Healthy
Conditions
Brief summary
The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
Interventions
DRUGRDEA3170,10 mg
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
DRUGRDEA3170, 2.5 mg
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
DRUGRDEA3170, 5 mg
Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
DRUGRDEA3170, 10 mg
Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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. * Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. * Subject has a Screening serum urate level of 4 to 7 mg/dL. * Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.
Exclusion criteria
* Subject has a history or suspicion of kidney stones. * Subject has undergone major surgery within 3 months prior to Screening. * 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. * Subject has clinically unacceptable physical examination, per the Investigator's judgment. * Subject has clinically relevant abnormalities in blood pressure, heart rate, or body temperature, per the Investigator's judgment. * 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. * Subject has a serum creatinine value above the upper limit of normal at the Screening visit. * Subject has clinically relevant abnormalities in 12-lead electrocardiogram, per the Investigator's judgment. * Subject has a history of cardiac abnormalities * Subject cannot swallow multiple tablets or capsules. * Subject has received any strong or moderate enzyme-inducing drug or product within 2 months prior to Day 1.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | Day 1, 5, 9, 13, 17 | AUC 0-∞ is a meausre of total concentration from time zero to infinity |
| Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | Day 1, 5, 9, 13, 17 | Cmax is the maximum observed concentration of a drug after administration |
| AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | Day 1, 5, 9, 13, 17 | AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint |
| Maximum Observed Plasma Concentration (Cmax) | Day 1, 5, 9, 13, 17 | Cmax is the maximum observed concentration of a drug after administration |
| Time of Occurrence of Maximum Observed Concentration (Tmax) | Day 1, 5, 9, 13, 17 | Tmax is the time of occurrence of cmax |
| Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | Day 1, 5, 9, 13, 17 | AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint |
| Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | Day 1, 5, 9, 13, 17 | AUC 0-∞ is a meausre of total concentration from time zero to infinity |
| Apparent Terminal Half-life (t1/2) | Day 1, 5, 9, 13, 17 | t1/2 is a measure of apparent terminal half-life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events | 8 weeks | — |
| Pharmacodynamics (PD) Profile of RDEA3170 | Day -1, 1, 5, 9, 13, 17 | 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. |
Countries
United States
Participant flow
Recruitment details
35 participants were randomized
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 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. | 20 |
| Cohort 3 (Optional) 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).
Treatment K: RDEA3170 tablets, 2.5 mg FN17, administered as 10 mg (4 × 2.5 mg), in the fasted state | 15 |
| Total | 35 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 3 (Optional) | Total |
|---|---|---|---|
| Age, Continuous | 35 Years STANDARD_DEVIATION 8.9 | 41 Years STANDARD_DEVIATION 12 | 38 Years STANDARD_DEVIATION 10.45 |
| Region of Enrollment United States | 20 Participants | 15 Participants | 35 Participants |
| Sex/Gender, Customized Female | 0 Participants | 0 Participants | 0 Participants |
| Sex/Gender, Customized Male | 20 Participants | 15 Participants | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk | EG007 affected / at risk |
|---|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 1 / 20 | 1 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 2 / 15 | 2 / 15 | 0 / 15 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 15 | 0 / 15 | 0 / 15 |
Outcome results
Primary
Apparent Terminal Half-life (t1/2)
t1/2 is a measure of apparent terminal half-life
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Treatment A | Apparent Terminal Half-life (t1/2) | 13.6 hr | 95% Confidence Interval 2.05 |
| Treatment C | Apparent Terminal Half-life (t1/2) | 14.9 hr | 95% Confidence Interval 1.69 |
| Treatment E | Apparent Terminal Half-life (t1/2) | 14.0 hr | 95% Confidence Interval 1.74 |
| Treatment I | Apparent Terminal Half-life (t1/2) | 12.9 hr | 95% Confidence Interval 1.05 |
| Treatment K | Apparent Terminal Half-life (t1/2) | 17.3 hr | 95% Confidence Interval 1.54 |
| Treatment I | Apparent Terminal Half-life (t1/2) | 14.4 hr | 95% Confidence Interval 2.71 |
| Treatment J | Apparent Terminal Half-life (t1/2) | 15.8 hr | 95% Confidence Interval 2.45 |
| Treatment K | Apparent Terminal Half-life (t1/2) | 13.2 hr | 95% Confidence Interval 2.66 |
Primary
Area Under the Concentration-time Curve From 0 to Infinity (AUC∞)
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | 95.7 ng·hr/mL |
| Treatment C | Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | 192 ng·hr/mL |
| Treatment E | Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | 121 ng·hr/mL |
| Treatment I | Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | 161 ng·hr/mL |
| Treatment K | Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | 123 ng·hr/mL |
90% CI: [139, 187]Mixed Models Analysis
90% CI: [135, 188]Mixed Models Analysis
90% CI: [116, 147]Mixed Models Analysis
Primary
Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last)
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | 91.2 ng·hr/mL |
| Treatment C | Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | 185 ng·hr/mL |
| Treatment E | Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | 109 ng·hr/mL |
| Treatment I | Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | 149 ng·hr/mL |
| Treatment K | Area Under the Concentration-time Curve From Time Zero to the Quantifiable Last Sampling Timepoint (AUC Last) | 115 ng·hr/mL |
90% CI: [147, 195]Mixed Models Analysis
90% CI: [146, 199]Mixed Models Analysis
90% CI: [114, 146]Mixed Models Analysis
Primary
AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules
AUC 0-∞ is a meausre of total concentration from time zero to infinity
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 95.7 ng·hr/mL |
| Treatment C | AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 104 ng·hr/mL |
| Treatment E | AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 192 ng·hr/mL |
| Treatment I | AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 199 ng·hr/mL |
| Treatment K | AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 161 ng·hr/mL |
| Treatment I | AUC∞: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 182 ng·hr/mL |
90% CI: [98.1, 116]Mixed Models Analysis
90% CI: [94.6, 113]Mixed Models Analysis
90% CI: [93.3, 137]Mixed Models Analysis
Primary
AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules
AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 91.2 ng·hr/mL |
| Treatment C | AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 99.2 ng·hr/mL |
| Treatment E | AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 185 ng·hr/mL |
| Treatment I | AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 192 ng·hr/mL |
| Treatment K | AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 149 ng·hr/mL |
| Treatment I | AUC Last: Effect of High Fat Meal on the PK of RDEA3170 Capsules | 172 ng·hr/mL |
90% CI: [95, 113]Mixed Models Analysis
90% CI: [95.3, 140]Mixed Models Analysis
90% CI: [98.3, 116]Mixed Models Analysis
Primary
Maximum Observed Plasma Concentration (Cmax)
Cmax is the maximum observed concentration of a drug after administration
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Maximum Observed Plasma Concentration (Cmax) | 14.9 ng/mL |
| Treatment C | Maximum Observed Plasma Concentration (Cmax) | 23.4 ng/mL |
| Treatment E | Maximum Observed Plasma Concentration (Cmax) | 12.9 ng/mL |
| Treatment I | Maximum Observed Plasma Concentration (Cmax) | 14.0 ng/mL |
| Treatment K | Maximum Observed Plasma Concentration (Cmax) | 13.2 ng/mL |
90% CI: [202, 266]Mixed Models Analysis
90% CI: [164, 200]Mixed Models Analysis
90% CI: [91.5, 124]Mixed Models Analysis
Primary
Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules
Cmax is the maximum observed concentration of a drug after administration
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Treatment A | Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | 14.9 ng/mL |
| Treatment C | Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | 15.0 ng/mL |
| Treatment E | Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | 23.4 ng/mL |
| Treatment I | Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | 23.3 ng/mL |
| Treatment K | Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | 14.0 ng/mL |
| Treatment I | Maximum Observed Plasma Concentration (Cmax): Effect of High Fat Meal on the PK of RDEA3170 Capsules | 16.3 ng/mL |
90% CI: [88.3, 112]Mixed Models Analysis
90% CI: [85.5, 117]Mixed Models Analysis
90% CI: [94.8, 143]Mixed Models Analysis
Primary
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax is the time of occurrence of cmax
Time frame: Day 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| Treatment A | Time of Occurrence of Maximum Observed Concentration (Tmax) | 3.00 hr | Full Range 2.05 |
| Treatment C | Time of Occurrence of Maximum Observed Concentration (Tmax) | 4.00 hr | Full Range 1.69 |
| Treatment E | Time of Occurrence of Maximum Observed Concentration (Tmax) | 3.50 hr | Full Range 1.74 |
| Treatment I | Time of Occurrence of Maximum Observed Concentration (Tmax) | 4.00 hr | Full Range 1.05 |
| Treatment K | Time of Occurrence of Maximum Observed Concentration (Tmax) | 2.00 hr | Full Range 1.54 |
| Treatment I | Time of Occurrence of Maximum Observed Concentration (Tmax) | 2.00 hr | Full Range 2.71 |
| Treatment J | Time of Occurrence of Maximum Observed Concentration (Tmax) | 6.00 hr | Full Range 2.45 |
| Treatment K | Time of Occurrence of Maximum Observed Concentration (Tmax) | 3.00 hr | Full Range 2.66 |
Secondary
Incidence of Treatment-Emergent Adverse Events
Time frame: 8 weeks
Population: The safety population included all participants who received any dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Treatment A | Incidence of Treatment-Emergent Adverse Events | 1 Number of participants |
| Treatment C | Incidence of Treatment-Emergent Adverse Events | 1 Number of participants |
| Treatment E | Incidence of Treatment-Emergent Adverse Events | 0 Number of participants |
| Treatment I | Incidence of Treatment-Emergent Adverse Events | 0 Number of participants |
| Treatment K | Incidence of Treatment-Emergent Adverse Events | 0 Number of participants |
| Treatment I | Incidence of Treatment-Emergent Adverse Events | 2 Number of participants |
| Treatment J | Incidence of Treatment-Emergent Adverse Events | 2 Number of participants |
| Treatment K | Incidence of Treatment-Emergent Adverse Events | 0 Number of participants |
Secondary
Pharmacodynamics (PD) Profile of RDEA3170
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.
Time frame: Day -1, 1, 5, 9, 13, 17
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Treatment A | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 137 Percent (%) Change | Standard Error 33.1 |
| Treatment A | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 79.2 Percent (%) Change | Standard Error 21.6 |
| Treatment A | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -29.1 Percent (%) Change | Standard Error 2.05 |
| Treatment A | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 119 Percent (%) Change | Standard Error 13.1 |
| Treatment C | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 92.3 Percent (%) Change | Standard Error 19 |
| Treatment C | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -40.6 Percent (%) Change | Standard Error 1.69 |
| Treatment C | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 175 Percent (%) Change | Standard Error 27.2 |
| Treatment C | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 157 Percent (%) Change | Standard Error 12.9 |
| Treatment E | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 109 Percent (%) Change | Standard Error 27.8 |
| Treatment E | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -42.5 Percent (%) Change | Standard Error 1.74 |
| Treatment E | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 214 Percent (%) Change | Standard Error 14.5 |
| Treatment E | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 226 Percent (%) Change | Standard Error 48.4 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -52.3 Percent (%) Change | Standard Error 1.05 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 214 Percent (%) Change | Standard Error 14.3 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 216 Percent (%) Change | Standard Error 23.7 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 88.8 Percent (%) Change | Standard Error 13.6 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 142 Percent (%) Change | Standard Error 27.1 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 145 Percent (%) Change | Standard Error 15.1 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -30.3 Percent (%) Change | Standard Error 1.54 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 76.8 Percent (%) Change | Standard Error 14.4 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -35.2 Percent (%) Change | Standard Error 2.71 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 137 Percent (%) Change | Standard Error 18.4 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 117 Percent (%) Change | Standard Error 17.4 |
| Treatment I | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 49.5 Percent (%) Change | Standard Error 8.22 |
| Treatment J | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -46.2 Percent (%) Change | Standard Error 2.45 |
| Treatment J | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 53.7 Percent (%) Change | Standard Error 8.56 |
| Treatment J | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 168 Percent (%) Change | Standard Error 15.5 |
| Treatment J | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 153 Percent (%) Change | Standard Error 17.2 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Fractional Excretion of uric acid % Change (0-24h) | 120 Percent (%) Change | Standard Error 14.2 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Renal Clearance of Uric Acid % Change (0-24h) | 107 Percent (%) Change | Standard Error 17.7 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Urine Uric Acid % Change (0-24h) | 53.9 Percent (%) Change | Standard Error 10 |
| Treatment K | Pharmacodynamics (PD) Profile of RDEA3170 | Serum Urate Maximum % Change | -29.3 Percent (%) Change | Standard Error 2.66 |