Ignite Creation Date:
2025-12-24 @ 7:37 PM
Ignite Modification Date:
2025-12-30 @ 8:39 PM
Study NCT ID:
NCT04568603
Status:
COMPLETED
Last Update Posted:
2025-01-28
First Post:
2020-09-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Islatravir and Methadone Pharmacokinetics (MK-8591-029)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C558823', 'term': 'islatravir'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@msd.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 16 days (up to 14 days after methadone + ISL coadministration on Day 2)', 'description': 'All enrolled study participants are included in analysis of all-cause mortality. All participants who received ISL on Day 2 are included in analysis of serious AEs (SAEs) and nonserious AEs.', 'eventGroups': [{'id': 'EG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 4, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Infusion site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Increased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Papule', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] QD from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '61.9', 'groupId': 'OG000', 'lowerLimit': '49.3', 'upperLimit': '77.7'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '63.9', 'groupId': 'OG000', 'lowerLimit': '52.2', 'upperLimit': '78.1'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '1.00', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the 90% CI for the geometric mean ratio (GMR) of methadone+ ISL to methadone alone is contained within the interval (0.70, 1.43).'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The AUC0-24 of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng*h/mL/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'PRIMARY', 'title': 'Dose-Normalized AUC0-24 of S-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '63.1', 'groupId': 'OG000', 'lowerLimit': '48.9', 'upperLimit': '81.5'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '65.1', 'groupId': 'OG000', 'lowerLimit': '51.7', 'upperLimit': '82.0'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The AUC0-24hr of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng*h/mL/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '3.64', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '4.43'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '3.71', 'groupId': 'OG000', 'lowerLimit': '3.14', 'upperLimit': '4.40'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.02', 'ciLowerLimit': '0.96', 'ciUpperLimit': '1.09', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to the methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 1.43.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Cmax of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng/mL/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '2.09', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '2.69'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '2.23', 'groupId': 'OG000', 'lowerLimit': '1.78', 'upperLimit': '2.78'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.06', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.10', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: 24 hours postdose', 'description': 'The C24 of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng/ml/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Time to Maximum Plasma Concentration (Tmax) of R-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.47', 'upperLimit': '3.00'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '4.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Tmax of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized Cmax of S-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '4.25', 'groupId': 'OG000', 'lowerLimit': '3.45', 'upperLimit': '5.25'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '4.31', 'groupId': 'OG000', 'lowerLimit': '3.49', 'upperLimit': '5.32'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.01', 'ciLowerLimit': '0.94', 'ciUpperLimit': '1.09', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Cmax of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng/mL/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized C24 of S-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '1.91', 'groupId': 'OG000', 'lowerLimit': '1.44', 'upperLimit': '2.54'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '2.07', 'groupId': 'OG000', 'lowerLimit': '1.60', 'upperLimit': '2.68'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.08', 'ciLowerLimit': '1.04', 'ciUpperLimit': '1.13', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: 24 hours postdose', 'description': 'The C24 of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng/ml/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Tmax of S-Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '1.02', 'upperLimit': '3.00'}]}]}, {'title': 'Day 2:Methadone + ISL', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Tmax of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized AUC0-24 of Total Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '126', 'groupId': 'OG000', 'lowerLimit': '99.1', 'upperLimit': '159'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000', 'lowerLimit': '105', 'upperLimit': '160'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.03', 'ciLowerLimit': '0.99', 'ciUpperLimit': '1.07', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The AUC0-24hr of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng*h/mL/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized Cmax of Total Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '7.91', 'groupId': 'OG000', 'lowerLimit': '6.48', 'upperLimit': '9.66'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '8.02', 'groupId': 'OG000', 'lowerLimit': '6.64', 'upperLimit': '9.68'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.01', 'ciLowerLimit': '0.95', 'ciUpperLimit': '1.08', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Cmax of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng/mL/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Dose-Normalized C24 of Total Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '4.03', 'groupId': 'OG000', 'lowerLimit': '3.10', 'upperLimit': '5.23'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '4.32', 'groupId': 'OG000', 'lowerLimit': '3.42', 'upperLimit': '5.45'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'GMR', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.07', 'ciLowerLimit': '1.03', 'ciUpperLimit': '1.11', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The hypothesis that administration of methadone + ISL is similar to methadone alone will be supported if the upper bound of the 90% CI for the GMR of methadone+ ISL to methadone alone is below 2.0.'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Days 1 and 2: 24 hours postdose', 'description': 'The C24 of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.', 'unitOfMeasure': 'ng/ml/mg', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Tmax of Total Methadone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'title': 'Day 1: Methadone Alone', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '1.47', 'upperLimit': '3.00'}]}]}, {'title': 'Day 2: Methadone + ISL', 'categories': [{'measurements': [{'value': '2.00', 'groupId': 'OG000', 'lowerLimit': '0.67', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Tmax of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL).', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who complied with the protocol sufficiently to ensure that generated data were likely to exhibit the effects of treatment, according to the underlying scientific model, are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs) Following Methadone + ISL Coadministration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 16 days', 'description': 'The number of participants with AEs will be determined for 14 days after coadministration of methadone and ISL on Day 2.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ISL on Day 2 are included.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Discontinuing Study Therapy Due to AEs Following Coadministration of Methadone and ISL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 15 days', 'description': 'The number of participants discontinuing study therapy due to AEs after methadone + ISL on Day 2 will be determined.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who received ISL on Day 2 are included.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with islatravir (ISL) 60 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Received ISL on Day 2', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Methadone-maintained participants were recruited at 2 study sites in the United States.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] QD from Day -14 to Day -1) receive their usual methadone dose on Day 1 and Days 3 to 14. On Day 2, methadone is coadministered with ISL 60 mg.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '12.0', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-28', 'size': 803643, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-01T10:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-15', 'studyFirstSubmitDate': '2020-09-23', 'resultsFirstSubmitDate': '2022-06-01', 'studyFirstSubmitQcDate': '2020-09-23', 'lastUpdatePostDateStruct': {'date': '2025-01-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-28', 'studyFirstPostDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dose-Normalized Area Under the Plasma Concentration Time Curve From 0-24 Hours Postdose (AUC0-24) of R-Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The AUC0-24 of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Dose-Normalized AUC0-24 of S-Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The AUC0-24hr of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}], 'secondaryOutcomes': [{'measure': 'Dose-Normalized Maximum Plasma Concentration (Cmax) of R-Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Cmax of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Dose-Normalized Plasma Concentration 24 Hours Postdose (C24) of R-Methadone', 'timeFrame': 'Days 1 and 2: 24 hours postdose', 'description': 'The C24 of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Time to Maximum Plasma Concentration (Tmax) of R-Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Tmax of R-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL).'}, {'measure': 'Dose-Normalized Cmax of S-Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Cmax of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Dose-Normalized C24 of S-Methadone', 'timeFrame': 'Days 1 and 2: 24 hours postdose', 'description': 'The C24 of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Tmax of S-Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Tmax of S-methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL).'}, {'measure': 'Dose-Normalized AUC0-24 of Total Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The AUC0-24hr of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Dose-Normalized Cmax of Total Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Cmax of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Dose-Normalized C24 of Total Methadone', 'timeFrame': 'Days 1 and 2: 24 hours postdose', 'description': 'The C24 of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL). Back-transformed least-squares mean and confidence interval from mixed effects model were performed on natural log-transformed values; data show the geometric least squares mean.'}, {'measure': 'Tmax of Total Methadone', 'timeFrame': 'Days 1 and 2: predose and 0.5, 1, 1.5, 2, 3, 4, 6, 12, 16, and 24 hours postdose', 'description': 'The Tmax of total methadone was determined on Day 1 (methadone) and Day 2 (methadone + ISL).'}, {'measure': 'Number of Participants With Adverse Events (AEs) Following Methadone + ISL Coadministration', 'timeFrame': 'Up to 16 days', 'description': 'The number of participants with AEs will be determined for 14 days after coadministration of methadone and ISL on Day 2.'}, {'measure': 'Number of Participants Discontinuing Study Therapy Due to AEs Following Coadministration of Methadone and ISL', 'timeFrame': 'Up to 15 days', 'description': 'The number of participants discontinuing study therapy due to AEs after methadone + ISL on Day 2 will be determined.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['HIV-1 Infection']}, 'referencesModule': {'references': [{'pmid': '39648614', 'type': 'RESULT', 'citation': 'Matthews RP, Ankrom W, Handy W, Patel M, Matthews C, Xu Z, Gravesande K, Searle S, Schwartz H, Stoch SA, Iwamoto M. A Phase 1 Study to Evaluate the Pharmacokinetic Drug-Drug Interaction Between Islatravir and Methadone in Participants on Stable Methadone Therapy. Clin Pharmacol Drug Dev. 2025 Jan;14(1):36-43. doi: 10.1002/cpdd.1492. Epub 2024 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'The present study is designed to determine the effect of islatravir (ISL) \\[MK-8591\\] on methadone pharmacokinetics (PK). The primary objective is to assess whether ISL impacts the area under the plasma concentration time curve from dosing to 24 hours postdose (AUC0-24) of S-methadone and R-methadone in participants on oral methadone therapy. It is hypothesized that the plasma AUC0-24hr for S- and R-methadone will be similar after methadone alone compared to methadone and ISL 60 mg coadministration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has a body mass index (BMI) \\> 18 and ≤ 35 kg/m\\^2\n* Is in good health based on laboratory safety tests obtained at the screening visit and prior to administration of study drug\n* Is in good health based on medical history, physical examination, vital sign measurements, and electrocardiograms (ECGs) performed prior to randomization.\n* Has a negative human immunodeficiency virus (HIV) antigen/antibody test at screening\n* For male participants, follows contraception guidance consistent with local regulations\n* For female participants:\n* Is not a woman of childbearing potential (WOCBP) or\n* Is a WOCBP and using acceptable contraception or is abstinent\n* Is reliably participating in a methadone maintenance program for at least two (2) months prior to Day 1\n* Agrees to not change their current maintenance methadone dose of 20-200 mg administered as a single daily dose\n\nExclusion Criteria:\n\n* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Is mentally or legally incapacitated, has significant emotional problems at the time of prestudy (screening) visit or expected during the conduct of the study or has a history of clinically significant psychiatric disorder of the last 5 years\n* Has a history of cancer (malignancy)\n* Has a history of significant multiple and/or severe allergies (eg, food, drug, latex) or has had an anaphylactic reaction or significant intolerability (ie, systemic allergic reaction) to prescription or non-prescription drugs or food\n* Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4 weeks prior to the screening visit\n* With the exception of methadone, is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies beginning approximately 2 weeks (or 5 half-lives) prior to the first dose of the 14-day methadone maintenance run-in phase prior to Day 1, throughout the trial, until the AE follow-up call (Day 16)\n* Has participated in another investigational study within 4 weeks (or 5 half-lives) prior to the prestudy (screening) visit.\n* Has a QTc interval \\>450 msec (males) or \\>470 msec (females), has a history of risk factors for Torsades de Pointes (eg, heart failure/cardiomyopathy or family history of long QT syndrome), has uncorrected hypokalemia or hypomagnesemia, is taking concomitant medications that prolong the QT/QTc interval other than methadone\n* Does not limit smoking to no more than 10 cigarettes per day while in the clinical research unit (CRU)\n* Consumes greater than 3 glasses of alcoholic beverages per day\n* Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, energy drinks, or other caffeinated beverages per day\n* With the exception of tetrahydrocannabinol (THC), has a positive screen for drugs with a high potential for abuse such as cocaine, amphetamines, methylenedioxymethamphetamine (MDMA), barbiturates, benzodiazepines (with the exception noted in exclusion criteria 7), or opiates/opioids on Day -1\n* Presents any concern by the investigator regarding safe participation in the study or for any other reason the investigator considers the participant inappropriate for participation in the study'}, 'identificationModule': {'nctId': 'NCT04568603', 'briefTitle': 'Islatravir and Methadone Pharmacokinetics (MK-8591-029)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Clinical Trial to Study the Effect of a Single Dose of Islatravir (MK-8591) on the Pharmacokinetics of Methadone', 'orgStudyIdInfo': {'id': '8591-029'}, 'secondaryIdInfos': [{'id': 'MK-8591-029', 'type': 'OTHER', 'domain': 'MSD Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methadone + ISL', 'description': 'Methadone-maintained participants (20 to 200 mg \\[locally-provided\\] once daily \\[QD\\] from Day -14 to Day -1 and Day 10 to Day 15) receive methadone 20 to 200 mg QD on Day 1 to Day 9; ISL 60 mg is co-administered with methadone on Day 2.', 'interventionNames': ['Drug: Islatravir']}], 'interventions': [{'name': 'Islatravir', 'type': 'DRUG', 'otherNames': ['MK-8591'], 'description': 'ISL 30 mg x 2 (60 mg total) capsules taken by mouth.', 'armGroupLabels': ['Methadone + ISL']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33024', 'city': 'Hollywood', 'state': 'Florida', 'country': 'United States', 'facility': 'Research Centers of America, LLC ( Site 0002)', 'geoPoint': {'lat': 26.0112, 'lon': -80.14949}}, {'zip': '84124', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'PRA Health Sciences ( Site 0001)', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], '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'}}}}