Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-27 @ 11:49 AM
Study NCT ID:
NCT01096160
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2010-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '11 days', 'eventGroups': [{'id': 'EG000', 'title': 'Panel A: MK-8266 BID, 1 mg', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Panel A: Placebo BID', 'description': 'Matching placebo capsules, administered orally BID for 10 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Panel B: MK-8266 BID, 1.8 mg', 'description': 'MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Panel B: Placebo BID', 'description': 'Matching placebo capsules, administered orally BID for 10 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Panel C: MK-8266 TID, 1.8 mg', 'description': 'MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 3, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Panel C: Placebo TID', 'description': 'Matching placebo capsules, administered orally TID for 10 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Panel D: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Panel D: Placebo TID', 'description': 'Matching placebo capsules, administered orally TID for 10 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 1, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG008', 'title': 'Panel E: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 5, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Panel E: Placebo TID', 'description': 'Matching placebo capsules, administered orally TID for 10 days', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 2, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 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{'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pollakiuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 2, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 2, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 13.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-8266 BID (1 mg)', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days'}, {'id': 'OG001', 'title': 'Panel A: Placebo', 'description': 'Matching placebo capsules, administered orally BID for 10 days'}, {'id': 'OG002', 'title': 'Panel B: MK-8266 BID (1.8 mg)', 'description': 'MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days'}, {'id': 'OG003', 'title': 'Panel B: Placebo', 'description': 'Matching placebo capsules, administered orally BID for 10 days'}, {'id': 'OG004', 'title': 'Panel C: MK-8266 TID (1.8 mg)', 'description': 'MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days'}, {'id': 'OG005', 'title': 'Panel C: Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}, {'id': 'OG006', 'title': 'Panel D: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days'}, {'id': 'OG007', 'title': 'Panel D: Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}, {'id': 'OG008', 'title': 'Panel E: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days'}, {'id': 'OG009', 'title': 'Panel E: Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}, {'value': '4', 'groupId': 'OG006'}, {'value': '1', 'groupId': 'OG007'}, {'value': '5', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 24 days', 'description': "Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. 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 sponsor's product, whether or not considered related to the use of the product.", 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug'}, {'type': 'PRIMARY', 'title': 'Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}, {'value': '2', 'groupId': 'OG007'}, {'value': '6', 'groupId': 'OG008'}, {'value': '2', 'groupId': 'OG009'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-8266 BID (1 mg)', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days'}, {'id': 'OG001', 'title': 'Panel A: Placebo', 'description': 'Matching placebo capsules, administered orally BID for 10 days'}, {'id': 'OG002', 'title': 'Panel B: MK-8266 BID (1.8 mg)', 'description': 'MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days'}, {'id': 'OG003', 'title': 'Panel B: Placebo', 'description': 'Matching placebo capsules, administered orally BID for 10 days'}, {'id': 'OG004', 'title': 'Panel C: MK-8266 TID, 1.8 mg', 'description': 'MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days'}, {'id': 'OG005', 'title': 'Panel C: Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}, {'id': 'OG006', 'title': 'Panel D: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days'}, {'id': 'OG007', 'title': 'Panel D: Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}, {'id': 'OG008', 'title': 'Panel E: MK-8266 2.4 mg TID', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days'}, {'id': 'OG009', 'title': 'Panel E: Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}, {'value': '0', 'groupId': 'OG008'}, {'value': '1', 'groupId': 'OG009'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 10 days', 'description': "Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. 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 SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10.", 'unitOfMeasure': 'Count of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-8266 BID, 1 mg', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days'}, {'id': 'OG001', 'title': 'Panel B: MK-8266 BID, 1.8 mg', 'description': 'MK-8266 1.8 mg (1 mg AM+ 0.8 mg PM), administered orally for 10 days'}, {'id': 'OG002', 'title': 'Panel C: MK-8266 TID, 1.8 mg', 'description': 'MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days'}, {'id': 'OG003', 'title': 'Panels D & E Combined: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.'}, {'id': 'OG004', 'title': 'Pooled Placebo', 'description': 'Matching placebo capsules from Panels A, B, C, D \\& E, administered orally BID or TID for 10 days'}], 'classes': [{'title': 'Baseline value', 'categories': [{'measurements': [{'value': '141.5', 'spread': '8.96', 'groupId': 'OG000'}, {'value': '132.6', 'spread': '6.66', 'groupId': 'OG001'}, {'value': '148.6', 'spread': '23.77', 'groupId': 'OG002'}, {'value': '134.5', 'spread': '8.98', 'groupId': 'OG003'}, {'value': '146.7', 'spread': '12.07', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline at Day 10', 'categories': [{'measurements': [{'value': '-5.09', 'spread': '7.04', 'groupId': 'OG000'}, {'value': '-2.18', 'spread': '6.80', 'groupId': 'OG001'}, {'value': '-4.78', 'spread': '7.64', 'groupId': 'OG002'}, {'value': '0.77', 'spread': '6.62', 'groupId': 'OG003'}, {'value': '-3.18', 'spread': '7.72', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1194', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-7.08', 'ciLowerLimit': '-17.1', 'ciUpperLimit': '2.92', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in SBP (TWA\\^0-24hrs)'}, {'pValue': '0.0224', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-13.1', 'ciLowerLimit': '-23.7', 'ciUpperLimit': '-2.48', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in SBP (TWA\\^0-24hrs)'}, {'pValue': '0.4791', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.33', 'ciLowerLimit': '-10.3', 'ciUpperLimit': '10.91', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in SBP (TWA\\^0-24hrs)'}, {'pValue': '0.0705', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-8.21', 'ciLowerLimit': '-17.4', 'ciUpperLimit': '1.01', 'groupDescription': 'Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.', 'statisticalMethod': 'Linear mixed effcts model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in SBP (TWA\\^0-24hrs)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 10', 'description': 'Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\\^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.', 'unitOfMeasure': 'Millimeters of mercury (mmHg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had SBP assessments at Baseline and on Day 10'}, {'type': 'PRIMARY', 'title': 'Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-8266 BID (1 mg)', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days'}, {'id': 'OG001', 'title': 'Panel B: MK-8266 BID (1.8 mg)', 'description': 'MK-8266 1.8 mg (1 mg AM + 0.8 mg PM), administered orally for 10 days'}, {'id': 'OG002', 'title': 'Panel C: MK-8266 TID (1.8 mg)', 'description': 'MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days'}, {'id': 'OG003', 'title': 'Panels D & E Combined: MK-8266 TID: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.'}, {'id': 'OG004', 'title': 'Pooled Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '65.89', 'spread': '5.59', 'groupId': 'OG000'}, {'value': '69.32', 'spread': '7.87', 'groupId': 'OG001'}, {'value': '62.30', 'spread': '5.28', 'groupId': 'OG002'}, {'value': '66.10', 'spread': '5.38', 'groupId': 'OG003'}, {'value': '62.04', 'spread': '5.98', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.1161', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '3.85', 'ciLowerLimit': '-1.51', 'ciUpperLimit': '9.22', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}, {'pValue': '0.0189', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '7.28', 'ciLowerLimit': '1.60', 'ciUpperLimit': '12.97', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}, {'pValue': '0.4689', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.26', 'ciLowerLimit': '-5.42', 'ciUpperLimit': '5.95', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}, {'pValue': '0.0869', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '4.06', 'ciLowerLimit': '-0.89', 'ciUpperLimit': '9.01', 'groupDescription': 'Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}], 'paramType': 'MEAN', 'timeFrame': 'Day 10 (24 hours postdose)', 'description': 'Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\\^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had HR assessments 24 hours postdose on Day 10.'}, {'type': 'SECONDARY', 'title': 'Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-8266 BID, 1 mg', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days'}, {'id': 'OG001', 'title': 'Panel B: MK-8266 BID, 1.8 mg', 'description': 'MK-8266 1.8 mg (1 mg AM+ 0.8 mg PM), administered orally for 10 days'}, {'id': 'OG002', 'title': 'Panel C: MK-8266 TID, 1.8 mg', 'description': 'MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days'}, {'id': 'OG003', 'title': 'Panels D & E Combined: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.'}, {'id': 'OG004', 'title': 'Pooled Placebo', 'description': 'Matching placebo capsules from Panels A, B, C, D \\& E, administered orally BID or TID for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '8.81', 'spread': '4.86', 'groupId': 'OG000'}, {'value': '7.45', 'spread': '2.59', 'groupId': 'OG001'}, {'value': '13.50', 'spread': '8.95', 'groupId': 'OG002'}, {'value': '11.89', 'spread': '7.00', 'groupId': 'OG003'}, {'value': '18.68', 'spread': '6.68', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-9.87', 'ciLowerLimit': '-15.7', 'ciUpperLimit': '-4.09', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}, {'pValue': '0.002', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-11.2', 'ciLowerLimit': '-17.3', 'ciUpperLimit': '-5.10', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}, {'pValue': '0.080', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-5.18', 'ciLowerLimit': '-11.3', 'ciUpperLimit': '0.95', 'statisticalMethod': 'Linear mixed effcts model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Comparison of Day 10 values (TWA\\^0-24hrs) for MK-8266 vs placebo'}, {'pValue': '0.019', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-6.79', 'ciLowerLimit': '-12.1', 'ciUpperLimit': '-1.46', 'groupDescription': 'Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.', 'statisticalMethod': 'Linear mixed effcts model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in AIx (TWA\\^0-24hrs)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 10', 'description': 'Assessment of the central, ascending aortic blood pressure augmentation index (AIx), based on measurement of central pulse pressure at selected time points on Day 10, as measured by applanation tonometry of the radial artery. This outcome measure assessed the time weighted average change over 24 hours postdose (TWA\\^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had AIx assessment on Day 10'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Panel A: MK-8266 BID, 1 mg', 'description': 'MK-8266 1 mg (0.7 mg AM + 0.3 mg PM), administered orally for 10 days'}, {'id': 'OG001', 'title': 'Panel B: MK-8266 BID, 1.8 mg', 'description': 'MK-8266 1.8 mg (1 mg AM+ 0.8 mg PM), administered orally for 10 days'}, {'id': 'OG002', 'title': 'Panel C: MK-8266 TID, 1.8 mg', 'description': 'MK-8266 0.6 mg TID as oral capsules (1.8 mg) for 10 days'}, {'id': 'OG003', 'title': 'Panels D & E Combined: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.'}, {'id': 'OG004', 'title': 'Pooled Placebo', 'description': 'Matching placebo capsules from Panels A, B, C, D \\& E, administered orally BID or TID for 10 days'}], 'classes': [{'title': 'Baseline value', 'categories': [{'measurements': [{'value': '1.61', 'spread': '0.77', 'groupId': 'OG000'}, {'value': '0.74', 'spread': '0.50', 'groupId': 'OG001'}, {'value': '1.69', 'spread': '1.15', 'groupId': 'OG002'}, {'value': '2.68', 'spread': '1.29', 'groupId': 'OG003'}, {'value': '0.54', 'spread': '0.21', 'groupId': 'OG004'}]}]}, {'title': 'Change from Baseline at Day 10', 'categories': [{'measurements': [{'value': '1.34', 'spread': '2.74', 'groupId': 'OG000'}, {'value': '1.74', 'spread': '4.62', 'groupId': 'OG001'}, {'value': '0.43', 'spread': '0.66', 'groupId': 'OG002'}, {'value': '0.81', 'spread': '2.78', 'groupId': 'OG003'}, {'value': '1.05', 'spread': '1.16', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.318', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.28', 'ciLowerLimit': '0.53', 'ciUpperLimit': '3.05', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in cGMP'}, {'pValue': '0.17', 'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.66', 'ciLowerLimit': '0.66', 'ciUpperLimit': '4.17', 'statisticalMethod': 'Linear mixed effects model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in cGMP'}, {'pValue': '0.054', 'groupIds': ['OG002', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.41', 'ciLowerLimit': '0.16', 'ciUpperLimit': '1.02', 'statisticalMethod': 'Linear mixed effcts model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in cGMP'}, {'pValue': '0.297', 'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.78', 'ciLowerLimit': '0.35', 'ciUpperLimit': '1.73', 'groupDescription': 'Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Panel D was completed prior to initiation of Panel E.', 'statisticalMethod': 'Linear mixed effcts model', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Difference in change from baseline in cGMP'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline and Day 10', 'description': 'Assessment of whole blood samples for cGMP analysis, based on samples obtained predose as well as 4 and 24 hours postdose on Day 1 and Day 10, and predose only on Day 4. The change from baseline in cGMP was assessed at 24 hours postdose on Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.', 'unitOfMeasure': 'nanomoles (nM)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had cGMP assessments at Baseline and on Day 10'}, {'type': 'SECONDARY', 'title': 'Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panels D & E Combined: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.3', 'spread': '29.81', 'groupId': 'OG000'}, {'value': '-12.4', 'spread': '18.89', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 10 (5 hours postdose)', 'description': "The percent inhibition of ADP-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of ADP (2.5 µM) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10 only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo.", 'unitOfMeasure': 'Percent inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment of ADP-induced platelet aggregation on Day 10'}, {'type': 'SECONDARY', 'title': 'Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Panels D & E Combined: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days. Panel D was completed prior to initiation of Panel E.'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.7', 'spread': '26.30', 'groupId': 'OG000'}, {'value': '-8.87', 'spread': '33.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 10 (5 hours postdose)', 'description': "The percent inhibition of collagen-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of collagen (2 µg/mL) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10, only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo.", 'unitOfMeasure': 'Percent inhibition', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received at least one dose of the investigational drug and had assessment of collagen-induced platelet aggregation on Day 10'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Panel A: MK-8266 BID (1 mg)', 'description': 'MK-8266 BID 1 mg, administered as oral capsules (0.7 mg AM + 0.3 mg PM) for 10 days'}, {'id': 'FG001', 'title': 'Panel A: Placebo BID', 'description': 'Matching placebo capsules, administered orally for 10 days'}, {'id': 'FG002', 'title': 'Panel B: MK-8266 BID (1.8 mg)', 'description': 'MK-8266 BID 1.8 mg, administered as oral capsules (1 mg AM + 0.8 mg PM) for 10 days'}, {'id': 'FG003', 'title': 'Panel B: Placebo BID', 'description': 'Matching placebo capsules, administered orally BID for 10 days'}, {'id': 'FG004', 'title': 'Panel C: MK-8266 TID (1.8 mg)', 'description': 'MK-8266 0.6 mg TID, administered as oral capsules (1.8 mg) for 10 days'}, {'id': 'FG005', 'title': 'Panel C: Placebo TID', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}, {'id': 'FG006', 'title': 'Panel D: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days'}, {'id': 'FG007', 'title': 'Panel D: Placebo TID', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}, {'id': 'FG008', 'title': 'Panel E: MK-8266 TID (2.4 mg)', 'description': 'MK-8266 0.8 mg TID, administered as oral capsules (2.4 mg) for 10 days'}, {'id': 'FG009', 'title': 'Panel E: Placebo TID', 'description': 'Matching placebo capsules, administered orally TID for 10 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '6'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '6'}, {'groupId': 'FG009', 'numSubjects': '2'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '4'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Met stopping criteria per protocol', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '40', 'groupId': 'BG010'}]}], 'groups': [{'id': 'BG000', 'title': 'Panel A: MK-8266 BID, 1 mg', 'description': 'MK-8266 BID 1 mg, administered as oral capsules (0.7 mg AM + 0.3 mg PM) for 10 days, or as matching placebo'}, {'id': 'BG001', 'title': 'Panel A: Placebo BID', 'description': 'Matching placebo capsules, administered orally for 10 days'}, {'id': 'BG002', 'title': 'Panel B: MK-8266 BID, 1.8 mg', 'description': 'MK-8266 BID 1 mg, administered as oral capsules (1 mg AM + 0.8 mg PM) for 10 days'}, {'id': 'BG003', 'title': 'Panel B: Placebo BID', 'description': 'Matching placebo capsules, administered orally for 10 days'}, {'id': 'BG004', 'title': 'Panel C: MK-8266 TID, 1.8 mg', 'description': 'MK-8266 TID 1.8 mg, administered as oral capsules (0.6 mg q6hr) for 10 days'}, {'id': 'BG005', 'title': 'Panel C: Placebo TID', 'description': 'Matching placebo capsules, administered orally for 10 days'}, {'id': 'BG006', 'title': 'Panel D: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 TID 2.4 mg, administered as oral capsules (0.8 mg q6hr) for 10 days'}, {'id': 'BG007', 'title': 'Panel D: Placebo TID', 'description': 'Matching placebo capsules, administered orally for 10 days'}, {'id': 'BG008', 'title': 'Panel E: MK-8266 TID, 2.4 mg', 'description': 'MK-8266 TID 2.4 mg, administered as oral capsules (0.8 mg q6hr) for 10 days'}, {'id': 'BG009', 'title': 'Panel E: Placebo TID', 'description': 'Matching placebo capsules, administered orally for 10 days'}, {'id': 'BG010', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '47.5', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '52.0', 'spread': '1.4', 'groupId': 'BG003'}, {'value': '46.5', 'spread': '3.4', 'groupId': 'BG004'}, {'value': '54.0', 'spread': '1.4', 'groupId': 'BG005'}, {'value': '46.2', 'spread': '5.5', 'groupId': 'BG006'}, {'value': '46.5', 'spread': '7.8', 'groupId': 'BG007'}, {'value': '47.2', 'spread': '5.2', 'groupId': 'BG008'}, {'value': '48.5', 'spread': '0.7', 'groupId': 'BG009'}, {'value': '47.6', 'spread': '4.9', 'groupId': 'BG010'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '0', 'groupId': 'BG008'}, {'value': '0', 'groupId': 'BG009'}, {'value': '0', 'groupId': 'BG010'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '6', 'groupId': 'BG006'}, {'value': '2', 'groupId': 'BG007'}, {'value': '6', 'groupId': 'BG008'}, {'value': '2', 'groupId': 'BG009'}, {'value': '40', 'groupId': 'BG010'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Baseline HR', 'classes': [{'categories': [{'measurements': [{'value': '70', 'groupId': 'BG000', 'lowerLimit': '53', 'upperLimit': '91'}, {'value': '90', 'groupId': 'BG001', 'lowerLimit': '71', 'upperLimit': '108'}, {'value': '79', 'groupId': 'BG002', 'lowerLimit': '71', 'upperLimit': '92'}, {'value': '89', 'groupId': 'BG003', 'lowerLimit': '79', 'upperLimit': '99'}, {'value': '74', 'groupId': 'BG004', 'lowerLimit': '43', 'upperLimit': '85'}, {'value': '69', 'groupId': 'BG005', 'lowerLimit': '65', 'upperLimit': '72'}, {'value': '72', 'groupId': 'BG006', 'lowerLimit': '59', 'upperLimit': '84'}, {'value': '88', 'groupId': 'BG007', 'lowerLimit': '79', 'upperLimit': '96'}, {'value': '74', 'groupId': 'BG008', 'lowerLimit': '60', 'upperLimit': '127'}, {'value': '81', 'groupId': 'BG009', 'lowerLimit': '67', 'upperLimit': '94'}, {'value': '73', 'groupId': 'BG010', 'lowerLimit': '43', 'upperLimit': '127'}]}]}], 'paramType': 'MEDIAN', 'description': 'Measurements of HR were obtained in triplicate using a validated, semi-automated oscillometric device, and the triplicate measurements were recorded as median values', 'unitOfMeasure': 'Beats per minute', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'All participants who received at least one dose of the investigational drug'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-06', 'completionDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-06-24', 'studyFirstSubmitDate': '2010-03-26', 'resultsFirstSubmitDate': '2018-02-21', 'studyFirstSubmitQcDate': '2010-03-29', 'lastUpdatePostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-24', 'studyFirstPostDateStruct': {'date': '2010-03-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Participants Receiving MK-8266 or Placebo Who Experienced At Least One Adverse Event (AE) During Treatment and Postdose Follow-up', 'timeFrame': 'Up to 24 days', 'description': "Assessment of the number of participants with at least one clinical or laboratory AE in those receiving multiple oral doses of MK-8266. 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 sponsor's product, whether or not considered related to the use of the product."}, {'measure': 'Participants Receiving MK-8266 or Placebo Who Discontinued Treatment Due to an AE', 'timeFrame': 'Up to 10 days', 'description': "Assessment of the number of participants receiving MK-8266 who discontinued therapy due to an AE over 10 days of treatment. 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 SPONSOR's product, whether or not considered related to the use of the product. The number of participants in any treatment group who discontinued therapy due to an AE was primarily assessed for Days 0-10."}, {'measure': 'Change From Baseline in Systolic Blood Pressure (SBP) Following Multiple Oral Doses of MK-8266 or Placebo', 'timeFrame': 'Baseline and Day 10', 'description': 'Assessment of the change from baseline in SBP, obtained using a validated, semi-automated oscillometric device. Evaluated for MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\\^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis.'}, {'measure': 'Heart Rate (HR) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo', 'timeFrame': 'Day 10 (24 hours postdose)', 'description': 'Assessment of HR (beats/min) on Day 10 (24-hours postdose) with MK-8266 relative to placebo in participants, as measured by the time weighted average change over 24 hours postdose (TWA\\^0-24hrs). Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this analysis. Baseline HR values are shown in the Baseline Characteristics section for Panels A, B, C, D, E.'}], 'secondaryOutcomes': [{'measure': 'Aortic Augmentation Index (AIx) on Day 10 Following Multiple Oral Doses of MK-8266 or Placebo', 'timeFrame': 'Day 10', 'description': 'Assessment of the central, ascending aortic blood pressure augmentation index (AIx), based on measurement of central pulse pressure at selected time points on Day 10, as measured by applanation tonometry of the radial artery. This outcome measure assessed the time weighted average change over 24 hours postdose (TWA\\^0-24hrs) on dosing Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.'}, {'measure': 'Change From Baseline in Cyclic Guanosine Monophosphate (cGMP) Following Multiple Oral Doses of MK-8266 or Placebo', 'timeFrame': 'Baseline and Day 10', 'description': 'Assessment of whole blood samples for cGMP analysis, based on samples obtained predose as well as 4 and 24 hours postdose on Day 1 and Day 10, and predose only on Day 4. The change from baseline in cGMP was assessed at 24 hours postdose on Day 10. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this assessment.'}, {'measure': 'Percent Inhibition of Platelet Aggregation Induced by Adenosine Diphosphate (ADP) Following Multiple Oral Doses of MK-8266 or Placebo', 'timeFrame': 'Baseline and Day 10 (5 hours postdose)', 'description': "The percent inhibition of ADP-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of ADP (2.5 µM) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10 only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo."}, {'measure': 'Percent Inhibition of Platelet Aggregation Induced by Collagen Following Multiple Oral Doses of MK-8266 or Placebo', 'timeFrame': 'Baseline and Day 10 (5 hours postdose)', 'description': "The percent inhibition of collagen-induced platelet aggregation from Baseline to 5 hours postdose on Day 10 was assessed and is summarized here. Platelet aggregation was initiated by addition of collagen (2 µg/mL) to the participant's blood sample. Aggregation was followed for 5 minutes after addition of the agonist, and the maximum percent of light transmission (extent of aggregation) obtained during this period, as well as the instrument-calculated slope (rate of aggregation), were reported. Post treatment platelet aggregation is expressed as a percent of each participant's pretreatment level of aggregation. Panel D and Panel E had identical treatments (MK-8266 0.8 mg TID), which were combined for this summary. The data are very limited. On Day 10, only 8 participants received MK-8266 0.8 mg TID and 3 participants received placebo."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Hypertension'], 'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'This study evaluated adverse events (AEs), study discontinuation due to AEs, and pharmacodynamics of MK-8266 in male participants with mild to moderate hypertension.', 'detailedDescription': 'This study evaluated AEs, discontinuation due to AEs, and effects on hemodynamic parameters, including systolic blood pressure (SBP) and aortic augmentation index (AIx), following multiple oral doses of MK-8266. Five serial panels, each consisting of eight participants (40 participants in Panels A, B, C, D, and E), were randomized to receive either MK-8266 or matching placebo twice daily (BID) or three times daily (TID) for 10 consecutive days. Although the original plan was to evaluate MK-8266 treatment in Panels D and E using both BID and TID regimens, the study actually evaluated identical TID regimens in these panels.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is male with essential hypertension (high blood pressure)\n* Participant is in good general health (with the exception of hypertension)\n* Participant has a Body Mass Index (BMI) \\<= 33 kg/m\\^2 at the Screening visit\n* Participant has a platelet count \\>= 150,000 cu/mL at the Screening visit\n* Participant has a positive AIx at the Screening visit\n\nExclusion Criteria:\n\n* Participant has a history of stroke, chronic seizure, or major neurological disease\n* Participant has a functional disability that can interfere with rising from a seated position to the standing position\n* Participant has any history of a bleeding or clotting disorder\n* Participant has a history of cancer\n* Participant is unable to refrain from or anticipates the use of any prescription or non-prescription medication\n* Participant consumes excessive amounts of alcohol or caffeinated beverages daily'}, 'identificationModule': {'nctId': 'NCT01096160', 'briefTitle': 'A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK8266 in Hypertensive Men (MK-8266-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of MK-8266', 'orgStudyIdInfo': {'id': '8266-002'}, 'secondaryIdInfos': [{'id': '2010-018654-13', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Panel A: MK-8266 BID, 1 mg/Placebo', 'description': 'MK-8266 1 mg (0.7 mg in the morning \\[AM\\] + 0.3 mg in the evening \\[PM\\]), or as matching placebo BID.', 'interventionNames': ['Drug: MK-8226 BID, 1 mg', 'Drug: Placebo BID (Panel A)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel B: MK-8266 BID, 1.8 mg/Placebo', 'description': 'MK-8266 1.8 mg (1 mg in the AM + 0.8 mg in the PM), or as matching placebo BID.', 'interventionNames': ['Drug: MK-8266 BID, 1.8 mg', 'Drug: Placebo BID (Panel B)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel C: MK-8266 TID, 1.8 mg/Placebo', 'description': 'MK-8266 TID, 1.8 mg (0.6 mg every 6 hours \\[q6hr\\]), or as matching placebo TID.', 'interventionNames': ['Drug: MK-8266 TID, 1.8 mg', 'Drug: Placebo TID (Panel C)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel D: MK-8266 TID, 2.4 mg/Placebo', 'description': 'MK-8266 TID (Panel D), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel D was completed prior to initiation of Panel E.', 'interventionNames': ['Drug: MK-8266 TID, 2.4 mg', 'Drug: Placebo TID (Panel D)']}, {'type': 'EXPERIMENTAL', 'label': 'Panel E: MK-8266 TID, 2.4 mg/Placebo', 'description': 'MK-8266 TID (Panel E), 2.4 mg (0.8 mg q6hr), or as matching placebo TID. Panel E was initiated after completion of Panel D.', 'interventionNames': ['Drug: MK-8266 TID, 2.4 mg', 'Drug: Placebo TID (Panel E)']}], 'interventions': [{'name': 'MK-8226 BID, 1 mg', 'type': 'DRUG', 'otherNames': ['MK-8266'], 'description': 'MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.', 'armGroupLabels': ['Panel A: MK-8266 BID, 1 mg/Placebo']}, {'name': 'MK-8266 BID, 1.8 mg', 'type': 'DRUG', 'otherNames': ['MK-8266'], 'description': 'MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.', 'armGroupLabels': ['Panel B: MK-8266 BID, 1.8 mg/Placebo']}, {'name': 'MK-8266 TID, 1.8 mg', 'type': 'DRUG', 'otherNames': ['MK-8266'], 'description': 'MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.', 'armGroupLabels': ['Panel C: MK-8266 TID, 1.8 mg/Placebo']}, {'name': 'MK-8266 TID, 2.4 mg', 'type': 'DRUG', 'otherNames': ['MK-8266'], 'description': 'MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.', 'armGroupLabels': ['Panel D: MK-8266 TID, 2.4 mg/Placebo']}, {'name': 'MK-8266 TID, 2.4 mg', 'type': 'DRUG', 'otherNames': ['MK-8266'], 'description': 'MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.', 'armGroupLabels': ['Panel E: MK-8266 TID, 2.4 mg/Placebo']}, {'name': 'Placebo BID (Panel A)', 'type': 'DRUG', 'description': 'Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.', 'armGroupLabels': ['Panel A: MK-8266 BID, 1 mg/Placebo']}, {'name': 'Placebo BID (Panel B)', 'type': 'DRUG', 'description': 'Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.', 'armGroupLabels': ['Panel B: MK-8266 BID, 1.8 mg/Placebo']}, {'name': 'Placebo TID (Panel C)', 'type': 'DRUG', 'description': 'Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.', 'armGroupLabels': ['Panel C: MK-8266 TID, 1.8 mg/Placebo']}, {'name': 'Placebo TID (Panel D)', 'type': 'DRUG', 'description': 'Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.', 'armGroupLabels': ['Panel D: MK-8266 TID, 2.4 mg/Placebo']}, {'name': 'Placebo TID (Panel E)', 'type': 'DRUG', 'description': 'Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.', 'armGroupLabels': ['Panel E: MK-8266 TID, 2.4 mg/Placebo']}]}, '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': 'http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}