Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2026-03-17 @ 3:53 AM
Study NCT ID:
NCT02336594
Status:
COMPLETED
Last Update Posted:
2017-10-13
First Post:
2014-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RDEA3170 Bioavailability Study
Sponsor:
Organization:
Raw JSON
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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. 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administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).'}], 'classes': [{'categories': [{'measurements': [{'value': '130', 'groupId': 'OG000', 'lowerLimit': '95.9', 'upperLimit': '176'}, {'value': '108', 'groupId': 'OG001', 'lowerLimit': '84.4', 'upperLimit': '139'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Geometric Least Squares mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '83.4', 'ciLowerLimit': '73.5', 'ciUpperLimit': '94.7', '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': 'Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC∞ of RDEA3170 in low-fat fed state.', 'unitOfMeasure': 'ng·hr/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': '10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': '10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': '10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).'}, {'id': 'OG003', 'title': 'Treatment D', 'description': '10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).'}], 'classes': [{'title': 'Serum Urate Maximum % Change', 'categories': [{'measurements': [{'value': '-34.4', 'spread': '2.08', 'groupId': 'OG000'}, {'value': '-34.4', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '-37.3', 'spread': '1.89', 'groupId': 'OG002'}, {'value': '-49.0', 'spread': '1.96', 'groupId': 'OG003'}]}]}, {'title': 'Urine Uric Acid % Change(0-24h)', 'categories': [{'measurements': [{'value': '96.6', 'spread': '12.5', 'groupId': 'OG000'}, {'value': '78.5', 'spread': '8.38', 'groupId': 'OG001'}, {'value': '53.4', 'spread': '8.85', 'groupId': 'OG002'}, {'value': '65.9', 'spread': '9.70', 'groupId': 'OG003'}]}]}, {'title': 'Renal Clearance of Uric Acid % Change (0-24h)', 'categories': [{'measurements': [{'value': '170', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '147', 'spread': '15.6', 'groupId': 'OG001'}, {'value': '128', 'spread': '18.9', 'groupId': 'OG002'}, {'value': '179', 'spread': '21.5', 'groupId': 'OG003'}]}]}, {'title': 'Fractional Excretion of Uric Acid % Change (0-24h)', 'categories': [{'measurements': [{'value': '159', 'spread': '15.1', 'groupId': 'OG000'}, {'value': '151', 'spread': '22.0', 'groupId': 'OG001'}, {'value': '149', 'spread': '22.7', 'groupId': 'OG002'}, {'value': '199', 'spread': '23.2', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.', 'description': 'PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.', 'unitOfMeasure': 'Percent', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Incidence of Treatment-Emergent Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': '10 mg dose of RDEA3170, administered as 4 × 2.5 mg tablets, in the fasted state.'}, {'id': 'OG001', 'title': 'Treatment B', 'description': '10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fasted state.'}, {'id': 'OG002', 'title': 'Treatment C', 'description': '10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (low-fat, high calorie meal).'}, {'id': 'OG003', 'title': 'Treatment D', 'description': '10 mg dose of RDEA3170, administered as a single 10 mg tablet, in the fed state (high-fat, high calorie meal).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 weeks.', 'unitOfMeasure': 'Number of Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Sequence ABCD', 'description': 'Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).'}, {'id': 'FG001', 'title': 'Sequence BACD', 'description': 'Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal); Day 13 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal).'}, {'id': 'FG002', 'title': 'Sequence ABDC', 'description': 'Day 1 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 5 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).'}, {'id': 'FG003', 'title': 'Sequence BADC', 'description': 'Day 1 (Treatment B): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fasted state; Day 5 (Treatment A): 10 mg dose of RDEA3170, administered as 4 × 2.5 mg ER tablets, in the fasted state; Day 9 (Treatment D): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (high-fat, high-calorie meal); Day 13 (Treatment C): 10 mg dose of RDEA3170, administered as a single 10 mg ER tablet, in the fed state (low-fat, high-calorie meal).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '15 subjects were randomized', 'preAssignmentDetails': 'Fifteen subjects were randomized to 1 of 4 treatment sequences (ABCD, BACD, ABDC, BADC) in a 1:1:1:1 ratio.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Sequence ABCD', 'description': '2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.'}, {'id': 'BG001', 'title': 'Sequence BACD', 'description': '10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat'}, {'id': 'BG002', 'title': 'Sequence ABDC', 'description': '2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat'}, {'id': 'BG003', 'title': 'Sequence BADC', 'description': '10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '51', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '39', 'spread': '9.7', 'groupId': 'BG001'}, {'value': '40', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '42', 'spread': '16.0', 'groupId': 'BG003'}, {'value': '42', 'spread': '11.9', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '<65', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}, {'title': '>=65', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}]}], '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': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-09', 'studyFirstSubmitDate': '2014-11-06', 'resultsFirstSubmitDate': '2017-05-15', 'studyFirstSubmitQcDate': '2015-01-09', 'lastUpdatePostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-10-09', 'studyFirstPostDateStruct': {'date': '2015-01-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-10-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'Cmax of RDEA3170 in fasted condition.'}, {'measure': 'Time of Occurrence of Maximum Observed Concentration (Tmax)', 'timeFrame': 'Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'Tmax of RDEA3170 following various treatments.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)', 'timeFrame': 'Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC last of RDEA3170 in fasted condition.'}, {'measure': 'Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)', 'timeFrame': 'Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC∞ of RDEA3170 the fasted condition.'}, {'measure': 'Apparent Terminal Half-life (t1/2)', 'timeFrame': 'Days 1 and 5 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 't1/2 of RDEA3170 following various treatments.'}, {'measure': 'Cmax: Effect of High Fat Meal on the PK of RDEA3170 Tablets', 'timeFrame': 'Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'Cmax of RDEA3170 in high-fat fed state.'}, {'measure': 'AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Tablets', 'timeFrame': 'Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC last of RDEA3170 in high-fat fed state.'}, {'measure': 'AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Tablets', 'timeFrame': 'Days 1 to 13 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC∞ of RDEA3170 in high-fat fed state.'}, {'measure': 'Cmax: Effect of Low Fat Meal on the PK of RDEA3170 Tablets', 'timeFrame': 'Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'Cmax of RDEA3170 in low-fat fed state.'}, {'measure': 'AUC Last: Effect of Low Fat Meal on the PK of RDEA3170 Tablets', 'timeFrame': 'Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC last of RDEA3170 in low-fat fed state.'}, {'measure': 'AUC∞: Effect of Low Fat Meal on the PK of RDEA3170 Tablets', 'timeFrame': 'Days 1 to 9 at predose, 30 minutes postdose, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose.', 'description': 'AUC∞ of RDEA3170 in low-fat fed state.'}], 'secondaryOutcomes': [{'measure': 'Single Dose Pharmacodynamics (PD) Profile of RDEA3170 From Serum and Urine', 'timeFrame': 'Day -1: -24, -23, -22, -21, -20, -18, -16, -14, and -12 hours predose. Days 1, 5, 9, and 13: predose (within 30 minutes prior to dosing) and 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours postdose.', 'description': 'PD profiles of uric acid from serum and urine. PD parameters were evaluated to assess whether any potential differences in PK for the 2 different tablets resulted in differences in uric acid excretion.'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events', 'timeFrame': '7 weeks.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Gout']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1, randomized, open-label, 4-way crossover pharmacokinetic (PK) and pharmacodynamic (PD) study in healthy adult male subjects designed to assess the relative bioavailability of RDEA3170 2.5 mg tablets administered as a 10 mg dose (2.5 mg × 4 tablets) and of a single RDEA3170 10 mg tablet. This study will also assess the effect of a low-fat and high-fat meal on the PK and PD of RDEA3170 10 mg 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 ≤ 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 (\\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to Day 1\n* Subject has inadequate venous access or unsuitable veins for repeated venipuncture\n* Subject has a Screening serum creatinine value above the upper limit of normal during Screening or at Day -2 (Admission)\n* Subject cannot swallow multiple tablets\n* Subject is a heavy caffeine drinker\n* Subject is unwilling to comply with the dietary restrictions of the study\n* Subject is unable or unwilling to comply with the study requirements or has a situation or condition that, in the opinion of the Investigator, may interfere with participation in the study"}, 'identificationModule': {'nctId': 'NCT02336594', 'briefTitle': 'RDEA3170 Bioavailability Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ardea Biosciences, Inc.'}, 'officialTitle': 'A Phase 1, Randomized, Open-Label, Crossover Study in Healthy Adult Male Subjects to Assess the Relative Bioavailability of Two RDEA3170 Tablets', 'orgStudyIdInfo': {'id': 'RDEA3170-110'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Sequence ABCD', 'description': '2.5 mg x 4 tablets qd (once daily) fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat.', 'interventionNames': ['Drug: RDEA3170 10 mg', 'Drug: RDEA3170 2.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BACD', 'description': '10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed low-fat, 10 mg tablet qd fed high-fat', 'interventionNames': ['Drug: RDEA3170 10 mg', 'Drug: RDEA3170 2.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence ABDC', 'description': '2.5 x 4 mg tablets qd fasted, 10 mg tablet qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat', 'interventionNames': ['Drug: RDEA3170 10 mg', 'Drug: RDEA3170 2.5 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Sequence BADC', 'description': '10 mg tablet qd fasted, 2.5 mg x 4 tablets qd fasted, 10 mg tablet qd fed high-fat, 10 mg tablet qd fed low-fat', 'interventionNames': ['Drug: RDEA3170 10 mg', 'Drug: RDEA3170 2.5 mg']}], 'interventions': [{'name': 'RDEA3170 10 mg', 'type': 'DRUG', 'armGroupLabels': ['Sequence ABCD', 'Sequence ABDC', 'Sequence BACD', 'Sequence BADC']}, {'name': 'RDEA3170 2.5 mg', 'type': 'DRUG', 'armGroupLabels': ['Sequence ABCD', 'Sequence ABDC', 'Sequence BACD', 'Sequence BADC']}]}, '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'}}}}