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The purpose of this study is to determine the relative bioavailability of RDEA3170 capsules compared with RDEA3170 tablets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment A | Experimental | RDEA3170, 5 mg (FN24), administered in the fasted state. |
|
| Treatment B | Experimental | RDEA3170, 5 mg (FN24), administered in the fed state (high-fat, high-calorie meal). |
|
| Treatment C | Experimental | RDEA3170, 10 mg (FN25), administered in the fasted state. |
|
| Treatment D | Experimental | RDEA3170, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal). |
|
| Treatment E | Experimental | RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. |
|
| Treatment I | Experimental | RDEA3170, 10 mg (FN26), administered in the fasted state. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDEA3170,10 mg | Drug | Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed concentration of a drug after administration | Day 1, 5, 9, 13, 17 |
| Time of Occurrence of Maximum Observed Concentration (Tmax) | Tmax is the time of occurrence of cmax | Day 1, 5, 9, 13, 17 |
| 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 | Day 1, 5, 9, 13, 17 |
| Area Under the Concentration-time Curve From 0 to Infinity (AUC∞) | AUC 0-∞ is a meausre of total concentration from time zero to infinity | Day 1, 5, 9, 13, 17 |
| Apparent Terminal Half-life (t1/2) | t1/2 is a measure of apparent terminal half-life | Day 1, 5, 9, 13, 17 |
| 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 | Day 1, 5, 9, 13, 17 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| J Hall, MD | Ardea Biosciences, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Austin | Texas | 78744 | United States |
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.
35 participants were randomized
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Sequence ABECD (Days 1, 5, 9, 13, and 17) | 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 |
| FG001 | Cohort 1: Sequence AEBDC (Days 1, 5, 9, 13, and 17) | 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 |
| FG002 | Cohort 1: Sequence EADBC (Days 1, 5, 9, 13, and 17) | 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 |
| FG003 | Cohort 1: Sequence EDACB (Days 1, 5, 9, 13, and 17) | 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 |
| FG004 | Cohort 1: Sequence DECAB (Days 1, 5, 9, 13, and 17) | 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 |
| FG005 | Cohort 1: Sequence BACED (Days 1, 5, 9, 13, and 17) | 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 |
| FG006 | Cohort 1: Sequence BCADE (Days 1, 5, 9, 13, and 17) | 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 |
| FG007 | Cohort 1: Sequence CBDAE (Days 1, 5, 9, 13, and 17) | 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 |
| FG008 | Cohort 1: Sequence CDBEA (Days 1, 5, 9, 13, and 17) | 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 |
| FG009 | Cohort 1: Sequence DCEBA (Days 1, 5, 9, 13, and 17) | 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 |
| FG010 | Cohort 3: Sequence IJK (Days 1, 5, and 9) | 10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted |
| FG011 | Cohort 3: Sequence JKI (Days 1, 5, and 9) | 10 mg FN26 capsules, fed; 10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted |
| FG012 | Cohort 3: Sequence KIJ (Days 1, 5, and 9) | 10 mg FN17 tablets, fasted; 10 mg FN26 capsules, fasted; 10 mg FN26 capsules, fed |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maximum Observed Plasma Concentration (Cmax) | Cmax is the maximum observed concentration of a drug after administration | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 1, 5, 9, 13, 17 |
|
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Overall number of baseline participants used to determine number of participants at risk.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment A | Verinurad capsules, 5 mg (FN24), administered in the fasted state. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Viral Infection | Infections and infestations | MedDRA 15.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jesse Hall, MD | Ardea Biosciences, Inc. | (858) 652-6672 | JHall@ardeabio.com |
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| ID | Term |
|---|---|
| C000628929 | verinurad |
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|
| Treatment J | Experimental | RDEA3170, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal). |
|
| Treatment K | Experimental | RDEA3170, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. |
|
|
| RDEA3170, 2.5 mg | Drug | Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. |
|
|
| RDEA3170, 5 mg | Drug | Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17. |
|
|
| RDEA3170, 10 mg | Drug | Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9. |
|
|
| RDEA3170, 2.5 mg | Drug | Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9. |
|
|
| Day 1, 5, 9, 13, 17 |
| 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 | Day 1, 5, 9, 13, 17 |
| Day -1, 1, 5, 9, 13, 17 |
| Incidence of Treatment-Emergent Adverse Events | 8 weeks |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex/Gender, Customized | Number | Participants |
|
| Region of Enrollment | Number | Participants |
|
| OG002 | Treatment E | RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. |
| OG003 | Treatment I | RDEA3170 capsules, 10 mg (FN26), administered in the fasted state. |
| OG004 | Treatment K | RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state |
|
|
|
| Primary | Time of Occurrence of Maximum Observed Concentration (Tmax) | Tmax is the time of occurrence of cmax | 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. | Posted | Median | Full Range | hr | Day 1, 5, 9, 13, 17 |
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng·hr/mL | Day 1, 5, 9, 13, 17 |
|
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng·hr/mL | Day 1, 5, 9, 13, 17 |
|
|
|
|
| Primary | Apparent Terminal Half-life (t1/2) | t1/2 is a measure of apparent terminal half-life | 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. | Posted | Geometric Mean | 95% Confidence Interval | hr | Day 1, 5, 9, 13, 17 |
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng/mL | Day 1, 5, 9, 13, 17 |
|
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng·hr/mL | Day 1, 5, 9, 13, 17 |
|
|
|
|
| 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 | 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. | Posted | Geometric Mean | 95% Confidence Interval | ng·hr/mL | Day 1, 5, 9, 13, 17 |
|
|
|
|
| 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. | 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. | Posted | Mean | Standard Error | Percent (%) Change | Day -1, 1, 5, 9, 13, 17 |
|
|
|
| Secondary | Incidence of Treatment-Emergent Adverse Events | The safety population included all participants who received any dose of investigational product. | Posted | Number | Number of participants | 8 weeks |
|
|
|
| 0 |
| 20 |
| 1 |
| 20 |
| EG001 | Treatment B | Verinurad capsules, 5 mg (FN24), administered in the fed state (highfat, high-calorie meal). | 0 | 20 | 1 | 20 |
| EG002 | Treatment C | Verinurad capsules, 10 mg (FN25), administered in the fasted state. | 0 | 20 | 0 | 20 |
| EG003 | Treatment D | RDEA3170 capsules, 10 mg (FN25), administered in the fed state (high-fat, high-calorie meal) | 0 | 20 | 0 | 20 |
| EG004 | Treatment E | RDEA3170 tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. | 0 | 20 | 0 | 20 |
| EG005 | Treatment I | Verinurad capsules, 10 mg (FN26), administered in the fasted state. | 0 | 15 | 2 | 15 |
| EG006 | Treatment J | Verinurad capsules, 10 mg (FN26), administered in the fed state (high-fat, high-calorie meal). | 0 | 15 | 2 | 15 |
| EG007 | Treatment K | Verinurad tablets, 2.5 mg (FN17), administered as 10 mg (4 × 2.5 mg), in the fasted state. | 0 | 15 | 0 | 15 |
| Headache | Nervous system disorders | MedDRA 15.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.1 | Systematic Assessment |
|
| Musculoskeletal Stiffness | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Systematic Assessment |
|
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.
|
| Mixed Models Analysis |
A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. |
| Geometric Least Squares mean Ratio |
| 170 |
| 2-Sided |
| 90 |
| 146 |
| 199 |
| Non-Inferiority or Equivalence |
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. |
| Mixed Models Analysis | A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. | Geometric Least Squares mean Ratio | 129 | 2-Sided | 90 | 114 | 146 | Non-Inferiority or Equivalence | 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. |
|
| Mixed Models Analysis |
A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. |
| Geometric Least Squares mean Ratio |
| 159 |
| 2-Sided |
| 90 |
| 135 |
| 188 |
| Non-Inferiority or Equivalence |
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. |
| Mixed Models Analysis | A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. | Geometric Least Squares mean Ratio | 131 | 2-Sided | 90 | 116 | 147 | Non-Inferiority or Equivalence | 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. |
|
| Mixed Models Analysis |
A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. |
| Geometric Least Squares mean Ratio |
| 99.9 |
| 2-Sided |
| 90 |
| 85.5 |
| 117 |
| Non-Inferiority or Equivalence |
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. |
| Mixed Models Analysis | A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. | Geometric Least Squares mean Ratio | 116 | 2-Sided | 90 | 94.8 | 143 | Non-Inferiority or Equivalence | 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. |
|
| Mixed Models Analysis |
A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. |
| Geometric Least Squares mean Ratio |
| 104 |
| 2-Sided |
| 90 |
| 95.0 |
| 113 |
| Non-Inferiority or Equivalence |
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. |
| Mixed Models Analysis | A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. | Geometric Least Squares mean Ratio | 115 | 2-Sided | 90 | 95.3 | 140 | Non-Inferiority or Equivalence | 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 |
|
| Mixed Models Analysis |
A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. |
| Geometric Least Squares mean Ratio |
| 103 |
| 2-Sided |
| 90 |
| 94.6 |
| 113 |
| Non-Inferiority or Equivalence |
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 |
| Mixed Models Analysis | A mixed effect model on the natural log-transformed PK parameters Cmax, AUClast, and AUC∞ with fixed effect for treatment. | Geometric Least Squares mean Ratio | 113 | 2-Sided | 90 | 93.3 | 137 | Non-Inferiority or Equivalence | 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 |
| Urine Uric Acid % Change (0-24h) |
|
| Renal Clearance of Uric Acid % Change (0-24h) |
|
| Fractional Excretion of uric acid % Change (0-24h) |
|