Ignite Creation Date:
2025-12-24 @ 9:20 PM
Ignite Modification Date:
2025-12-25 @ 7:07 PM
Study NCT ID:
NCT03537404
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2018-05-15
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}, {'id': 'D060085', 'term': 'Coinfection'}], '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'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552043', 'term': 'narlaprevir'}, {'id': 'D019438', 'term': 'Ritonavir'}, {'id': 'D000068698', 'term': 'Tenofovir'}, {'id': 'D000068898', 'term': 'Raltegravir Potassium'}], 'ancestors': [{'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D063065', 'term': 'Organophosphonates'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D000225', 'term': 'Adenine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D011760', 'term': 'Pyrrolidinones'}, {'id': 'D011759', 'term': 'Pyrrolidines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'krasavina@rpharm.ru', 'phone': '0074959567937', 'title': 'Emiliya Krasavina, Medical Adviser', 'organization': 'R-Pharm'}, 'certainAgreement': {'otherDetails': 'Any study related information could be made public availiable only after Sponsors written permission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B (Part 1)', 'description': 'Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nTenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 4, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment A (Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Treatment B (Part 2)', 'description': 'Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment C (Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nRaltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 1, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Alanine Aminotransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 19.0'}, {'term': 'Blood Lactate Dehydrogenase Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 19.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 19.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 19.0'}, {'term': 'Gamma-Glutamyltransferase Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedRA 19.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cmax of Narlaprevir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Part 1)', 'description': 'Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).'}, {'id': 'OG001', 'title': 'Treatment C (Part 1)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).'}, {'id': 'OG002', 'title': 'Treatment A (Part 2)', 'description': 'Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).'}, {'id': 'OG003', 'title': 'Treatment C (Part 2)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '2130.2742', 'groupId': 'OG000', 'lowerLimit': '1817.4088', 'upperLimit': '2731.8348'}, {'value': '2172.233', 'groupId': 'OG001', 'lowerLimit': '1895.673', 'upperLimit': '2726.557'}, {'value': '2946.131', 'groupId': 'OG002', 'lowerLimit': '2617.485', 'upperLimit': '3799.642'}, {'value': '2880.612', 'groupId': 'OG003', 'lowerLimit': '2412.858', 'upperLimit': '4121.871'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.020', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '0.142', 'estimateComment': 'Cmax parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.022', 'ciLowerLimit': '-0.220', 'ciUpperLimit': '0.175', 'estimateComment': 'Cmax parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)', 'description': 'Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study', 'unitOfMeasure': 'ng/ml', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'AUCtau of Narlaprevir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Part 1)', 'description': 'Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).'}, {'id': 'OG001', 'title': 'Treatment C (Part 1)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).'}, {'id': 'OG002', 'title': 'Treatment A (Part 2)', 'description': 'Subjects in both Parts of the study recieved as Treatment A for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) and Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily).'}, {'id': 'OG003', 'title': 'Treatment C (Part 2)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '20504.31', 'groupId': 'OG000', 'lowerLimit': '18265.63', 'upperLimit': '24328.95'}, {'value': '21366.2', 'groupId': 'OG001', 'lowerLimit': '18664.1', 'upperLimit': '26481.9'}, {'value': '26199.19', 'groupId': 'OG002', 'lowerLimit': '23136.15', 'upperLimit': '33132.53'}, {'value': '24458.48', 'groupId': 'OG003', 'lowerLimit': '20738.76', 'upperLimit': '33597.42'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.041', 'ciLowerLimit': '-0.075', 'ciUpperLimit': '0.157', 'estimateComment': 'AUCtau parameters were logarithmically transformed.', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.069', 'ciLowerLimit': '-0.201', 'ciUpperLimit': '0.064', 'estimateComment': 'AUCtau parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)', 'description': 'Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Cmax of Tenofovir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment B (Part 1)', 'description': 'Subjects recieved as Treatment B for 5 days (in respective treatment period):\n\nTenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).'}, {'id': 'OG001', 'title': 'Treatment C (Part 1)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '263.037', 'groupId': 'OG000', 'lowerLimit': '233.126', 'upperLimit': '313.318'}, {'value': '344.796', 'groupId': 'OG001', 'lowerLimit': '302.457', 'upperLimit': '415.092'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.271', 'ciLowerLimit': '0.159', 'ciUpperLimit': '0.383', 'estimateComment': 'Cmax parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)', 'description': 'Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study', 'unitOfMeasure': 'ng/ml', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'AUCtau of Tenofovir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment B (Part 1)', 'description': 'Subjects recieved as Treatment B for 5 days (in respective treatment period):\n\nTenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).'}, {'id': 'OG001', 'title': 'Treatment C (Part 1)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily) and Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '2599.95', 'groupId': 'OG000', 'lowerLimit': '2325.72', 'upperLimit': '3043.02'}, {'value': '2799.72', 'groupId': 'OG001', 'lowerLimit': '2536.67', 'upperLimit': '3205.65'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '0.074', 'ciLowerLimit': '0.016', 'ciUpperLimit': '0.132', 'estimateComment': 'AUCtau parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)', 'description': 'Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'Cmax of Raltegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment B (Part 2)', 'description': 'Subjects recieved as Treatment B for 5 days (in respective treatment period):\n\nRaltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).'}, {'id': 'OG001', 'title': 'Treatment C (Part 2)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '830.204', 'groupId': 'OG000', 'lowerLimit': '520.042', 'upperLimit': '2758.109'}, {'value': '715.726', 'groupId': 'OG001', 'lowerLimit': '136.163', 'upperLimit': '2396.130'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.148', 'ciLowerLimit': '-0.450', 'ciUpperLimit': '0.153', 'estimateComment': 'Cmax parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)', 'description': 'Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study', 'unitOfMeasure': 'ng/ml', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug.'}, {'type': 'PRIMARY', 'title': 'AUCtau of Raltegravir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment B (Part 2)', 'description': 'Subjects recieved as Treatment B for 5 days (in respective treatment period):\n\nRaltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).'}, {'id': 'OG001', 'title': 'Treatment C (Part 2)', 'description': 'Subjects recieved as Treatment C for 5 days (in respective treatment period):\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily) coadministered with Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily and Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os twice daily).'}], 'classes': [{'categories': [{'measurements': [{'value': '2912.45', 'groupId': 'OG000', 'lowerLimit': '1983.01', 'upperLimit': '8451.44'}, {'value': '2653.65', 'groupId': 'OG001', 'lowerLimit': '1033.88', 'upperLimit': '6964.58'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '-0.093', 'ciLowerLimit': '-0.354', 'ciUpperLimit': '0.168', 'estimateComment': 'AUCtau parameters were logarithmically transformed', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)', 'description': 'Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study', 'unitOfMeasure': 'ng*h/ml', 'dispersionType': '90% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days'}, {'id': 'OG001', 'title': 'Treatment B (Part 1)', 'description': 'Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days'}, {'id': 'OG002', 'title': 'Treatment C (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nTenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days'}, {'id': 'OG003', 'title': 'Treatment A (Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days'}, {'id': 'OG004', 'title': 'Treatment B (Part 2)', 'description': 'Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days'}, {'id': 'OG005', 'title': 'Treatment C (Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nRaltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '1', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Changes in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}, {'value': '18', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days'}, {'id': 'OG001', 'title': 'Treatment B (Part 1)', 'description': 'Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days'}, {'id': 'OG002', 'title': 'Treatment C (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nTenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days'}, {'id': 'OG003', 'title': 'Treatment A (Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days'}, {'id': 'OG004', 'title': 'Treatment B (Part 2)', 'description': 'Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days'}, {'id': 'OG005', 'title': 'Treatment C (Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nRaltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'description': 'There were no subjects with abnormal changes in vital signs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Abnormal Laboratory Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days'}, {'id': 'OG001', 'title': 'Treatment B (Part 1)', 'description': 'Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days'}, {'id': 'OG002', 'title': 'Treatment C (Part 1)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily\n\ncoadministered with\n\nRitonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily\n\nand\n\nTenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days'}], 'classes': [{'title': 'Part 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Part 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug separately for each Patr of the study'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Abnormal ECG Changes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A (Part 1/Part 2)', 'description': 'Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily in combination with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily for 5 days'}, {'id': 'OG001', 'title': 'Treatment B (Part 1/Part 2)', 'description': 'Part 1: Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days\n\nPart 2: Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days'}, {'id': 'OG002', 'title': 'Treatment C (Part 1/Part 2)', 'description': 'Part 1: Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Tenofovir Disoproxil Fumarate, 300 mg, film-coated tablets, taken as 300 mg per os daily for 5 days\n\nPart 2: Narlaprevir, 100 mg, film-coated tablets, taken as 200 mg per os daily coadministered with Ritonavir, 100 mg, film-coated tablets, taken as 100 mg per os daily and Raltegravir, 400 mg, film-coated tablets, taken as 400 mg per os daily for 5 days'}], 'classes': [{'title': 'Part 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Part 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'description': 'There were no subjects with abnormal ECG changes during the study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized to study treatment and received at least one dose of study drug'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part 1', 'description': 'All patients of Part 1 of the study were randomized in 1:1:1 ratio to receive one of the treatment sequences (A/B/C, B/C/A or C/A/B). Every subject received only one drug combination (A or B or C) in one treatment period. Each period was followed by 8 washout days. Treatments include:\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily); Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily); Tenofovir Disoproxil Fumarate (300 mg, film-coated tablets, taken as 300 mg per os once daily) in different combinations assigned to the subjects in accordance with protocol considerations for Part 1 of the study.'}, {'id': 'FG001', 'title': 'Part 2', 'description': 'All patients of Part 2 of the study were randomized in 1:1:1 ratio to receive one of the treatment sequences (A/B/C, B/C/A or C/A/B). Every subject received only one drug combination (A or B or C) in one treatment period. Each period was followed by 8 washout days. Treatments include:\n\nNarlaprevir (100 mg, film-coated tablets, taken as 200 mg per os once daily); Ritonavir (100 mg, film-coated tablets, taken as 100 mg per os once daily); Raltegravir (400 mg, film-coated tablets, taken as 400 mg per os once daily) in different combinations assigned to the subjects in accordance with protocol considerations for Part 2 of the study.'}], 'periods': [{'title': 'First Intervention (A or B or C)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'First Washout Period (8 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Intervention (A or B or C)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Second Washout Period (8 Days)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Third Intervention (A or B or C)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Healthy adult volunteers were recruited for all Parts of the study in one clinical site (Bessalar clinic) in Moscow between April and June 2017. 36 subjects were randomized so that 18 subjects participated in each Part of the study (6 subjects in each treatment group of each Part).', 'preAssignmentDetails': 'Subjects were to be screened within 28 days before dosing in this multi-part study. Subjects were to be admitted to the study center the evening before the first dose for baseline assessments to confirm eligibility.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '36', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence A/B/C', 'description': 'All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:\n\nTreatment period 1 - Treatment A Treatment period 2 - Treatment B Treatment period 3 - Treatment C'}, {'id': 'BG001', 'title': 'Sequence B/C/A', 'description': 'All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:\n\nTreatment period 1 - Treatment B Treatment period 2 - Treatment C Treatment period 3 - Treatment A'}, {'id': 'BG002', 'title': 'Sequence C/A/B', 'description': 'All participants of Part 1 or 2 of the study randomized in this group received treatment combinations (according to the protocol allocation) in the following sequence:\n\nTreatment period 1 - Treatment C Treatment period 2 - Treatment A Treatment period 3 - Treatment B'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24.3', 'spread': '1.75', 'groupId': 'BG000'}, {'value': '38.3', 'spread': '8.26', 'groupId': 'BG001'}, {'value': '29.7', 'spread': '1.86', 'groupId': 'BG002'}, {'value': '30.8', 'spread': '7.57', 'groupId': 'BG003'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24.3', 'spread': '4.03', 'groupId': 'BG000'}, {'value': '38.7', 'spread': '4.59', 'groupId': 'BG001'}, {'value': '29.5', 'spread': '3.33', 'groupId': 'BG002'}, {'value': '30.8', 'spread': '7.17', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).'}, {'title': 'Sex: Female, Male', 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Black', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'Part 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '23.14', 'spread': '1.287', 'groupId': 'BG000'}, {'value': '24.73', 'spread': '3.022', 'groupId': 'BG001'}, {'value': '24.20', 'spread': '3.134', 'groupId': 'BG002'}, {'value': '24.02', 'spread': '2.554', 'groupId': 'BG003'}]}]}, {'title': 'Part 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '18', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24.26', 'spread': '4.132', 'groupId': 'BG000'}, {'value': '25.40', 'spread': '2.732', 'groupId': 'BG001'}, {'value': '25.63', 'spread': '3.408', 'groupId': 'BG002'}, {'value': '25.10', 'spread': '3.319', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Calculated as weight(kg)/height(m\\^2)', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Baseline characteristics analisys was performed separately for Part 1 and 2 of the study (18 subjects in each Part were randomized in 1:1:1 ratio for each treatment sequence - 6 participants in each).'}], 'populationDescription': 'All 36 subjects randomized to study treatment and received at least one dose of study drug (Safety Population).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-02-20', 'size': 636036, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-08-28T03:26', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-31', 'studyFirstSubmitDate': '2018-05-15', 'resultsFirstSubmitDate': '2018-08-31', 'studyFirstSubmitQcDate': '2018-05-15', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-31', 'studyFirstPostDateStruct': {'date': '2018-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cmax of Narlaprevir', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)', 'description': 'Maximum observed Concentration of Narlaprevir at Day 5 of treatment A and C of Part 1 or 2 of the study'}, {'measure': 'AUCtau of Narlaprevir', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16 and 24 hours post-dose on Day 5 of treatment A and C (Part 1/ Part 2)', 'description': 'Area Under the Concentration-time curve during a dosing interval τ at steady state of Narlaprevir at Day 5 of treatment A and C of Part 1/ Part 2 of the study'}, {'measure': 'Cmax of Tenofovir', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)', 'description': 'Maximum observed Concentration of Tenofovir at Day 5 of treatment B and C of Part 1 of the study'}, {'measure': 'AUCtau of Tenofovir', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 18 and 24 hrs post-dose on Day 5 of treatment B and C (Part 1)', 'description': 'Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 1 of the study'}, {'measure': 'Cmax of Raltegravir', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)', 'description': 'Maximum observed Concentration of Raltegravir at Day 5 of treatment B and C of Part 2 of the study'}, {'measure': 'AUCtau of Raltegravir', 'timeFrame': 'Day 5 Pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 12 hrs post-dose of Day 5 of treatment B and C (Part 2)', 'description': 'Area Under the Concentration-time curve during a dosing interval τ at steady state of Tenofovir at Day 5 of treatment B and C of Part 2 of the study'}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Adverse Events', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study'}, {'measure': 'Number of Patients With Changes in Vital Signs', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'description': 'There were no subjects with abnormal changes in vital signs'}, {'measure': 'Number of Patients With Abnormal Laboratory Values', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study'}, {'measure': 'Number of Patients With Abnormal ECG Changes', 'timeFrame': 'Up to 14 Days after the last dose of treatment in period 3 of each Part of the Study', 'description': 'There were no subjects with abnormal ECG changes during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hepatitis C', 'chronic', 'pharmacokinetics', 'HIV', 'coinfection', 'concomitant therapy'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The study purpose is to evaluate the potential for a pharmacokinetic drug-drug interaction, safety and tolerability when Narlaprevir, Ritonavir (used as a metabolic inhibitor) and Tenofovir disoproxil fumarate (part 1) and Narlaprevir, Ritonavir and Raltegravir (part 2) are administered in combination to healthy volunteers.', 'detailedDescription': 'The current study includes 2 parts, as the following drugs may be used concomitantly to treat hepatitis C virus (HCV)/HIV coinfection:\n\n* Part 1 of the study is being conducted to evaluate the pharmacokinetic effect of coadministration of narlaprevir with ritonavir and tenofovir disoproxil fumarate.\n* Part 2 of the study is being conducted to evaluate the pharmacokinetic effect of coadministration of narlaprevir/ritonavir and raltegravir.\n\nEach part of the study is designed as a randomized 3-period crossover study and will assess if there is any effect of tenofovir disoproxil fumarate or raltegravir on the pharmacokinetics of narlaprevir and vice versa.\n\nSubjects will be screened within 28 days before dosing in this multi-part study. All subjects eligible for protocol criteria will be randomized 1:1:1 to receive one of the following treatment sequences: A/B/C, or B/C/A, or C/A/B. Every subject will receive only one treatment (A or B or C) in one Period. Subjects will be confined to the study center throughout treatment in each period. Following completion of study procedures for each treatment period, subjects will be released from the clinic. After a 7-14 (maximum) days interval between dosing, subjects will return to start hospitalization for the next treatment period. Subjects will be discharged from the study upon completion of all study related procedures in Period 3. Phone call will be conducted after 5-7 days of follow-up period to assess safety data.\n\nThis drug interaction study is designed to investigate pharmacokinetic drug-drug interactions between Narlaprevir coadministered with Ritonavir and antiretroviral drugs (Tenofovir disoproxil fumarate and Raltegravir) for labeling and clinical dosing guidance purposes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria (the subject must meet all the criteria listed below for entry at baseline and at Days -1 and 1 before each treatment Period):\n\n* Subjects must be willing to give written informed consent for the trial and able to adhere to dose and visit schedules.\n* Subjects having a Body Mass Index (BMI) between 18,5 and 30 kg/m\\^2, inclusive.\n* Subjects should diagnosed as "healthy": no pathology of the gastrointestinal tract, liver, kidneys, cardiovascular system, central nervous system (previously carried out by standard clinical and lab tests which did not reveal the presence of any diseases. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) must not exceed the normal range; QT interval calculated by Bazett\'s formula (QTcB) for men should be ≤ 450 ms and ≤ 470 ms for women, the interval PR should be ≤ 200 ms).\n* Vital sign measurements (taken after \\~3 minutes in a supine or sitting position) must be within the following ranges:\n\n 1. systolic blood pressure, 100 - 130 mm Hg;\n 2. diastolic blood pressure, 60 -90 mm Hg;\n 3. pulse rate, 60-80 bpm.\n* Female subjects must be:\n\n 1. postmenopausal (defined as 12 months with no menses; age \\> 40 years and with a follicle-stimulating hormone (FSH) level of \\>40 u/mL);\n 2. surgically sterilized at least 3 months prior to baseline (e.g., documented hysterectomy or tubal ligation).\n* Men must agree to use a medically accepted method of contraception (condom and spermicide) during the trial and for 3 months after stopping the medication.\n\nExclusion Criteria (the subject will be excluded from entry if any of the criteria listed below are met at baseline):\n\n* Females with childbearing potential.\n* Subjects who, in the opinion of the investigator, will not be able to participate optimally in the study.\n* Positive results for hepatitis B surface antigen, hepatitis C antibodies or HIV, positive RW results.\n* Allergic reactions in history.\n* Intolerance to medication.\n* Chronic disease of cardiovascular, bronchopulmonary, and/or neuroendocrine systems, gastrointestinal, liver, pancreas, kidney and/or blood disease.\n* History or presence of impaired renal function, lactase deficiency, lactose intolerance, glucose-galactose malabsorption.\n* History of urinary obstruction or difficulty in voiding.\n* Gastrointestinal surgery in history (except of appendectomy).\n* Acute infections less than 4 weeks before participation in the study.\n* Subjects with a medical history of osteopenia and/or osteoporosis.\n* Regular administration of any medicines less than 4 weeks before participation in the study.\n* Administration of medicines with marked influence on hemodynamics, liver function et al (barbiturates, omeprazole, cimetidine et al) less than 30 days before participation in the study.\n* Blood donation (450 ml or more of blood or plasma) less than 2 months before participation in the study.\n* Intake of more than 10 units of alcohol in a week (1 unit of alcohol is equal to 0.5 L of beer, 200 mL of wine or 50 mL of spirits) or history of drug abuse or alcoholism.\n* Smoking of more than 10 cigarettes or equivalent tobacco use per day.\n* Participation in phase 1 clinical trial less than 3 months before participation in the study.\n* Positive screen for drugs abuse and drugs use.\n* Subjects with a medical history of psychiatric or personality disorders that in the opinion of the investigator and sponsor, affects the subject\'s ability to participate in the trial.\n* Subjects who are part of the study staff personnel or family members of the study staff personnel.'}, 'identificationModule': {'nctId': 'NCT03537404', 'briefTitle': 'A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs', 'organization': {'class': 'INDUSTRY', 'fullName': 'R-Pharm'}, 'officialTitle': 'A Drug Interaction Study to Assess the Pharmacokinetics of Narlaprevir and Antiretroviral Drugs', 'orgStudyIdInfo': {'id': 'CJ05013019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment A (Part 1/ Part 2)', 'description': 'Narlaprevir 200 mg once daily with Ritonavir 100 mg once daily for 5 days', 'interventionNames': ['Drug: Narlaprevir', 'Drug: Ritonavir']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B (Part 1)', 'description': 'Tenofovir disoproxil fumarate 300 mg once daily for 5 days', 'interventionNames': ['Drug: Tenofovir Disoproxil Fumarate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment B (Part 2)', 'description': 'Raltegravir 400 mg twice daily for 5 days', 'interventionNames': ['Drug: Raltegravir']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C (Part 1)', 'description': 'Narlaprevir 200 mg once daily coadministered with ritonavir 100 mg once daily and Tenofovir disoproxil fumarate 300 mg once daily for 5 days', 'interventionNames': ['Drug: Narlaprevir', 'Drug: Ritonavir', 'Drug: Tenofovir Disoproxil Fumarate']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C (Part 2)', 'description': 'Narlaprevir 200 mg once daily coadministered with ritonavir 100 mg once daily and 400 mg raltegravir twice daily for 5 days', 'interventionNames': ['Drug: Narlaprevir', 'Drug: Ritonavir', 'Drug: Raltegravir']}], 'interventions': [{'name': 'Narlaprevir', 'type': 'DRUG', 'otherNames': ['Arlansa'], 'description': '100 mg, film-coated tablets, taken as 200 mg per os daily', 'armGroupLabels': ['Treatment A (Part 1/ Part 2)', 'Treatment C (Part 1)', 'Treatment C (Part 2)']}, {'name': 'Ritonavir', 'type': 'DRUG', 'otherNames': ['Norvir'], 'description': '100 mg, film-coated tablets, taken as 100 mg per os daily', 'armGroupLabels': ['Treatment A (Part 1/ Part 2)', 'Treatment C (Part 1)', 'Treatment C (Part 2)']}, {'name': 'Tenofovir Disoproxil Fumarate', 'type': 'DRUG', 'otherNames': ['Tenofovir-TL', 'Viread'], 'description': '300 mg, film-coated tablets, taken as 300 mg per os daily', 'armGroupLabels': ['Treatment B (Part 1)', 'Treatment C (Part 1)']}, {'name': 'Raltegravir', 'type': 'DRUG', 'otherNames': ['Isentress'], 'description': '400 mg, film-coated tablets, taken as 400 mg per os daily', 'armGroupLabels': ['Treatment B (Part 2)', 'Treatment C (Part 2)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Moscow', 'country': 'Russia', 'facility': 'Clinic "Bessalar" JSC', 'geoPoint': {'lat': 55.75204, 'lon': 37.61781}}], 'overallOfficials': [{'name': 'Mikhail Samsonov', 'role': 'STUDY_DIRECTOR', 'affiliation': 'R-Pharm'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'R-Pharm', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Almedis', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}