Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-04-16 @ 4:53 PM
Study NCT ID:
NCT02223351
Status:
COMPLETED
Last Update Posted:
2019-02-27
First Post:
2014-08-15
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Drug-Drug Interaction Study: ASP2151 and Ritonavir
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006561', 'term': 'Herpes Simplex'}], 'ancestors': [{'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017193', 'term': 'Skin Diseases, Viral'}, {'id': 'D012874', 'term': 'Skin Diseases, Infectious'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C568714', 'term': 'ASP2151'}, {'id': 'D019438', 'term': 'Ritonavir'}], '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ctinfo@mii.maruho.co.jp', 'phone': '+81-75-325-3255', 'title': 'Maruho Co.,Ltd. Kyoto R&D Center', 'organization': 'Clinical Development Dept.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Up to 31 days after the final dose', 'eventGroups': [{'id': 'EG000', 'title': '400 mg ASP2151 Alone', 'description': '400 mg ASP2151 alone', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 8, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '400 mg ASP2151 With Ritonavir', 'description': '400 mg ASP2151 with 600 mg ritonavir', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 17, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': '1200 mg ASP2151 Alone', 'description': '1200 mg ASP2151 alone', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 15, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': '1200 mg ASP2151 With Ritonavir', 'description': '1200 mg ASP2151 with 600 mg ritonavir', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 13, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Catheter site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Feeling cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Abdominal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Cheilitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Sensitivity of teeth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'joint swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Hyperhidrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Pruritus generalised', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Eye pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Photophobia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 24, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 24, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 24, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA/17.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Peak Plasma Concentration (Cmax) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '1845.7', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '2518.7', 'spread': '21.9', 'groupId': 'OG001'}, {'value': '3804', 'spread': '28.8', 'groupId': 'OG002'}, {'value': '6211.6', 'spread': '29.2', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Time of Peak Concentration (Tmax) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '4', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '10.00'}, {'value': '3.025', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '4.12'}, {'value': '4', 'groupId': 'OG003', 'lowerLimit': '2.00', 'upperLimit': '12.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve (AUC) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '23162.4', 'spread': '34.2', 'groupId': 'OG000'}, {'value': '60225.3', 'spread': '23', 'groupId': 'OG001'}, {'value': '48532.3', 'spread': '29.3', 'groupId': 'OG002'}, {'value': '162131.6', 'spread': '25.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Half-Life (t1/2) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '7.375', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '12.575', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '7.178', 'spread': '17.5', 'groupId': 'OG002'}, {'value': '12.498', 'spread': '19.6', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '18.314', 'spread': '7.2654', 'groupId': 'OG000'}, {'value': '6.815', 'spread': '1.6607', 'groupId': 'OG001'}, {'value': '25.735', 'spread': '7.5753', 'groupId': 'OG002'}, {'value': '7.63', 'spread': '1.9843', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Apparent Volume of Distribution (Vd/F) of ASP2151', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '190.1', 'spread': '56.912', 'groupId': 'OG000'}, {'value': '123.17', 'spread': '28.366', 'groupId': 'OG001'}, {'value': '266.33', 'spread': '79.948', 'groupId': 'OG002'}, {'value': '139.33', 'spread': '43.231', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious and Non-Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': '400 mg ASP2151 alone'}, {'id': 'OG001', 'title': '400 mg ASP2151 With Ritonavir', 'description': '400 mg ASP2151 with 600 mg ritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': '1200 mg ASP2151 alone'}, {'id': 'OG003', 'title': '1200 mg ASP2151 Withritonavir', 'description': '1200 mg ASP2151 with 600 mg ritonavir'}], 'classes': [{'title': 'Non-serious adverse event', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}]}, {'title': 'serious adverse event', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 31 days', 'description': 'Refer to the result of adverse event.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Peak Plasma Concentration (Cmax) of ASP1955888-00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '189.9', 'spread': '27.7', 'groupId': 'OG000'}, {'value': '21.6', 'spread': '70.7', 'groupId': 'OG001'}, {'value': '421.5', 'spread': '36.7', 'groupId': 'OG002'}, {'value': '56.2', 'spread': '79.9', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Time of Peak Concentration (Tmax) of ASP1955888-00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.07'}, {'value': '1.5', 'groupId': 'OG001', 'lowerLimit': '1.00', 'upperLimit': '12.07'}, {'value': '3', 'groupId': 'OG002', 'lowerLimit': '1.98', 'upperLimit': '6.00'}, {'value': '1.01', 'groupId': 'OG003', 'lowerLimit': '0.5', 'upperLimit': '23.98'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)', 'unitOfMeasure': 'h', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Area Under the Curve (AUC) of ASP1955888-00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '2636.2', 'spread': '25.8', 'groupId': 'OG000'}, {'value': '744.4', 'spread': '12', 'groupId': 'OG001'}, {'value': '6023.1', 'spread': '30.2', 'groupId': 'OG002'}, {'value': '1646.1', 'spread': '37.3', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)', 'unitOfMeasure': 'h*ng/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Half-life (t1/2) of ASP1955888-00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '8.063', 'spread': '18.1', 'groupId': 'OG000'}, {'value': '40.213', 'spread': '56.6', 'groupId': 'OG001'}, {'value': '7.617', 'spread': '18.6', 'groupId': 'OG002'}, {'value': '42.197', 'spread': '69.1', 'groupId': 'OG003'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)', 'unitOfMeasure': 'h', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '156.72', 'spread': '43.197', 'groupId': 'OG000'}, {'value': '540.93', 'spread': '68.554', 'groupId': 'OG001'}, {'value': '207.45', 'spread': '59.311', 'groupId': 'OG002'}, {'value': '775.35', 'spread': '315.166', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)', 'unitOfMeasure': 'L/h', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Apparent Volume of Distribution (Vd/F) of ASP1955888-00', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '400 mg ASP2151 Alone', 'description': 'ASP2151(400 mg) alone'}, {'id': 'OG001', 'title': '400mg ASP2151 With Ritonavir', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}, {'id': 'OG002', 'title': '1200 mg ASP2151 Alone', 'description': 'ASP2151(1200 mg) alone'}, {'id': 'OG003', 'title': '1200mg ASP2151 With Ritonavir', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir\n\nASP2151\n\nritonavir'}], 'classes': [{'categories': [{'measurements': [{'value': '1840.8', 'spread': '559.49', 'groupId': 'OG000'}, {'value': '21474', 'spread': '4135.72', 'groupId': 'OG001'}, {'value': '2340.7', 'spread': '877.14', 'groupId': 'OG002'}, {'value': '27624.2', 'spread': '14413.73', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)', 'unitOfMeasure': 'L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '400mg ASP2151', 'description': 'ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa.'}, {'id': 'FG001', 'title': '1200mg ASP2151', 'description': 'ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'First Intervention (8 Days)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Wasout (2weeks)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'Second Intervention (8 Days)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at one investigative site in United Kingdom from 05-September 2014 to 04-December 2014'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '400mg ASP2151', 'description': 'ASP2151 400mg alone followed by ASP2151 400mg + 600 mg ritonavir, or vice versa.'}, {'id': 'BG001', 'title': '1200mg ASP2151', 'description': 'ASP2151 1200mg alone followed by ASP2151 1200mg + 600 mg ritonavir, or vice versa.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '28.2', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '27', 'spread': '4.9', 'groupId': 'BG001'}, {'value': '27.6', 'spread': '5.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'year', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-25', 'studyFirstSubmitDate': '2014-08-15', 'resultsFirstSubmitDate': '2018-07-09', 'studyFirstSubmitQcDate': '2014-08-20', 'lastUpdatePostDateStruct': {'date': '2019-02-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-07-09', 'studyFirstPostDateStruct': {'date': '2014-08-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of ASP1955888-00', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)'}, {'measure': 'Time of Peak Concentration (Tmax) of ASP1955888-00', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)'}, {'measure': 'Area Under the Curve (AUC) of ASP1955888-00', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)'}, {'measure': 'Half-life (t1/2) of ASP1955888-00', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)'}, {'measure': 'Apparent Total Body Clearance (CL/F) From Plasma of ASP1955888-00', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of ASP1955888-00', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention', 'description': 'ASP1955888-00 is a metabolite of the study drug (ASP2151)'}], 'primaryOutcomes': [{'measure': 'Peak Plasma Concentration (Cmax) of ASP2151', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention'}, {'measure': 'Time of Peak Concentration (Tmax) of ASP2151', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention'}, {'measure': 'Area Under the Curve (AUC) of ASP2151', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention'}, {'measure': 'Half-Life (t1/2) of ASP2151', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention'}, {'measure': 'Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention'}, {'measure': 'Apparent Volume of Distribution (Vd/F) of ASP2151', 'timeFrame': 'Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Serious and Non-Serious Adverse Events', 'timeFrame': 'Up to 31 days', 'description': 'Refer to the result of adverse event.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HSV', 'HIV', 'Herpes', 'volunteers', 'drug-drug interaction'], 'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to contracting other infections because of their compromised immune system. As HIV patients will be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one of the drugs that is commonly prescribed to HIV patients (ritonavir).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers\n* Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.\n* Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.\n\nExclusion Criteria:\n\n* Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.\n* Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).\n* Platelet counts outside normal limits.\n* Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.\n* Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.\n* History of bleeding diathesis.\n* Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.\n* Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as \\>3), or sensitivity to trial medication.\n* Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4 metabolic pathway (unless judged as not clinical significant by the investigator and sponsor).\n* Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen).\n* Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.\n* Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.\n* Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 10 cigarettes daily.\n* Evidence of drug abuse on urine testing.\n* Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.\n* Blood pressure (BP) and heart rate (HR) in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40\\_100 beats/min."}, 'identificationModule': {'nctId': 'NCT02223351', 'briefTitle': 'Drug-Drug Interaction Study: ASP2151 and Ritonavir', 'organization': {'class': 'INDUSTRY', 'fullName': 'Maruho Europe Limited'}, 'officialTitle': 'A Single-centre, Open-label, Randomised, Crossover, Drug-drug Interaction Study to Investigate the Effect of a Single Oral Dose of Ritonavir on the Single Dose Pharmacokinetics of ASP2151 in Healthy Men', 'orgStudyIdInfo': {'id': 'M522101-EU22'}, 'secondaryIdInfos': [{'id': '2014-002174-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '400mg ASP2151', 'description': '400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir', 'interventionNames': ['Drug: ASP2151', 'Drug: ritonavir']}, {'type': 'OTHER', 'label': '1200mg ASP2151', 'description': '1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir', 'interventionNames': ['Drug: ASP2151', 'Drug: ritonavir']}], 'interventions': [{'name': 'ASP2151', 'type': 'DRUG', 'armGroupLabels': ['1200mg ASP2151', '400mg ASP2151']}, {'name': 'ritonavir', 'type': 'DRUG', 'otherNames': ['Norvir'], 'armGroupLabels': ['1200mg ASP2151', '400mg ASP2151']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'NW10 7EW', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Hammersmith Medicines Research Ltd', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maruho Europe Limited', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}