Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-04-21 @ 10:42 PM
Study NCT ID:
NCT02392494
Status:
COMPLETED
Last Update Posted:
2019-01-22
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Belgium', 'Moldova']}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialsDisclosure@merck.com', 'phone': '1-800-672-6372', 'title': 'Senior Vice President, Global Clinical Development', 'organization': 'Merck Sharp & Dohme Corp.'}, 'certainAgreement': {'otherDetails': 'The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission; this confidentiality does not include efficacy and safety results. Sponsor review can be expedited to meet publication timelines.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to study day 14', 'description': 'APaT: all participants who received at least 1 dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Procedural pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Experiencing an Adverse Event (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.'}, {'id': 'OG001', 'title': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.'}, {'id': 'OG002', 'title': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.'}], 'classes': [{'categories': [{'measurements': [{'value': '66.7', 'groupId': 'OG000'}, {'value': '66.7', 'groupId': 'OG001'}, {'value': '33.3', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Study Day 14', 'description': "An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All Participants as Treated (APaT): all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants Who Discontinued Study Due to an AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.'}, {'id': 'OG001', 'title': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.'}, {'id': 'OG002', 'title': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Study Day 14', 'description': "An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel.", 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'APaT: all participants who received at least 1 dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.'}, {'id': 'OG001', 'title': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.'}, {'id': 'OG002', 'title': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.'}], 'classes': [{'title': 'Baseline HCV RNA', 'categories': [{'measurements': [{'value': '5.72', 'spread': '0.016', 'groupId': 'OG000'}, {'value': '6.837', 'spread': '0.145', 'groupId': 'OG001'}, {'value': '6.31', 'spread': '0.336', 'groupId': 'OG002'}]}]}, {'title': 'Maximum HCV RNA Change', 'categories': [{'measurements': [{'value': '0.673', 'spread': '0.078', 'groupId': 'OG000'}, {'value': '1.15', 'spread': '0.315', 'groupId': 'OG001'}, {'value': '1.593', 'spread': '0.134', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose', 'description': 'For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.', 'unitOfMeasure': 'log(IU/ml)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol (PP) Population: all participants who received at least 1 dose of study drug and who complied with the protocol'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.'}, {'id': 'FG001', 'title': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.'}, {'id': 'FG002', 'title': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.'}, {'id': 'FG003', 'title': 'MK-1075 800 mg (Panel D)', 'description': 'HCV-infected participants were to receive a single 800 mg dose of MK-1075. No participants were enrolled in this arm.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Nine participants were enrolled and allocated to single doses of either 100, 200, or 400 mg of MK-1075. As per the protocol, planned Panel D (800 mg MK-1075) was not enrolled since the study objective was achieved in Panel C.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.'}, {'id': 'BG001', 'title': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.'}, {'id': 'BG002', 'title': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.7', 'spread': '15.7', 'groupId': 'BG000'}, {'value': '44.0', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '49.7', 'spread': '2.5', 'groupId': 'BG002'}, {'value': '47.4', 'spread': '9.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'In each panel (A, B, C, and D), participants will receive a single dose of MK-1075 (100, 200, 400, and 800 mg, respectively) in a fasted state. Safety and viral load (VL) data from the previous panel will be assessed before dosing the subsequent panel.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2015-08-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2015-03-16', 'resultsFirstSubmitDate': '2018-05-30', 'studyFirstSubmitQcDate': '2015-03-16', 'lastUpdatePostDateStruct': {'date': '2019-01-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-05-30', 'studyFirstPostDateStruct': {'date': '2015-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Experiencing an Adverse Event (AE)', 'timeFrame': 'Up to Study Day 14', 'description': "An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that experienced an AE was reported for each treatment panel."}, {'measure': 'Percentage of Participants Who Discontinued Study Due to an AE', 'timeFrame': 'Up to Study Day 14', 'description': "An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that was temporally associated with the use of the Sponsor's product, was also an AE. The percentage of participants that discontinued the study due to an AE was reported for each treatment panel."}, {'measure': 'Maximum HCV Viral Load (VL) Change From Baseline Over Time Following Single-Dose MK-1075', 'timeFrame': 'Pre-dose (baseline), 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose', 'description': 'For assessment of antiviral activity of MK-1075 at each study dose, baseline and post-dose HCV ribonucleic acid (RNA) (log10) were measured at pre-dose and 2, 4, 8, 12, 16, 24, 32, 48, 72, and 120 hours post-dose. For each participant, baseline measurement was defined as the measurement obtained pre-dose on the first day of dosing. The estimated change from baseline in HCV RNA VL (log10) was calculated for each participant by time point after each single dose, and the maximum change (reduction) in HCV RNA was determined and reported for each treatment arm using an Analysis of Variance (ANOVA) model.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and pharmacokinetics of MK-1075, and to determine the ability of MK-1075 to reduce HCV viral load, following administration of a single dose in HCV-infected participants.', 'detailedDescription': 'Per protocol, panels may be omitted if the objectives of the study are met in preceding panels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female of non-child bearing potential\n* In good health other than HCV genotype (GT) 1 infection\n\nExclusion Criteria:\n\n* Is mentally incapacitated or legally institutionalized\n* Has a history of clinically significant and not stably controlled endocrine, gastrointestinal, cardiovascular, hematological, hepatic (excepting HCV infection), immunological, renal, respiratory, genitourinary or major neurological (including stroke and chronic seizures) abnormalities or diseases\n* Has a history of cancer\n* Is positive for hepatitis B surface antigen (HBsAg) or human immunodeficiency virus (HIV)\n* Has participated in another investigational trial within 4 weeks (or 5 half-lives) prior to Screening\n* Consumes \\>2 alcoholic beverages a day or uses illegal drugs\n* Has evidence or history of chronic hepatitis not caused by HCV including but not limited to non-HCV viral hepatitis, non-alcoholic steatohepatitis (NASH), drug-induced hepatitis, or autoimmune hepatitis\n* Has clinical or laboratory evidence of advanced or decompensated liver disease, evidence of bridging fibrosis or higher grade fibrosis (Metavir score ≥3) from prior liver biopsy'}, 'identificationModule': {'nctId': 'NCT02392494', 'briefTitle': 'Evaluation of MK-1075 in Participants With Hepatitis C Virus (HCV) Infection (MK-1075-002)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Single Rising Dose Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of MK-1075 in HCV-Infected Patients', 'orgStudyIdInfo': {'id': '1075-002'}, 'secondaryIdInfos': [{'id': '2015-000127-93', 'type': 'EUDRACT_NUMBER'}, {'id': 'MK-1075-002', 'type': 'OTHER', 'domain': 'Merck Protocol Number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MK-1075 100 mg (Panel A)', 'description': 'HCV-infected participants receive a single 100 mg dose of MK-1075.', 'interventionNames': ['Drug: MK-1075']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1075 200 mg (Panel B)', 'description': 'HCV-infected participants receive a single 200 mg dose of MK-1075.', 'interventionNames': ['Drug: MK-1075']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1075 400 mg (Panel C)', 'description': 'HCV-infected participants receive a single 400 mg dose of MK-1075.', 'interventionNames': ['Drug: MK-1075']}, {'type': 'EXPERIMENTAL', 'label': 'MK-1075 800 mg (Panel D)', 'description': 'HCV-infected participants receive a single 800 mg dose of MK-1075.', 'interventionNames': ['Drug: MK-1075']}], 'interventions': [{'name': 'MK-1075', 'type': 'DRUG', 'description': 'MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.', 'armGroupLabels': ['MK-1075 100 mg (Panel A)', 'MK-1075 200 mg (Panel B)', 'MK-1075 400 mg (Panel C)', 'MK-1075 800 mg (Panel D)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Merck Sharp & Dohme LLC'}]}, 'ipdSharingStatementModule': {'url': 'http://engagezone.msd.com/ds_documentation.php', 'ipdSharing': 'YES', 'description': 'https://www.merck.com/clinical-trials/pdf/ProcedureAccessClinicalTrialData.pdf'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}