Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-30 @ 7:56 AM
Study NCT ID:
NCT04550234
Status:
COMPLETED
Last Update Posted:
2023-05-10
First Post:
2020-09-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000493', 'term': 'Allopurinol'}, {'id': 'C000628929', 'term': 'verinurad'}], 'ancestors': [{'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Lead', 'organization': 'AstraZeneca Clinical study Information Center'}, 'certainAgreement': {'otherDetails': 'No unpublished information contained herein may be disclosed without prior written approval from AstraZeneca AB. Access to this document must be restricted to relevant parties.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 8, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 6, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Treatment 5', 'description': 'Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 2, 'seriousNumAtRisk': 25, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Eye pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Swelling of eyelid', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Lip blister', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Feeling hot', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}, {'term': 'Arthropod bite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 25, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 25, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Cmax: Maximum Observed Plasma Drug Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '26.62', 'spread': '50.71', 'groupId': 'OG000'}, {'value': '34.95', 'spread': '61.87', 'groupId': 'OG001'}, {'value': '20.18', 'spread': '70.96', 'groupId': 'OG002'}, {'value': '13.86', 'spread': '68.98', 'groupId': 'OG003'}, {'value': '35.35', 'spread': '44.84', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '1526', 'spread': '37.98', 'groupId': 'OG000'}, {'value': '1471', 'spread': '42.92', 'groupId': 'OG001'}, {'value': '1079', 'spread': '68.87', 'groupId': 'OG002'}, {'value': '1627', 'spread': '43.71', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '6376', 'spread': '16.67', 'groupId': 'OG000'}, {'value': '6066', 'spread': '21.61', 'groupId': 'OG001'}, {'value': '5269', 'spread': '19.91', 'groupId': 'OG002'}, {'value': '5709', 'spread': '21.21', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '57.73', 'ciLowerLimit': '47.07', 'ciUpperLimit': '70.81', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '145.55', 'ciLowerLimit': '118.66', 'ciUpperLimit': '178.52', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '52.07', 'ciLowerLimit': '42.46', 'ciUpperLimit': '63.87', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '101.16', 'ciLowerLimit': '82.48', 'ciUpperLimit': '124.08', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '73.34', 'ciLowerLimit': '61.81', 'ciUpperLimit': '87.03', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '66.33', 'ciLowerLimit': '55.90', 'ciUpperLimit': '78.72', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.58', 'ciLowerLimit': '89.81', 'ciUpperLimit': '126.47', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '86.86', 'ciLowerLimit': '83.15', 'ciUpperLimit': '90.74', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '92.30', 'ciLowerLimit': '88.35', 'ciUpperLimit': '96.42', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.54', 'ciLowerLimit': '85.71', 'ciUpperLimit': '93.54', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Cmax of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'nanogram/millilitre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '180.4', 'spread': '48.87', 'groupId': 'OG000'}, {'value': '195.2', 'spread': '48.63', 'groupId': 'OG001'}, {'value': '200.1', 'spread': '54.89', 'groupId': 'OG002'}, {'value': '138.4', 'spread': '64.06', 'groupId': 'OG003'}, {'value': '187.8', 'spread': '40.22', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4486', 'spread': '37.86', 'groupId': 'OG000'}, {'value': '4332', 'spread': '46.40', 'groupId': 'OG001'}, {'value': '3551', 'spread': '37.17', 'groupId': 'OG002'}, {'value': '4114', 'spread': '35.79', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}, {'title': 'Oxypurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '170100', 'spread': '19.07', 'groupId': 'OG000'}, {'value': '167900', 'spread': '24.10', 'groupId': 'OG001'}, {'value': '153200', 'spread': '24.22', 'groupId': 'OG002'}, {'value': '153300', 'spread': '22.74', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.49', 'ciLowerLimit': '89.12', 'ciUpperLimit': '117.86', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '144.61', 'ciLowerLimit': '125.75', 'ciUpperLimit': '166.31', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '76.72', 'ciLowerLimit': '66.71', 'ciUpperLimit': '88.23', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.19', 'ciLowerLimit': '83.64', 'ciUpperLimit': '110.62', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.41', 'ciLowerLimit': '83.86', 'ciUpperLimit': '95.34', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.16', 'ciLowerLimit': '88.31', 'ciUpperLimit': '100.40', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.70', 'ciLowerLimit': '86.37', 'ciUpperLimit': '97.36', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.23', 'ciLowerLimit': '88.01', 'ciUpperLimit': '94.56', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.95', 'ciLowerLimit': '96.43', 'ciUpperLimit': '103.61', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90.13', 'ciLowerLimit': '86.95', 'ciUpperLimit': '93.42', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUCinf of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'hour*nanogram/millilitre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '169.3', 'spread': '47.82', 'groupId': 'OG000'}, {'value': '185.0', 'spread': '49.64', 'groupId': 'OG001'}, {'value': '190.3', 'spread': '55.76', 'groupId': 'OG002'}, {'value': '129.9', 'spread': '65.65', 'groupId': 'OG003'}, {'value': '176.4', 'spread': '39.80', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '4407', 'spread': '37.98', 'groupId': 'OG000'}, {'value': '4251', 'spread': '46.91', 'groupId': 'OG001'}, {'value': '3512', 'spread': '45.13', 'groupId': 'OG002'}, {'value': '4030', 'spread': '35.80', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '157100', 'spread': '16.84', 'groupId': 'OG000'}, {'value': '153100', 'spread': '21.35', 'groupId': 'OG001'}, {'value': '139200', 'spread': '21.05', 'groupId': 'OG002'}, {'value': '140100', 'spread': '19.57', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'analyses': [{'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '102.91', 'ciLowerLimit': '89.04', 'ciUpperLimit': '118.93', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '146.57', 'ciLowerLimit': '126.82', 'ciUpperLimit': '169.40', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '76.72', 'ciLowerLimit': '66.38', 'ciUpperLimit': '88.67', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG004'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.37', 'ciLowerLimit': '82.52', 'ciUpperLimit': '110.23', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '82.60', 'ciLowerLimit': '77.38', 'ciUpperLimit': '88.17', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '87.14', 'ciLowerLimit': '81.63', 'ciUpperLimit': '93.01', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '91.45', 'ciLowerLimit': '85.67', 'ciUpperLimit': '97.61', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '90.91', 'ciLowerLimit': '87.98', 'ciUpperLimit': '93.94', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.37', 'ciLowerLimit': '96.17', 'ciUpperLimit': '102.68', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG003'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '89.18', 'ciLowerLimit': '86.30', 'ciUpperLimit': '92.15', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUClast of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'hour*nanogram/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'Tmax: Time to Reach Maximum Observed Plasma Concentration Following Drug Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '5.00', 'groupId': 'OG000', 'lowerLimit': '3.00', 'upperLimit': '6.02'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.00', 'upperLimit': '5.08'}, {'value': '9.98', 'groupId': 'OG002', 'lowerLimit': '3.00', 'upperLimit': '12.03'}, {'value': '5.03', 'groupId': 'OG003', 'lowerLimit': '4.00', 'upperLimit': '10.02'}, {'value': '4.00', 'groupId': 'OG004', 'lowerLimit': '2.00', 'upperLimit': '6.00'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '1.50', 'groupId': 'OG000', 'lowerLimit': '0.50', 'upperLimit': '3.02'}, {'value': '1.50', 'groupId': 'OG001', 'lowerLimit': '0.50', 'upperLimit': '4.02'}, {'value': '3.00', 'groupId': 'OG002', 'lowerLimit': '0.50', 'upperLimit': '10.00'}, {'value': '1.50', 'groupId': 'OG003', 'lowerLimit': '0.50', 'upperLimit': '5.00'}, {'value': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '4.00', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '4.00', 'groupId': 'OG001', 'lowerLimit': '2.12', 'upperLimit': '8.02'}, {'value': '6.02', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '12.03'}, {'value': '4.00', 'groupId': 'OG003', 'lowerLimit': '0.52', 'upperLimit': '10.02'}, {'value': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The tmax of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'Tlag: Time Delay Between Drug Administration and First Observed Concentration in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '1.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '2.02'}, {'value': '1.02', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '2.00'}, {'value': '0.00', 'groupId': 'OG004', 'lowerLimit': '0.00', 'upperLimit': '0.50'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.50'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '1.02', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '4.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '1.02'}, {'value': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG001', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': '0.00', 'groupId': 'OG002', 'lowerLimit': '0.00', 'upperLimit': '1.00'}, {'value': '0.00', 'groupId': 'OG003', 'lowerLimit': '0.00', 'upperLimit': '0.00'}, {'value': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The tlag of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 't½λz: Half-life Associated With Terminal Slope (λz) of Semi-logarithmic Concentration-time Curve', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15.57', 'spread': '53.19', 'groupId': 'OG000'}, {'value': '14.17', 'spread': '58.62', 'groupId': 'OG001'}, {'value': '13.69', 'spread': '57.74', 'groupId': 'OG002'}, {'value': '13.77', 'spread': '61.38', 'groupId': 'OG003'}, {'value': '14.71', 'spread': '61.15', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1.164', 'spread': '21.78', 'groupId': 'OG000'}, {'value': '1.142', 'spread': '19.13', 'groupId': 'OG001'}, {'value': '1.696', 'spread': '56.37', 'groupId': 'OG002'}, {'value': '1.085', 'spread': '24.91', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}, {'title': 'Oxypurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19.06', 'spread': '19.81', 'groupId': 'OG000'}, {'value': '20.45', 'spread': '22.87', 'groupId': 'OG001'}, {'value': '20.14', 'spread': '23.18', 'groupId': 'OG002'}, {'value': '20.21', 'spread': '23.00', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The t½λz of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'λz: Terminal Elimination Rate Constant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.04437', 'spread': '55.10', 'groupId': 'OG000'}, {'value': '0.04876', 'spread': '65.26', 'groupId': 'OG001'}, {'value': '0.04957', 'spread': '61.83', 'groupId': 'OG002'}, {'value': '0.05063', 'spread': '57.34', 'groupId': 'OG003'}, {'value': '0.04651', 'spread': '60.92', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.5951', 'spread': '21.96', 'groupId': 'OG000'}, {'value': '0.6065', 'spread': '18.98', 'groupId': 'OG001'}, {'value': '0.4075', 'spread': '57.03', 'groupId': 'OG002'}, {'value': '0.6384', 'spread': '25.11', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}, {'title': 'Oxypurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.03653', 'spread': '19.58', 'groupId': 'OG000'}, {'value': '0.03309', 'spread': '24.22', 'groupId': 'OG001'}, {'value': '0.03512', 'spread': '23.12', 'groupId': 'OG002'}, {'value': '0.03425', 'spread': '24.67', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The λz of verinurad, allopurinol and oxypurinol were assessed as PK parameters', 'unitOfMeasure': 'per hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'CL/F: Apparent Total Body Clearance of Drug Clearance of Drug From Plasma After Extravascular Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '66.54', 'spread': '48.87', 'groupId': 'OG000'}, {'value': '61.46', 'spread': '48.63', 'groupId': 'OG001'}, {'value': '59.97', 'spread': '54.90', 'groupId': 'OG002'}, {'value': '86.73', 'spread': '64.06', 'groupId': 'OG003'}, {'value': '63.90', 'spread': '40.22', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '66.88', 'spread': '37.85', 'groupId': 'OG000'}, {'value': '69.25', 'spread': '46.40', 'groupId': 'OG001'}, {'value': '84.47', 'spread': '37.17', 'groupId': 'OG002'}, {'value': '72.93', 'spread': '35.78', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The CL/F of verinurad and allopurinol were assessed as PK parameters', 'unitOfMeasure': 'Liter/hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'MRTinf: Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18.99', 'spread': '41.94', 'groupId': 'OG000'}, {'value': '15.28', 'spread': '43.14', 'groupId': 'OG001'}, {'value': '18.91', 'spread': '40.50', 'groupId': 'OG002'}, {'value': '18.19', 'spread': '38.37', 'groupId': 'OG003'}, {'value': '15.94', 'spread': '52.27', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2.629', 'spread': '18.88', 'groupId': 'OG000'}, {'value': '2.950', 'spread': '23.30', 'groupId': 'OG001'}, {'value': '4.626', 'spread': '43.33', 'groupId': 'OG002'}, {'value': '2.827', 'spread': '37.87', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The MRTinf of verinurad and allopurinol were assessed as PK parameters', 'unitOfMeasure': 'hour', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'Vz/F: Apparent Volume of Distribution During Terminal Phase After Extravascular Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1495', 'spread': '62.63', 'groupId': 'OG000'}, {'value': '1256', 'spread': '69.76', 'groupId': 'OG001'}, {'value': '1184', 'spread': '74.23', 'groupId': 'OG002'}, {'value': '1723', 'spread': '89.59', 'groupId': 'OG003'}, {'value': '1356', 'spread': '55.95', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '112.4', 'spread': '31.38', 'groupId': 'OG000'}, {'value': '114.2', 'spread': '42.56', 'groupId': 'OG001'}, {'value': '206.7', 'spread': '80.39', 'groupId': 'OG002'}, {'value': '114.1', 'spread': '31.60', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Vz/F of verinurad and allopurinol were assessed as PK parameters', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'Vss/F: Apparent Volume of Distribution at Steady State Following Extravascular Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1264', 'spread': '55.42', 'groupId': 'OG000'}, {'value': '939.3', 'spread': '62.63', 'groupId': 'OG001'}, {'value': '1134', 'spread': '65.96', 'groupId': 'OG002'}, {'value': '1578', 'spread': '76.33', 'groupId': 'OG003'}, {'value': '1018', 'spread': '50.97', 'groupId': 'OG004'}]}]}, {'title': 'Allopurinol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '175.8', 'spread': '37.01', 'groupId': 'OG000'}, {'value': '204.3', 'spread': '38.33', 'groupId': 'OG001'}, {'value': '390.7', 'spread': '65.33', 'groupId': 'OG002'}, {'value': '206.1', 'spread': '45.73', 'groupId': 'OG003'}, {'value': 'NA', 'spread': 'NA', 'comment': 'As, subjects received only verinurad, hence this is not applicable', 'groupId': 'OG004'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Vss/F of verinurad and allopurinol were assessed as PK parameters', 'unitOfMeasure': 'Liter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'Emax, CB: Maximum Percentage Change From Baseline (CB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-50.44', 'spread': '8.304', 'groupId': 'OG000'}, {'value': '-53.84', 'spread': '9.947', 'groupId': 'OG001'}, {'value': '-56.63', 'spread': '9.618', 'groupId': 'OG002'}, {'value': '-54.43', 'spread': '8.895', 'groupId': 'OG003'}, {'value': '-38.15', 'spread': '9.724', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Emax, CB in serum uric acid (sUA) concentration (time-matched, Day -1) was assessed as PD parameter.', 'unitOfMeasure': 'percentage (%)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set consisted of all subjects in the safety analysis set who received at least one of the verinurad and allopurinol (or verinurad alone for Treatment 5) doses and who had at least one quantifiable time-matched sUA concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'tEmax, CB: Time of Maximum Percentage CB Change From Baseline (CB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '8.00', 'groupId': 'OG000', 'lowerLimit': '6.00', 'upperLimit': '48.00'}, {'value': '6.00', 'groupId': 'OG001', 'lowerLimit': '6.00', 'upperLimit': '48.00'}, {'value': '12.00', 'groupId': 'OG002', 'lowerLimit': '6.00', 'upperLimit': '48.00'}, {'value': '12.00', 'groupId': 'OG003', 'lowerLimit': '8.00', 'upperLimit': '12.00'}, {'value': '12.00', 'groupId': 'OG004', 'lowerLimit': '4.00', 'upperLimit': '48.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day -1, Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The tEmax, CB in serum uric acid (sUA) concentration (time-matched, Day -1) was assessed as PD parameter.', 'unitOfMeasure': 'hour', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD analysis set consisted of all subjects in the safety analysis set who received at least one of the verinurad and allopurinol (or verinurad alone for Treatment 5) doses and who had at least one quantifiable time-matched sUA concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Adverse Events (AEs) and Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '25', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fed state on Day 1'}, {'id': 'OG003', 'title': 'Treatment 4', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1'}, {'id': 'OG004', 'title': 'Treatment 5', 'description': 'Subjects received verinurad prolonged release gelatin capsule in fasted state on Day 1'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Any SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any SAE with outcome of death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any AE leading to discontinuation of IP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Any possibly related AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Any possibly related SAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)', 'description': 'The safety of single doses of verinurad and allopurinol were assessed', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all subjects who received at least one dose of IMP and for whom any safety post-dose data were available.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'PRIMARY', 'title': 'AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity in Fasted Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '180.4', 'spread': '48.87', 'groupId': 'OG000'}, {'value': '195.2', 'spread': '48.63', 'groupId': 'OG001'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '4486', 'spread': '37.86', 'groupId': 'OG000'}, {'value': '4332', 'spread': '46.40', 'groupId': 'OG001'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '170100', 'spread': '19.07', 'groupId': 'OG000'}, {'value': '167900', 'spread': '24.10', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.25', 'ciLowerLimit': '94.13', 'ciUpperLimit': '124.49', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.57', 'ciLowerLimit': '90.96', 'ciUpperLimit': '102.53', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.75', 'ciLowerLimit': '95.27', 'ciUpperLimit': '102.36', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUCinf of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters', 'unitOfMeasure': 'hour*nanogram/millilitre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'PRIMARY', 'title': 'AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration in Fasted Condition', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '169.3', 'spread': '47.82', 'groupId': 'OG000'}, {'value': '185.0', 'spread': '49.64', 'groupId': 'OG001'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '4407', 'spread': '37.98', 'groupId': 'OG000'}, {'value': '4251', 'spread': '46.91', 'groupId': 'OG001'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '157100', 'spread': '16.84', 'groupId': 'OG000'}, {'value': '153100', 'spread': '21.35', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.27', 'ciLowerLimit': '94.55', 'ciUpperLimit': '126.29', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.47', 'ciLowerLimit': '90.38', 'ciUpperLimit': '102.97', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '97.48', 'ciLowerLimit': '94.34', 'ciUpperLimit': '100.73', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUClast of verinurad, allopurinol and oxypurinol were assessed in fasted condition as PK parameters', 'unitOfMeasure': 'hour*nanogram/milliliter', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}, {'type': 'PRIMARY', 'title': 'Cmax: Maximum Observed Plasma Drug Concentration in Fasted State', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Subjects received verinurad prolonged release HPMC capsule and allopurinol tablet as a free combination in fasted state on Day 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Subjects received verinurad/allopurinol FDC capsule in fasted state on Day 1'}], 'classes': [{'title': 'Verinurad', 'categories': [{'measurements': [{'value': '26.62', 'spread': '50.71', 'groupId': 'OG000'}, {'value': '34.95', 'spread': '61.87', 'groupId': 'OG001'}]}]}, {'title': 'Allopurinol', 'categories': [{'measurements': [{'value': '1526', 'spread': '37.98', 'groupId': 'OG000'}, {'value': '1471', 'spread': '42.92', 'groupId': 'OG001'}]}]}, {'title': 'Oxypurinol', 'categories': [{'measurements': [{'value': '6376', 'spread': '16.67', 'groupId': 'OG000'}, {'value': '6066', 'spread': '21.61', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '131.28', 'ciLowerLimit': '107.03', 'ciUpperLimit': '161.02', 'groupDescription': 'Statistical Comparison of Verinurad\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '96.39', 'ciLowerLimit': '81.23', 'ciUpperLimit': '114.39', 'groupDescription': 'Statistical Comparison of Allopurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}, {'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '95.15', 'ciLowerLimit': '91.08', 'ciUpperLimit': '99.40', 'groupDescription': 'Statistical Comparison of Oxypurinol\n\nAnalysis of variance (ANOVA) of log transformed PK parameter with treatment, sequence, period as fixed effects and subject nested within sequence as random effect', 'nonInferiorityType': 'OTHER'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Cmax of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters', 'unitOfMeasure': 'nanogram/millilitre', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK analysis set included all subjects in the safety analysis set who received a verinurad + allopurinol (or verinurad alone for Treatment 5) dose and who had at least one quantifiable post-dose plasma concentration.\n\nHere, number analysed in each row signifies the subjects with available data that were analysed for each drug for that outcome measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence 12345', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'FG001', 'title': 'Treatment Sequence 23451', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'FG002', 'title': 'Treatment Sequence 34512', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'FG003', 'title': 'Treatment Sequence 45123', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'FG004', 'title': 'Treatment Sequence 51234', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was conducted between 13 April 2021 to 15 July 2021.', 'preAssignmentDetails': 'Subjects who met all the inclusion and none of the exclusion criteria were randomized at single center. The screening period was from Day -28 to Day -3. Informed consent form (ICF) was signed prior to screening procedures. All the study assessments were performed as per the schedule of assessment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence 12345', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'BG001', 'title': 'Treatment Sequence 23451', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'BG002', 'title': 'Treatment Sequence 34512', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'BG003', 'title': 'Treatment Sequence 45123', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state; Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'BG004', 'title': 'Treatment Sequence 51234', 'description': 'Subjects received single-dose treatments of verinurad and allopurinol or verinurad alone on 5 occasions \\[Treatment 5: verinurad prolonged release gelatin capsule, fasted state; Treatment 1: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fasted state; Treatment 2: verinurad/allopurinol FDC capsule, fasted state; Treatment 3: verinurad/allopurinol FDC capsule, fed state; Treatment 4: verinurad prolonged release HPMC capsule and allopurinol tablet, as a free combination, fed state\\] on Day 1 separated by at least 5 days washout between IMP administration.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '31.4', 'spread': '7.4', 'groupId': 'BG000'}, {'value': '34.2', 'spread': '8.0', 'groupId': 'BG001'}, {'value': '26.0', 'spread': '5.0', 'groupId': 'BG002'}, {'value': '33.0', 'spread': '4.7', 'groupId': 'BG003'}, {'value': '38.4', 'spread': '10.6', 'groupId': 'BG004'}, {'value': '32.6', 'spread': '8.0', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '22', 'groupId': 'BG005'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The randomized set consisted of all subjects randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-02-22', 'size': 957200, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-06-28T08:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-28', 'studyFirstSubmitDate': '2020-09-09', 'resultsFirstSubmitDate': '2022-06-28', 'studyFirstSubmitQcDate': '2020-09-09', 'lastUpdatePostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-28', 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity in Fasted Condition', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUCinf of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters'}, {'measure': 'AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration in Fasted Condition', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUClast of verinurad, allopurinol and oxypurinol were assessed in fasted condition as PK parameters'}, {'measure': 'Cmax: Maximum Observed Plasma Drug Concentration in Fasted State', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Cmax of verinurad, allopurinol and oxypurinol were assessed in fasted state as PK parameters'}], 'secondaryOutcomes': [{'measure': 'Cmax: Maximum Observed Plasma Drug Concentration', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Cmax of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 'AUCinf: Area Under Plasma Concentration-time Curve From 0 to Infinity', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUCinf of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 'AUClast: Area Under Plasma Concentration-time Curve From Zero to the Last Quantifiable Concentration', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The AUClast of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 'Tmax: Time to Reach Maximum Observed Plasma Concentration Following Drug Administration', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The tmax of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 'Tlag: Time Delay Between Drug Administration and First Observed Concentration in Plasma', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The tlag of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 't½λz: Half-life Associated With Terminal Slope (λz) of Semi-logarithmic Concentration-time Curve', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The t½λz of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 'λz: Terminal Elimination Rate Constant', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The λz of verinurad, allopurinol and oxypurinol were assessed as PK parameters'}, {'measure': 'CL/F: Apparent Total Body Clearance of Drug Clearance of Drug From Plasma After Extravascular Administration', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The CL/F of verinurad and allopurinol were assessed as PK parameters'}, {'measure': 'MRTinf: Mean Residence Time of the Unchanged Drug in the Systemic Circulation From Zero to Infinity', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The MRTinf of verinurad and allopurinol were assessed as PK parameters'}, {'measure': 'Vz/F: Apparent Volume of Distribution During Terminal Phase After Extravascular Administration', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Vz/F of verinurad and allopurinol were assessed as PK parameters'}, {'measure': 'Vss/F: Apparent Volume of Distribution at Steady State Following Extravascular Administration', 'timeFrame': 'Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Vss/F of verinurad and allopurinol were assessed as PK parameters'}, {'measure': 'Emax, CB: Maximum Percentage Change From Baseline (CB)', 'timeFrame': 'Day -1, Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The Emax, CB in serum uric acid (sUA) concentration (time-matched, Day -1) was assessed as PD parameter.'}, {'measure': 'tEmax, CB: Time of Maximum Percentage CB Change From Baseline (CB)', 'timeFrame': 'Day -1, Day 1, Day 2, Day 3 and Day 4 of each Treatment Period', 'description': 'The tEmax, CB in serum uric acid (sUA) concentration (time-matched, Day -1) was assessed as PD parameter.'}, {'measure': 'Number of Subjects With Adverse Events (AEs) and Serious Adverse Events', 'timeFrame': 'From screening (Day -28 to -3) until follow-up visit (7 to 14 days post final dose) (approximately 52 to 59 days)', 'description': 'The safety of single doses of verinurad and allopurinol were assessed'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['3-period', 'Crossover', 'URAT1 inhibitor', 'Xanthine oxidase inhibitor'], 'conditions': ['Chronic Kidney Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5495C00014&attachmentIdentifier=5bd8c3ee-4ea2-4d8c-833e-9e108efe7d44&fileName=D5495C00014_CSR_Synopsis_Redacted.pdf&versionIdentifier=', 'label': 'D5495C00014 CSR Synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D5495C00014&attachmentIdentifier=505ef90d-887e-4b32-8472-68345ad56b7a&fileName=D5495C00014_Final_Protocol_Redacted.pdf&versionIdentifier=', 'label': 'D5495C00014 Protocol'}]}, 'descriptionModule': {'briefSummary': 'This study is a single centre, randomised, open-label, single-dose, 5-period, 5-treatment, crossover study in healthy male and female subjects. This study is intended to assess the relative bioavailability between the fixed dose combination (FDC, i.e. verinurad/allopurinol FDC capsule 12/300 mg) and free combination formulations of verinurad (i.e. verinurad prolonged release Hydroxypropyl methylcellulose \\[HPMC\\] capsule 12 mg) and allopurinol (i.e. allopurinol table 300 mg) in fasted and fed conditions. The study will also assess the relative bioavailability between a formulation only containing verinurad (i.e. verinurad prolonged release gelatin capsule 12 mg) and the FDC capsule.', 'detailedDescription': 'The study comprises of:\n\n* A Screening Period of maximum 28 days;\n* Five treatment periods during which subjects will be resident from the morning of Day -2 until at least 72 hours after dosing in Treatment Period 5; discharged on the morning of Day 4 of Treatment Period 5; and\n* A Follow-up Visit 7 to 14 days after the last dosing.\n\nEach subject will receive 5 single dose treatments of verinurad and allopurinol or verinurad alone and subject will be involved in the study for 52 to 59 days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated, written informed consent prior to any study specific procedures.\n* Healthy male and female subjects aged 18 to 50 years (inclusive) with suitable veins for cannulation or repeated venepuncture.\n* Have a body mass index between 18 and 30 kg/m\\^2 (inclusive) and weigh at least 50 kg and no more than 100 kg (inclusive).\n* Females must have a negative pregnancy test at screening and on admission to the unit and must be:\n\n 1. not pregnant or currently lactating or breastfeeding.\n 2. of non-childbearing potential, confirmed at screening by fulfilling one of the following criteria: (i) postmenopausal defined as amenorrhea for at least 12 months or more following cessation of all exogenous hormonal treatments and follicle stimulating hormone (FSH) levels in the postmenopausal range (FSH levels \\> 40 IU/mL).\n\n (ii) documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.\n 3. OR if of childbearing potential must be willing to use an acceptable method of contraception to avoid pregnancy for the entire study period.\n* Must be able to swallow multiple capsules and tablets.\n\nExclusion Criteria:\n\n* History of gout or any clinically significant disease which, in the opinion of the principal investigator (PI), may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study.\n* Any clinically important illness, medical/surgical procedure or trauma within 4 weeks of the first administration of verinurad.\n* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any clinically important abnormalities in clinical chemistry, haematology or urinalysis results as judged by the Investigator at screening and first admission, including:\n\n 1. Alanine aminotransferase \\> 1.5 x upper limit of normal (ULN),\n 2. Aspartate aminotransferase \\> 1.5 x ULN,\n 3. Bilirubin (total) \\> 1.5 x ULN,\n 4. Gamma glutamyl transpeptidase \\> 1.5 x ULN.\n* Any clinically significant abnormal findings in vital signs at the Screening Visit and/or admission to the Clinical Unit, including, but not limited to, any of the following:\n\n 1. Pulse (resting, supine) \\< 50 beats per minute (bpm) or \\> 90 bpm,\n 2. Systolic blood pressure (BP) \\< 90 mmHg or \\> 140 mmHg and/or diastolic BP \\< 50 mmHg or \\> 90 mmHg sustained for \\> 10 minutes while resting in a supine position.\n* Any clinically significant abnormalities on 12 lead electrocardiogram (ECG) at the Screening Visit, including, but not limited to any of the following:\n\n 1. QTcF \\> 450 ms or \\< 340 ms or family history of long QT syndrome,\n 2. Any significant arrhythmia\n 3. Conduction abnormalities\n 4. Clinically significant PR (PQ) interval prolongation (\\> 240 ms); intermittent second or third degree AV block, or AV dissociation\n 5. Complete bundle branch block and/or QRS duration \\> 120 ms.\n* Any positive result at the Screening Visit for serum Hepatitis B surface antigen or Anti Hepatitis B core antibody, hepatitis virus C antibody, and human immunodeficiency virus antibody.\n* Suspicion or known Gilbert's and/or Lesch Nyhan syndrome.\n* Known or suspected history of alcohol or drug abuse or excessive intake of alcohol as judged by the PI.\n* Has received another new chemical or biological entity within 30 days or at least 5 half lives of the first administration of verinurad in this study.\n* Subjects who have previously received verinurad.\n* Plasma donation within 1 month of screening or any blood donation/loss of more than 500 mL during the 3 months prior to the Screening Visit.\n* Subjects who are pregnant, lactating or planning to become pregnant.\n* Hypersensitivity to verinurad, allopurinol or any drug with a similar chemical structure/class to verinurad and/or allopurinol.\n* Current smokers or those who have smoked or used nicotine products (including e cigarettes) within the 3 months prior to screening.\n* Excessive intake of caffeine containing drinks or food as judged by the PI.\n* Positive screen for drugs of abuse or cotinine (nicotine) at the Screening Visit or positive screen for alcohol, drugs of abuse and cotinine on each admission to the study centre.\n* Use of drugs with enzyme inducing properties within 3 weeks prior to the first administration of verinurad.\n* Use of any prescribed or non prescribed medication including antacids, analgesics, herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of verinurad or longer if the medication has a long half life.\n* Any AstraZeneca, Parexel or study site employee or their close relatives.\n* Subjects who cannot communicate reliably with the PI and/or is not able to read, speak and understand the German language.\n* Judgment by the PI that the subject should not participate in the study if they have any ongoing or recent (i.e., during the screening period) minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.\n* Vulnerable subjects, e.g., kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.\n* Subjects with any special dietary restrictions such as subjects that are lactose intolerant or are vegetarians/vegans.\n* Subject is a carrier of the HLA B\\*58:01 allele.\n* Subject has a positive test result for severe acute respiratory syndrome corona virus (SARS-CoV-2) RT-PCR before randomisation.\n* Subject has clinical signs and symptoms consistent with Coronavirus disease 2019 (COVID-19), eg, fever, dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate laboratory test within the last 4 weeks prior to screening or on admission.\n* History of severe COVID-19 (hospitalisation, extracorporeal membrane oxygenation, mechanically ventilated).\n* Subjects who are regularly exposed to COVID-19 as part of their daily life.\n* Subjects who have had or are planning to have the COVID-19 vaccination within 4 weeks prior to screening or at any time during the study."}, 'identificationModule': {'nctId': 'NCT04550234', 'briefTitle': 'A Study in Healthy Subjects to Assess Drug Availability of 4 Different Formulations of Verinurad and Allopurinol', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomised, Single Dose, 5-period, 5-treatment, Crossover Study to Assess the Relative Bioavailability of 4 Different Formulations of Verinurad and Allopurinol in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D5495C00014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'description': 'Subjects will receive verinurad prolonged release HPMC capsule and allopurinol tablet in fasted state on Day 1.', 'interventionNames': ['Drug: Verinurad prolonged release HPMC capsule', 'Drug: Allopurinol Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 2', 'description': 'Subjects will receive verinurad/allopurinol FDC capsule in fasted state on Day 1.', 'interventionNames': ['Drug: Verinurad/Allopurinol FDC Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 3', 'description': 'Subjects will receive verinurad/allopurinol FDC capsule in fed state on Day 1.', 'interventionNames': ['Drug: Verinurad/Allopurinol FDC Capsule']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 4', 'description': 'Subjects will receive verinurad prolonged release HPMC capsule and allopurinol tablet in fed state on Day 1.', 'interventionNames': ['Drug: Verinurad prolonged release HPMC capsule', 'Drug: Allopurinol Tablet']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 5', 'description': 'Subjects will receive verinurad prolonged release gelatin capsule in fasted state on Day 1.', 'interventionNames': ['Drug: Verinurad prolonged release gelatin Capsule']}], 'interventions': [{'name': 'Verinurad prolonged release HPMC capsule', 'type': 'DRUG', 'description': 'Randomized subjects will receive oral dose of verinurad HPMC capsule.', 'armGroupLabels': ['Treatment 1', 'Treatment 4']}, {'name': 'Allopurinol Tablet', 'type': 'DRUG', 'description': 'Randomized subjects will receive oral dose of allopurinol tablet.', 'armGroupLabels': ['Treatment 1', 'Treatment 4']}, {'name': 'Verinurad/Allopurinol FDC Capsule', 'type': 'DRUG', 'description': 'Randomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule.', 'armGroupLabels': ['Treatment 2', 'Treatment 3']}, {'name': 'Verinurad prolonged release gelatin Capsule', 'type': 'DRUG', 'description': 'Randomized subjects will receive oral dose of Verinurad gelatin capsule.', 'armGroupLabels': ['Treatment 5']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Research Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the requests portal. All request will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}