Viewing Study NCT00791661

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Ignite Creation Date: 2025-12-24 @ 12:24 PM
Ignite Modification Date: 2025-12-29 @ 3:34 PM
Study NCT ID: NCT00791661
Status: COMPLETED
Last Update Posted: 2016-01-07
First Post: 2008-11-10
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Japan']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The same participant may appear in more than one treatment arm.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg', 'otherNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg', 'otherNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Placebo', 'description': 'Participants received matching placebo to MK-1006', 'otherNumAtRisk': 15, 'otherNumAffected': 1, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG010', 'title': 'Placebo Fed', 'description': 'Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast', 'otherNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Periodontitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'sourceVocabulary': 'MedDRA 11.0'}, {'term': 'Blood triglycerides increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 5, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 2, 'numAffected': 0}], 'organSystem': 'Investigations', 'sourceVocabulary': 'MedDRA 11.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Who Experienced at Least One Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}, {'id': 'OG009', 'title': 'Placebo', 'description': 'Participants received matching placebo to MK-1006'}, {'id': 'OG010', 'title': 'Placebo Fed', 'description': 'Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '3', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '1', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}, {'value': '1', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)', 'description': 'An adverse event 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 product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received study drug. The same participant may appear in more than one treatment arm.'}, {'type': 'SECONDARY', 'title': 'Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '489', 'spread': '134', 'groupId': 'OG000'}, {'value': '904', 'spread': '249', 'groupId': 'OG001'}, {'value': '1900', 'spread': '384', 'groupId': 'OG002'}, {'value': '2350', 'spread': '897', 'groupId': 'OG003'}, {'value': '2100', 'spread': '556', 'groupId': 'OG004'}, {'value': '3820', 'spread': '1300', 'groupId': 'OG005'}, {'value': '6060', 'spread': '2180', 'groupId': 'OG006'}, {'value': '6920', 'spread': '1420', 'groupId': 'OG007'}, {'value': '9560', 'spread': '3490', 'groupId': 'OG008'}]}]}], 'analyses': [{'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric mean ratio (fed/fasted)', 'ciPctValue': '95', 'paramValue': '0.92', 'statisticalMethod': 'Mixed-effect model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.'}, {'type': 'SECONDARY', 'title': 'Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '358', 'spread': '116', 'groupId': 'OG000'}, {'value': '665', 'spread': '186', 'groupId': 'OG001'}, {'value': '1450', 'spread': '315', 'groupId': 'OG002'}, {'value': '1720', 'spread': '782', 'groupId': 'OG003'}, {'value': '1440', 'spread': '342', 'groupId': 'OG004'}, {'value': '2790', 'spread': '1000', 'groupId': 'OG005'}, {'value': '4610', 'spread': '1730', 'groupId': 'OG006'}, {'value': '5370', 'spread': '1330', 'groupId': 'OG007'}, {'value': '7540', 'spread': '3010', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.', 'unitOfMeasure': 'nM*hr', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.'}, {'type': 'SECONDARY', 'title': 'Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'spread': '16.3', 'groupId': 'OG000'}, {'value': '75.4', 'spread': '23.9', 'groupId': 'OG001'}, {'value': '169', 'spread': '49.8', 'groupId': 'OG002'}, {'value': '185', 'spread': '102', 'groupId': 'OG003'}, {'value': '141', 'spread': '41', 'groupId': 'OG004'}, {'value': '310', 'spread': '172', 'groupId': 'OG005'}, {'value': '514', 'spread': '180', 'groupId': 'OG006'}, {'value': '628', 'spread': '205', 'groupId': 'OG007'}, {'value': '912', 'spread': '371', 'groupId': 'OG008'}]}]}], 'analyses': [{'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric mean ratio (fed/fasted)', 'ciPctValue': '95', 'paramValue': '0.81', 'statisticalMethod': 'Mixed-effect model', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'The placebo group was not evaluated for this outcome measure.', 'unitOfMeasure': 'nM', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.'}, {'type': 'SECONDARY', 'title': 'Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '3.0', 'groupId': 'OG000', 'lowerLimit': '2.0', 'upperLimit': '5.0'}, {'value': '4.0', 'groupId': 'OG001', 'lowerLimit': '3.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG002', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG003', 'lowerLimit': '1.0', 'upperLimit': '5.0'}, {'value': '5.0', 'groupId': 'OG004', 'lowerLimit': '3.0', 'upperLimit': '6.0'}, {'value': '4.0', 'groupId': 'OG005', 'lowerLimit': '1.0', 'upperLimit': '4.0'}, {'value': '3.5', 'groupId': 'OG006', 'lowerLimit': '1.0', 'upperLimit': '6.0'}, {'value': '5.0', 'groupId': 'OG007', 'lowerLimit': '5.0', 'upperLimit': '5.0'}, {'value': '3.0', 'groupId': 'OG008', 'lowerLimit': '1.0', 'upperLimit': '5.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'The placebo group was not evaluated for this outcome measure.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.'}, {'type': 'SECONDARY', 'title': 'Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}], 'classes': [{'categories': [{'measurements': [{'value': '18.0', 'spread': '5.5', 'groupId': 'OG000'}, {'value': '18.5', 'spread': '3.8', 'groupId': 'OG001'}, {'value': '19.1', 'spread': '2.2', 'groupId': 'OG002'}, {'value': '18.5', 'spread': '3.5', 'groupId': 'OG003'}, {'value': '17.0', 'spread': '1.7', 'groupId': 'OG004'}, {'value': '21.2', 'spread': '2.9', 'groupId': 'OG005'}, {'value': '22.1', 'spread': '5.2', 'groupId': 'OG006'}, {'value': '20.7', 'spread': '2.6', 'groupId': 'OG007'}, {'value': '21.5', 'spread': '4.0', 'groupId': 'OG008'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Discontinued Treatment Due to an Adverse Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}, {'id': 'OG009', 'title': 'Placebo', 'description': 'Participants received matching placebo to MK-1006'}, {'id': 'OG010', 'title': 'Placebo Fed', 'description': 'Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '0', 'groupId': 'OG009'}, {'value': '0', 'groupId': 'OG010'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'up to approximately 17 days', 'description': 'An adverse event 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 product.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who received study drug. The same participant may appear in more than one treatment arm.'}, {'type': 'SECONDARY', 'title': '24-hour Weighted Mean Glucose (WMG) Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '4', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '15', 'groupId': 'OG009'}, {'value': '2', 'groupId': 'OG010'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1006 15 mg', 'description': 'Participants received a single dose of MK-1006 15 mg'}, {'id': 'OG001', 'title': 'MK-1006 30 mg', 'description': 'Participants received a single dose of MK-1006 30 mg'}, {'id': 'OG002', 'title': 'MK-1006 45 mg', 'description': 'Participants received a single dose of MK-1006 45 mg'}, {'id': 'OG003', 'title': 'MK-1006 60 mg', 'description': 'Participants received a single dose of MK-1006 60 mg'}, {'id': 'OG004', 'title': 'MK-1006 60 mg Fed', 'description': 'Participants received a single dose of MK-1006 60 mg following consumption of a standard Japanese breakfast'}, {'id': 'OG005', 'title': 'MK-1006 80 mg', 'description': 'Participants received a single dose of MK-1006 80 mg'}, {'id': 'OG006', 'title': 'MK-1006 100 mg', 'description': 'Participants received a single dose of MK-1006 100 mg'}, {'id': 'OG007', 'title': 'MK-1006 140 mg', 'description': 'Participants received a single dose of MK-1006 140 mg'}, {'id': 'OG008', 'title': 'MK-1006 170 mg', 'description': 'Participants received a single dose of MK-1006 170 mg'}, {'id': 'OG009', 'title': 'Placebo', 'description': 'Participants received matching placebo to MK-1006'}, {'id': 'OG010', 'title': 'Placebo Fed', 'description': 'Participants received matching placebo to MK-1006 following consumption of a standard Japanese breakfast'}], 'classes': [{'categories': [{'measurements': [{'value': '206.2', 'spread': '50.8', 'groupId': 'OG000', 'lowerLimit': '188.0', 'upperLimit': '224.4'}, {'value': '197.6', 'spread': '40.9', 'groupId': 'OG001', 'lowerLimit': '179.1', 'upperLimit': '216.1'}, {'value': '188.6', 'spread': '28.0', 'groupId': 'OG002', 'lowerLimit': '170.3', 'upperLimit': '206.9'}, {'value': '178.0', 'spread': '24.7', 'groupId': 'OG003', 'lowerLimit': '159.5', 'upperLimit': '196.6'}, {'value': '165.7', 'spread': '26.7', 'groupId': 'OG004', 'lowerLimit': '146.8', 'upperLimit': '184.6'}, {'value': '156.7', 'spread': '21.7', 'groupId': 'OG005', 'lowerLimit': '138.2', 'upperLimit': '175.3'}, {'value': '199.0', 'spread': '33.6', 'groupId': 'OG006', 'lowerLimit': '180.7', 'upperLimit': '217.3'}, {'value': '170.4', 'spread': '25.8', 'groupId': 'OG007', 'lowerLimit': '148.9', 'upperLimit': '191.9'}, {'value': '154.9', 'spread': '21.4', 'groupId': 'OG008', 'lowerLimit': '134.8', 'upperLimit': '175.0'}, {'value': '214.3', 'spread': '34.5', 'groupId': 'OG009', 'lowerLimit': '202.9', 'upperLimit': '225.7'}, {'value': '185.4', 'spread': '17.7', 'groupId': 'OG010', 'lowerLimit': '159.5', 'upperLimit': '211.3'}]}]}], 'analyses': [{'pValue': '0.368', 'groupIds': ['OG000', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-8.1', 'ciLowerLimit': '-23.0', 'ciUpperLimit': '6.8', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 15 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.079', 'groupIds': ['OG001', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-16.6', 'ciLowerLimit': '-32.2', 'ciUpperLimit': '-1.1', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 30 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.007', 'groupIds': ['OG002', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-25.7', 'ciLowerLimit': '-40.9', 'ciUpperLimit': '-10.5', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 45 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG003', 'OG009'], 'paramType': 'Diffrence in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-36.3', 'ciLowerLimit': '-52.0', 'ciUpperLimit': '-20.5', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.147', 'groupIds': ['OG004', 'OG010'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-19.7', 'ciLowerLimit': '-42.2', 'ciUpperLimit': '2.7', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 60 mg fed minus LS mean for placebo fed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.114', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '12.3', 'ciLowerLimit': '-0.5', 'ciUpperLimit': '25.2', 'estimateComment': 'Difference in least squares mean (LS mean) was calculated as LS mean for MK-1006 60 mg minus LS mean for MK-1006 60 mg fed.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.026', 'groupIds': ['OG009', 'OG010'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-28.9', 'ciLowerLimit': '-49.9', 'ciUpperLimit': '-7.9', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for placebo fed minus LS mean for placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG005', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-57.6', 'ciLowerLimit': '-73.3', 'ciUpperLimit': '-41.9', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 80 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '0.099', 'groupIds': ['OG006', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-15.3', 'ciLowerLimit': '-30.5', 'ciUpperLimit': '-0.1', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 100 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG007', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-43.9', 'ciLowerLimit': '-60.8', 'ciUpperLimit': '-27.0', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 140 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}, {'pValue': '<.001', 'groupIds': ['OG008', 'OG009'], 'paramType': 'Difference in least squares mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-59.4', 'ciLowerLimit': '-75.1', 'ciUpperLimit': '-43.7', 'pValueComment': 'A step down procedure starting with the highest tolerated dose was implemented.', 'estimateComment': 'The calculation used to determine the difference in least squares mean (LS mean) was LS mean for MK-1006 170 mg minus LS mean for placebo.', 'groupDescription': 'At one or more well tolerated single doses of MK-1006, the 24-hour weighted mean glucose concentration is expected to be at least 25 mg/dL lower than placebo.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Based on mixed effect model with glucose baseline, panel and treatment-within-panel as fixed effects and participant-within panel as a random effect.', 'testedNonInferiority': False}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Up to 36 hours', 'description': 'Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.', 'unitOfMeasure': 'mg/dL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants received a singe dose of MK-1006 following an overnight fast (for approximately 10 hours), except the MK-1006 60 mg fed arm in which participants received a single dose of MK-1006 following the consumption of a standard Japanese breakfast. The same participant may appear in more than one treatment arm.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A: MK-1006 15/30/45', 'description': 'Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.'}, {'id': 'FG001', 'title': 'Panel B: MK-1006 60/80/60 Fed', 'description': 'Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.'}, {'id': 'FG002', 'title': 'Panel C: MK-1006 100/140/170', 'description': 'Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.'}], 'periods': [{'title': 'Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Received MK-1006', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Received Matching Placebo to MK-1006', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '7 Day Wash-out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Abnormal Clinical Laboratory Test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}, {'title': 'Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Received MK-1006', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '4'}]}, {'type': 'Received Matching Placebo to MK-1006', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '7 Day Wash-out', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'Received MK-1006', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Received Matching Placebo to MK-1006', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A: MK-1006 15/30/45', 'description': 'Participants received a single dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.'}, {'id': 'BG001', 'title': 'Panel B: MK-1006 60/80/60 Fed', 'description': 'Participants received a single dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.'}, {'id': 'BG002', 'title': 'Panel C: MK-1006 100/140/170', 'description': 'Participants received a single dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<41 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': '>= 41 years and <=64 years', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}, {'title': '>64 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Japan', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-06', 'studyFirstSubmitDate': '2008-11-10', 'resultsFirstSubmitDate': '2012-09-07', 'studyFirstSubmitQcDate': '2008-11-13', 'lastUpdatePostDateStruct': {'date': '2016-01-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-09-07', 'studyFirstPostDateStruct': {'date': '2008-11-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Who Experienced at Least One Adverse Event', 'timeFrame': 'from the time of the run-in period prior to the first dose of study drug through the end of the poststudy period (up to approximately 31 days)', 'description': 'An adverse event 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 product.'}, {'measure': 'Number of Participants Who Discontinued Treatment Due to an Adverse Event', 'timeFrame': 'up to approximately 17 days', 'description': 'An adverse event 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 product.'}], 'secondaryOutcomes': [{'measure': 'Mean Area Under the Plasma Concentration Curve From Time Zero to Infinity(AUC[0-∞]) After a Single Dose of MK-1006', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'AUC(0-∞) was estimated by determining the total area under the curve of the concentration versus time curve extrapolated to infinity. The placebo group was not evaluated for this outcome measure.'}, {'measure': 'Mean Area Under the Plasma Concentration Curve From Time Zero to 24 Hours (AUC[0-24]) After a Single Dose of MK-1006', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'AUC(0 to 24 hours) was estimated by determining the total area under the curve of the concentration versus time curve to 24 hours post dose. The placebo group was not evaluated for this outcome measure.'}, {'measure': 'Mean Maximum Plasma Concentration (Cmax) After a Single Dose of MK-1006', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'The placebo group was not evaluated for this outcome measure.'}, {'measure': 'Median Time to Maximum Plasma Concentration (Tmax) After a Single Dose of MK-1006', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'The placebo group was not evaluated for this outcome measure.'}, {'measure': 'Apparent Terminal Half-life (T 1/2) After a Single Dose of MK-1006', 'timeFrame': 'Approximately 96 hours for MK-1006 15mg, 30 mg, 45 mg, 60 mg, 60 mg fed (predose up to approximately 96 hours postdose); approximately 120 hours for MK-1006 80 mg, 100 mg, 140 mg, and 170 mg (predose up to 120 hours postdose)', 'description': 'The apparent half-life was defined as the time required for the plasma concentration of MK-1006 to decrease 50% in the final stage of its elimination. The means and standard deviations displayed as are the harmonic means and pseudo-standard deviations, respectively. The placebo group was not evaluated for this outcome measure.'}, {'measure': '24-hour Weighted Mean Glucose (WMG) Concentration', 'timeFrame': 'Up to 36 hours', 'description': 'Weighted mean glucose concentration was calculated as the 24-hour area under the plasma concentration-time curve divided by 24.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, 'descriptionModule': {'briefSummary': 'A single rising dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-1006 in Japanese participants with Type 2 Diabetes Mellitus (T2DM). The primary hypothesis of the study is that single doses of MK-1006 will be sufficiently safe and well tolerated, based on the assessment of clinical and laboratory evaluations and adverse experiences, in Japanese participants with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Japanese male or female between 20 to 64 years of age\n* Diagnosis of type 2 diabetes\n* Patient is being treated with diet and exercise alone or single oral anti-hyperglycemic agent\n\nExclusion Criteria:\n\n* Subject has a history of type 1 diabetes mellitus\n* Subject has a clinical diagnosis of glaucoma\n* Subject has donated blood or participated in another clinical study in the past 12 weeks\n* Subject is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse in the past 6 months'}, 'identificationModule': {'nctId': 'NCT00791661', 'briefTitle': 'MK-1006 Single Dose Study in Japanese Type 2 Diabetes Patients (MK-1006-005)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single Dose Clinical Trial to Study the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of MK-1006 in Japanese Subject With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '1006-005'}, 'secondaryIdInfos': [{'id': '2008_584'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: MK-1006 15/30/45', 'description': 'Participants received a single rising dose of MK-1006 (dosed at 15 mg, 30 mg, and 45 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.', 'interventionNames': ['Drug: MK-1006', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: MK-1006 60/80/60 fed', 'description': 'Participants received a single rising dose of MK-1006 (dosed at 60 mg, 80 mg, and 60 mg fed state) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.', 'interventionNames': ['Drug: MK-1006', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: MK-1006 100/140/170', 'description': 'Participants received a single rising dose of MK-1006 (dosed at 100 mg, 140 mg, and 170 mg) or matching placebo to MK-1006 with a 7-day wash-out period between doses. Participants could have received both MK-1006 and matching placebo to MK-1006 over the 3 treatment periods.', 'interventionNames': ['Drug: MK-1006', 'Drug: Placebo']}], 'interventions': [{'name': 'MK-1006', 'type': 'DRUG', 'description': 'MK-1006 capsules in single oral doses beginning at 15 mg and rising to 45 mg in Panel A, beginning at 60 mg and rising to 80 mg and 60 mg fed state in Panel B, or beginning at 100 mg and rising to 170 mg in Panel C.', 'armGroupLabels': ['Panel A: MK-1006 15/30/45', 'Panel B: MK-1006 60/80/60 fed', 'Panel C: MK-1006 100/140/170']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Matching placebo to MK-1006 in a single oral dose', 'armGroupLabels': ['Panel A: MK-1006 15/30/45', 'Panel B: MK-1006 60/80/60 fed', 'Panel C: MK-1006 100/140/170']}]}, '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'}}}}