Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2026-01-21 @ 1:26 PM
Study NCT ID:
NCT02448368
Status:
COMPLETED
Last Update Posted:
2018-08-20
First Post:
2015-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RDEA3170 Tablet and Capsule Bioavailability Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000628929', 'term': 'verinurad'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'JHall@ardeabio.com', 'phone': '(858) 652-6672', 'title': 'Jesse Hall, MD', 'organization': 'Ardea Biosciences, Inc.'}, 'certainAgreement': {'otherDetails': "PI shall submit a copy of the Publication to Sponsor for review at least 45 days prior to its proposed submission. Sponsor reserves the right to delay any such publication for an additional period of 60 days. Upon Sponsor's request, PI agrees to delete from the proposed publication any Confidential Information. PI agrees not to release any publication without the prior written permission of Sponsor.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'Overall number of baseline participants used to determine number of participants at risk.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Treatment D', 'description': 'RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.', 'otherNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Treatment I', 'description': 'Verinurad capsules, 10 mg (FN26), administered in the fasted state.', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Treatment J', 'description': 'Verinurad capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).', 'otherNumAtRisk': 15, 'otherNumAffected': 2, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Treatment K', 'description': 'Verinurad tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.', 'otherNumAtRisk': 15, 'otherNumAffected': 0, 'seriousNumAtRisk': 15, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Viral Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Musculoskeletal Stiffness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 15, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 15, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG002', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG004', 'title': 'Treatment K', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '17.8'}, {'value': '23.4', 'groupId': 'OG001', 'lowerLimit': '19.3', 'upperLimit': '28.2'}, {'value': '12.9', 'groupId': 'OG002', 'lowerLimit': '11.2', 'upperLimit': '14.9'}, {'value': '14.0', 'groupId': 'OG003', 'lowerLimit': '12.1', 'upperLimit': '16.3'}, {'value': '13.2', 'groupId': 'OG004', 'lowerLimit': '11.2', 'upperLimit': '15.5'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least Squares Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '232', 'ciLowerLimit': '202', 'ciUpperLimit': '266', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the Pharmacokinetics (PK), Pharmacodynamics (PD), and safety profile of RDEA3170.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '181', 'ciLowerLimit': '164', 'ciUpperLimit': '200', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106', 'ciLowerLimit': '91.5', 'ciUpperLimit': '124', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'Cmax is the maximum observed concentration of a drug after administration', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.'}, {'type': 'PRIMARY', 'title': 'Time of Occurrence of Maximum Observed Concentration (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'RDEA3170 capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)'}, {'id': 'OG004', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'OG005', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG006', 'title': 'Treatment J', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).'}, {'id': 'OG007', 'title': 'Treatment K', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.00', 'spread': '2.05', 'groupId': 'OG000', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '4.00', 'spread': '1.69', 'groupId': 'OG001', 'lowerLimit': '3.00', 'upperLimit': '10.0'}, {'value': '3.50', 'spread': '1.74', 'groupId': 'OG002', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '4.00', 'spread': '1.05', 'groupId': 'OG003', 'lowerLimit': '3.00', 'upperLimit': '8.00'}, {'value': '2.00', 'spread': '1.54', 'groupId': 'OG004', 'lowerLimit': '1.00', 'upperLimit': '4.00'}, {'value': '2.00', 'spread': '2.71', 'groupId': 'OG005', 'lowerLimit': '1.00', 'upperLimit': '6.00'}, {'value': '6.00', 'spread': '2.45', 'groupId': 'OG006', 'lowerLimit': '3.00', 'upperLimit': '12.0'}, {'value': '3.00', 'spread': '2.66', 'groupId': 'OG007', 'lowerLimit': '1.00', 'upperLimit': '6.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'Tmax is the time of occurrence of cmax', 'unitOfMeasure': 'hr', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG002', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG004', 'title': 'Treatment K', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000', 'lowerLimit': '80.6', 'upperLimit': '103'}, {'value': '185', 'groupId': 'OG001', 'lowerLimit': '163', 'upperLimit': '211'}, {'value': '109', 'groupId': 'OG002', 'lowerLimit': '89.9', 'upperLimit': '132'}, {'value': '149', 'groupId': 'OG003', 'lowerLimit': '130', 'upperLimit': '171'}, {'value': '115', 'groupId': 'OG004', 'lowerLimit': '96.9', 'upperLimit': '137'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '170', 'ciLowerLimit': '147', 'ciUpperLimit': '195', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '170', 'ciLowerLimit': '146', 'ciUpperLimit': '199', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '129', 'ciLowerLimit': '114', 'ciUpperLimit': '146', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG002', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG004', 'title': 'Treatment K', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '95.7', 'groupId': 'OG000', 'lowerLimit': '84.5', 'upperLimit': '108'}, {'value': '192', 'groupId': 'OG001', 'lowerLimit': '169', 'upperLimit': '219'}, {'value': '121', 'groupId': 'OG002', 'lowerLimit': '97.0', 'upperLimit': '150'}, {'value': '161', 'groupId': 'OG003', 'lowerLimit': '140', 'upperLimit': '184'}, {'value': '123', 'groupId': 'OG004', 'lowerLimit': '103', 'upperLimit': '146'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '161', 'ciLowerLimit': '139', 'ciUpperLimit': '187', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '159', 'ciLowerLimit': '135', 'ciUpperLimit': '188', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG003', 'OG004'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '131', 'ciLowerLimit': '116', 'ciUpperLimit': '147', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'AUC 0-∞ is a meausre of total concentration from time zero to infinity', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.'}, {'type': 'PRIMARY', 'title': 'Apparent Terminal Half-life (t1/2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'RDEA3170 capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)'}, {'id': 'OG004', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'OG005', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG006', 'title': 'Treatment J', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).'}, {'id': 'OG007', 'title': 'Treatment K', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'spread': '2.05', 'groupId': 'OG000', 'lowerLimit': '11.2', 'upperLimit': '16.5'}, {'value': '14.9', 'spread': '1.69', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '17.6'}, {'value': '14.0', 'spread': '1.74', 'groupId': 'OG002', 'lowerLimit': '11.5', 'upperLimit': '17.0'}, {'value': '12.9', 'spread': '1.05', 'groupId': 'OG003', 'lowerLimit': '10.6', 'upperLimit': '15.6'}, {'value': '17.3', 'spread': '1.54', 'groupId': 'OG004', 'lowerLimit': '13.4', 'upperLimit': '22.3'}, {'value': '14.4', 'spread': '2.71', 'groupId': 'OG005', 'lowerLimit': '9.70', 'upperLimit': '21.5'}, {'value': '15.8', 'spread': '2.45', 'groupId': 'OG006', 'lowerLimit': '11.6', 'upperLimit': '21.5'}, {'value': '13.2', 'spread': '2.66', 'groupId': 'OG007', 'lowerLimit': '9.44', 'upperLimit': '18.6'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 't1/2 is a measure of apparent terminal half-life', 'unitOfMeasure': 'hr', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.'}, {'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'RDEA3170 capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)'}, {'id': 'OG004', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG005', 'title': 'Treatment J', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).'}], 'classes': [{'categories': [{'measurements': [{'value': '14.9', 'groupId': 'OG000', 'lowerLimit': '12.5', 'upperLimit': '17.8'}, {'value': '15.0', 'groupId': 'OG001', 'lowerLimit': '12.6', 'upperLimit': '18.0'}, {'value': '23.4', 'groupId': 'OG002', 'lowerLimit': '19.3', 'upperLimit': '28.2'}, {'value': '23.3', 'groupId': 'OG003', 'lowerLimit': '19.2', 'upperLimit': '28.3'}, {'value': '14.0', 'groupId': 'OG004', 'lowerLimit': '12.1', 'upperLimit': '16.3'}, {'value': '16.3', 'groupId': 'OG005', 'lowerLimit': '12.9', 'upperLimit': '20.7'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.4', 'ciLowerLimit': '88.3', 'ciUpperLimit': '112', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG002', 'OG003'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.9', 'ciLowerLimit': '85.5', 'ciUpperLimit': '117', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}, {'groupIds': ['OG004', 'OG005'], 'paramType': 'Geometric Least Squares mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '116', 'ciLowerLimit': '94.8', 'ciUpperLimit': '143', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': 'A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment.', 'nonInferiorityComment': 'The sample size is not based on formal power calculations, as this study is designed only to provide an initial assessment of the PK, PD, and safety profile of RDEA3170.'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'Cmax is the maximum observed concentration of a drug after administration', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. 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'spread': '10.0', 'groupId': 'OG007', 'lowerLimit': '32.4', 'upperLimit': '75.3'}]}]}, {'title': 'Renal Clearance of Uric Acid % Change (0-24h)', 'categories': [{'measurements': [{'value': '137', 'spread': '33.1', 'groupId': 'OG000', 'lowerLimit': '10.9', 'upperLimit': '14.6'}, {'value': '175', 'spread': '27.2', 'groupId': 'OG001', 'lowerLimit': '13.9', 'upperLimit': '17.2'}, {'value': '226', 'spread': '48.4', 'groupId': 'OG002', 'lowerLimit': '15.3', 'upperLimit': '20.1'}, {'value': '216', 'spread': '23.7', 'groupId': 'OG003', 'lowerLimit': '15.1', 'upperLimit': '20.9'}, {'value': '142', 'spread': '27.1', 'groupId': 'OG004', 'lowerLimit': '11.7', 'upperLimit': '15.3'}, {'value': '117', 'spread': '17.4', 'groupId': 'OG005', 'lowerLimit': '12.0', 'upperLimit': '16.5'}, {'value': '153', 'spread': '17.2', 'groupId': 'OG006', 'lowerLimit': '14.4', 'upperLimit': '19.8'}, {'value': '107', 'spread': '17.7', 'groupId': 'OG007', 'lowerLimit': '11.6', 'upperLimit': '15.4'}]}]}, {'title': 'Fractional Excretion of uric acid % Change (0-24h)', 'categories': [{'measurements': [{'value': '119', 'spread': '13.1', 'groupId': 'OG000', 'lowerLimit': '9.82', 'upperLimit': '13.3'}, {'value': '157', 'spread': '12.9', 'groupId': 'OG001', 'lowerLimit': '12.0', 'upperLimit': '15.5'}, {'value': '214', 'spread': '14.5', 'groupId': 'OG002', 'lowerLimit': '15.0', 'upperLimit': '18.8'}, {'value': '214', 'spread': '14.3', 'groupId': 'OG003', 'lowerLimit': '15.0', 'upperLimit': '18.6'}, {'value': '145', 'spread': '15.1', 'groupId': 'OG004', 'lowerLimit': '11.1', 'upperLimit': '14.7'}, {'value': '137', 'spread': '18.4', 'groupId': 'OG005', 'lowerLimit': '11.2', 'upperLimit': '15.3'}, {'value': '168', 'spread': '15.5', 'groupId': 'OG006', 'lowerLimit': '13.5', 'upperLimit': '17.6'}, {'value': '120', 'spread': '14.2', 'groupId': 'OG007', 'lowerLimit': '10.5', 'upperLimit': '14.3'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1, 1, 5, 9, 13, 17', 'description': 'Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.', 'unitOfMeasure': 'Percent (%) Change', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'A subject in Treatment A was excluded from pharmacokinetic (PK) analysis on Day 13 (but not from pharmacodynamics analysis) following oral administration of 5 mg (FN24) capsules under the fasted condition due to a suspected dosing error. There was no evaluable PK available on Day 13 for this subject.'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}, {'value': '15', 'groupId': 'OG005'}, {'value': '15', 'groupId': 'OG006'}, {'value': '15', 'groupId': 'OG007'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Verinurad capsules, 5 mg (FN24), administered in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'RDEA3170 capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal).'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Verinurad capsules, 10 mg (FN25), administered in the fasted state.'}, {'id': 'OG003', 'title': 'Treatment D', 'description': 'RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal)'}, {'id': 'OG004', 'title': 'Treatment E', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'OG005', 'title': 'Treatment I', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fasted state.'}, {'id': 'OG006', 'title': 'Treatment J', 'description': 'RDEA3170 capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).'}, {'id': 'OG007', 'title': 'Treatmnet K', 'description': 'RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '2', 'groupId': 'OG006'}, {'value': '0', 'groupId': 'OG007'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '8 weeks', 'unitOfMeasure': 'Number of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population included all participants who received any dose of investigational product.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1: Sequence ABECD (Days 1, 5, 9, 13, and 17)', 'description': '5 mg FN24 capsules, fasted; 5 mg FN24 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fasted; 10 mg FN25 capsules, fed'}, {'id': 'FG001', 'title': 'Cohort 1: Sequence AEBDC (Days 1, 5, 9, 13, and 17)', 'description': '5 mg FN24 capsules, fasted; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fed; 10 mg FN25 capsules, fasted'}, {'id': 'FG002', 'title': 'Cohort 1: Sequence EADBC (Days 1, 5, 9, 13, and 17)', 'description': '10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fasted'}, {'id': 'FG003', 'title': 'Cohort 1: Sequence EDACB (Days 1, 5, 9, 13, and 17)', 'description': '10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fed'}, {'id': 'FG004', 'title': 'Cohort 1: Sequence DECAB (Days 1, 5, 9, 13, and 17)', 'description': '10 mg FN25 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fasted; 5 mg FN24 capsules, fed'}, {'id': 'FG005', 'title': 'Cohort 1: Sequence BACED (Days 1, 5, 9, 13, and 17)', 'description': '5 mg FN24 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fasted; 10 mg FN17 tablets, fasted; 10 mg FN25 capsules, fed'}, {'id': 'FG006', 'title': 'Cohort 1: Sequence BCADE (Days 1, 5, 9, 13, and 17)', 'description': '5 mg FN24 capsules, fed; 10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fasted; 10 mg FN25 capsules, fed; 10 mg FN17 tablets, fasted'}, {'id': 'FG007', 'title': 'Cohort 1: Sequence CBDAE (Days 1, 5, 9, 13, and 17)', 'description': '10 mg FN25 capsules, fasted; 5 mg FN24 capsules, fed; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fasted; 10 mg FN17 tablets, fasted'}, {'id': 'FG008', 'title': 'Cohort 1: Sequence CDBEA (Days 1, 5, 9, 13, and 17)', 'description': '10 mg FN25 capsules, fasted; 10 mg FN25 capsules, fed; 5 mg FN24 capsules, fed; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fasted'}, {'id': 'FG009', 'title': 'Cohort 1: Sequence DCEBA (Days 1, 5, 9, 13, and 17)', 'description': '10 mg FN25 capsules, fed; 10 mg FN25 capsules, fasted; 10 mg FN17 tablets, fasted; 5 mg FN24 capsules, fed; 5 mg FN24 capsules, fasted'}, {'id': 'FG010', 'title': 'Cohort 3: Sequence IJK (Days 1, 5, and 9)', 'description': '10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted'}, {'id': 'FG011', 'title': 'Cohort 3: Sequence JKI (Days 1, 5, and 9)', 'description': '10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted'}, {'id': 'FG012', 'title': 'Cohort 3: Sequence KIJ (Days 1, 5, and 9)', 'description': '10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '5'}, {'groupId': 'FG011', 'numSubjects': '5'}, {'groupId': 'FG012', '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'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}, {'groupId': 'FG012', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '35 participants were randomized', 'preAssignmentDetails': 'Twenty subjects were randomized to 1 of 10 treatment sequences in Cohort 1 with single doses. Fifteen subjects were randomized to 1 of 3 treatment sequences (IJK, JKI, and KIJ) in optional Cohort 3, with single doses occurring on Days 1, 5, and 9. The optional Cohort 2 to evaluate RDEA3170 capsules, 5 mg FN23 was not conducted per Sponsor decision.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'Treatment A: RDEA3170 capsules, 5 mg (FN24), administered in the fasted state. Treatment B: RDEA3170 capsules, 5 mg FN24, administered in the fed state (high-fat, high-calorie meal). Treatment C: RDEA3170 capsules, 10 mg (FN25), administered in the fasted state. Treatment D: RDEA3170 capsules, 10 mg FN25, administered in the fed state (high-fat, high-calorie meal). Treatment E: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state.'}, {'id': 'BG001', 'title': 'Cohort 3 (Optional)', 'description': 'Treatment I: RDEA3170 capsules, 10 mg (FN26), administered in the fasted state. Treatment J: RDEA3170 capsules, 10 mg FN26, administered in the fed state (high-fat, high-calorie meal).\n\nTreatment K: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '35', 'spread': '8.9', 'groupId': 'BG000'}, {'value': '41', 'spread': '12.0', 'groupId': 'BG001'}, {'value': '38', 'spread': '10.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-01-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-17', 'studyFirstSubmitDate': '2015-04-30', 'resultsFirstSubmitDate': '2017-06-12', 'studyFirstSubmitQcDate': '2015-05-15', 'lastUpdatePostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-11-17', 'studyFirstPostDateStruct': {'date': '2015-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-06-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'Cmax is the maximum observed concentration of a drug after administration'}, {'measure': 'Time of Occurrence of Maximum Observed Concentration (Tmax)', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'Tmax is the time of occurrence of cmax'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint'}, {'measure': 'Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'AUC 0-∞ is a meausre of total concentration from time zero to infinity'}, {'measure': 'Apparent Terminal Half-life (t1/2)', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 't1/2 is a measure of apparent terminal half-life'}, {'measure': 'Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'Cmax is the maximum observed concentration of a drug after administration'}, {'measure': 'AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint'}, {'measure': 'AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules', 'timeFrame': 'Day 1, 5, 9, 13, 17', 'description': 'AUC 0-∞ is a meausre of total concentration from time zero to infinity'}], 'secondaryOutcomes': [{'measure': 'Pharmacodynamics (PD) Profile of RDEA3170', 'timeFrame': 'Day -1, 1, 5, 9, 13, 17', 'description': 'Serum samples were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours prior to dosing. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose. Urine samples (total catch) were collected at the following timepoints in relation to RDEA3170 dosing: Day 1 (Cohort 1 and Cohort 3): -24 to -21, -21 to -18, -18 to -12, and -12 to 0 hours predose. Days 1, 5, and 9 (Cohort 1 and Cohort 3), and Days 13 and 17 (Cohort 1 only): 0 to 3, 3 to 6, 6 to 12, and 12 to 24 hours postdose.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able to understand the study procedures and the risks involved, and is willing to provide written informed consent before the first study-related activity.\n* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.\n* Subject has a Screening serum urate level of 4 to 7 mg/dL.\n* Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.\n\nExclusion Criteria:\n\n* Subject has a history or suspicion of kidney stones.\n* Subject has undergone major surgery within 3 months prior to Screening.\n* Subject donated blood or experienced significant blood loss within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1.\n* Subject has clinically unacceptable physical examination, per the Investigator's judgment.\n* Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment.\n* Subject has Screening clinical safety laboratory parameters (serum chemistry \\[other than serum creatinine and serum urate\\], hematology, coagulation or urinalysis) that are outside the normal limits and are considered clinically significant by the Investigator.\n* Subject has a serum creatinine value above the upper limit of normal at the Screening visit.\n* Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment.\n* Subject has a history of cardiac abnormalities\n* Subject cannot swallow multiple tablets or capsules.\n* Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1."}, 'identificationModule': {'nctId': 'NCT02448368', 'briefTitle': 'RDEA3170 Tablet and Capsule Bioavailability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardea Biosciences, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Open-Label, Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability and Food Effect of Various Formulations of RDEA3170', 'orgStudyIdInfo': {'id': 'RDEA3170-111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment A', 'description': 'RDEA3170, 5 mg (FN24), administered in the fasted state.', 'interventionNames': ['Drug: RDEA3170, 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment B', 'description': 'RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal).', 'interventionNames': ['Drug: RDEA3170, 5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment C', 'description': 'RDEA3170, 10 mg (FN25), administered in the fasted state.', 'interventionNames': ['Drug: RDEA3170,10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment D', 'description': 'RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal).', 'interventionNames': ['Drug: RDEA3170,10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment E', 'description': 'RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.', 'interventionNames': ['Drug: RDEA3170, 2.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment I', 'description': 'RDEA3170, 10 mg (FN26), administered in the fasted state.', 'interventionNames': ['Drug: RDEA3170, 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment J', 'description': 'RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal).', 'interventionNames': ['Drug: RDEA3170, 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment K', 'description': 'RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state.', 'interventionNames': ['Drug: RDEA3170, 2.5 mg']}], 'interventions': [{'name': 'RDEA3170,10 mg', 'type': 'DRUG', 'otherNames': ['Cohort 1'], 'description': 'Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.', 'armGroupLabels': ['Treatment C', 'Treatment D']}, {'name': 'RDEA3170, 2.5 mg', 'type': 'DRUG', 'otherNames': ['Cohort 1'], 'description': 'Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.', 'armGroupLabels': ['Treatment E']}, {'name': 'RDEA3170, 5 mg', 'type': 'DRUG', 'otherNames': ['Cohort 1'], 'description': 'Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.', 'armGroupLabels': ['Treatment A', 'Treatment B']}, {'name': 'RDEA3170, 10 mg', 'type': 'DRUG', 'otherNames': ['Cohort 3'], 'description': 'Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.', 'armGroupLabels': ['Treatment I', 'Treatment J']}, {'name': 'RDEA3170, 2.5 mg', 'type': 'DRUG', 'otherNames': ['Cohort 3'], 'description': 'Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.', 'armGroupLabels': ['Treatment K']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78744', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'J Hall, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ardea Biosciences, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ardea Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}