) in healthy young male participants, and to evaluate the safety and tolerability of single oral doses of MK-1064 and MK-6096 in healthy young male participants. The primary efficacy hypothesis is that at least one dose of MK-1064 is superior to placebo in decreasing LPS in healthy male participants as assessed by PSG.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) ≤31 kg/m\\^2\n* In good health based on medical history, physical examination, vital sign measurements, and laboratory safety tests\n* Nonsmoker and has not used nicotine or nicotine-containing products for at least 6 months\n* No history of any sleep disorder\n* Has not used prescription or over the counter sedation or alerting medication in 4 weeks prior to screening\n* Participant has a usual bedtime between 8:00 PM and 12:00 AM\n* Participant has total sleep duration of ≥6.5 and ≤9 hours during the 4 weeks prior to screening\n* Male participants with female partner(s) of child-bearing potential must agree to use a medically acceptable method of contraception during the study and for 90 days after the last dose of study drug\n\nExclusion Criteria:\n\n* Mentally or legally incapacitated, significant emotional problems at screening or expected during the conduct of the study or history of a clinically significant psychiatric disorder within the last 10 years\n* History of any persistent sleep abnormality (including difficulty falling asleep, difficulty staying asleep) lasting for 3 months or more, or history of obstructive sleep apnea, restless leg syndrome, or narcolepsy\n* History of clinically significant sleep disorders within the last 5 years\n* History of circadian rhythm sleep disorder, clinically important parasomnia, or primary insomnia\n* History of repeated falls or fractures secondary to falling within the past 2 years\n* Participant works a night shift and is not able to avoid night shift work a minimum of 1 week prior to screening and for the duration of the study\n* Participant has traveled across 3 or more time zones (transmeridian travel) in the last 2 weeks prior to study\n* Is a regular user of sedative-hypnotic agents\n* History of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases\n* History of stroke, peripheral neuropathy, chronic seizures or other clinically significant neurological disorder or cognitive impairment\n* History of cancer\n* History of cataplexy\n* Participant is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies, beginning approximately 2 weeks prior to administration of the initial dose of study drug and throughout the study\n* Participant consumes \\>3 servings of alcohol a day\n* Participant consumes \\>6 caffeine servings a day\n* Participant has had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to screening, or participated in another investigational study within 3 months prior to first dose of study drug\n* History of significant multiple and/or severe allergies or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food\n* Is currently a regular user of any illicit drugs or has a history of drug (including alcohol) abuse within 2 years of screening'}, 'identificationModule': {'nctId': 'NCT02549027', 'briefTitle': 'A Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG) (MK-1064-003)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Crossover Study to Evaluate the Effects of Single Doses of MK-1064 and MK-6096 on Polysomnography (PSG)', 'orgStudyIdInfo': {'id': '1064-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg', 'description': 'For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 50 mg MK-1064, Period 2 - single dose of 250 mg MK-1064, Period 3 - single dose of placebo, Period 4 - single dose of 120 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.', 'interventionNames': ['Drug: MK-1064', 'Drug: MK-6096', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg', 'description': 'For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of placebo, Period 2 - single dose of 50 mg MK-1064, Period 3 - single dose of 120 mg MK-1064, Period 4 - single dose of 250 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.', 'interventionNames': ['Drug: MK-1064', 'Drug: MK-6096', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg', 'description': 'For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 120 mg MK-1064, Period 2 - single dose of placebo, Period 3 - single dose of 250 mg MK-1064, Period 4 - single dose of 50 mg MK-1064. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.', 'interventionNames': ['Drug: MK-1064', 'Drug: MK-6096', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo', 'description': 'For overall study population, 5 participants each were to be allocated to one of 4 sequences. In this sequence, participants received the following: Period 1 - single dose of 250 mg MK-1064, Period 2 - single dose of 120 mg MK-1064, Period 3 - single dose of 50 mg MK-1064, Period 4 - single dose of placebo. Participants completing the first 4 periods also were to receive the following: Period 5 - single dose of 20 mg MK-6096 or placebo, in an 18:2 ratio for overall study population, according to separate allocation. There was a minimum 7-day washout between doses.', 'interventionNames': ['Drug: MK-1064', 'Drug: MK-6096', 'Drug: Placebo']}], 'interventions': [{'name': 'MK-1064', 'type': 'DRUG', 'description': 'Oral MK-1064 tablets (10 and 50 mg strengths)', 'armGroupLabels': ['Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg', 'Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo', 'Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg', 'Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg']}, {'name': 'MK-6096', 'type': 'DRUG', 'description': 'Oral MK-6096 tablets (5 mg strength)', 'armGroupLabels': ['Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg', 'Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo', 'Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg', 'Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)', 'armGroupLabels': ['Sequence (MK-1064): 120 mg→Placebo→250 mg→50 mg', 'Sequence (MK-1064): 250 mg→120 mg→50 mg→Placebo', 'Sequence (MK-1064): 50 mg→250 mg→Placebo→120 mg', 'Sequence (MK-1064): Placebo→50 mg→120 mg→250 mg']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}