Gout
Conditions
Brief summary
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
Interventions
DRUGRDEA3170
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2. * Subject with renal impairment, as determined at Screening, with creatinine clearance as calculated by the Cockcroft-Gault formula of 60 to \< 90 mL/min (mild impairment), 30 to \< 60 mL/min (moderate impairment), or 15 to \< 30 mL/min (severe impairment), or a matched control subject (by age and body mass index) with a creatinine clearance of ≥ 90 mL/min. * Subject has a Screening serum urate level ≥ 4.5 mg/dL and ≤ 10 mg/dL
Exclusion criteria
* Subject has a history or clinical manifestations of significant metabolic, hematological, pulmonary, cardiovascular, gastrointestinal, neurologic, hepatic, renal, urological, or psychiatric disorders. * Subject has a history or suspicion of kidney stones. * Subject has a history of asthma. * Subject has undergone major surgery within 3 months prior to Day 1. * Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Total Body Clearance Corrected for Bioavailability (CL/F) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Maximum Observed Plasma Concentration (Cmax) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Time of Occurrence of Maximum Observed Concentration (Tmax) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function |
| Apparent Terminal Half-life (t1/2) | Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose | t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose) |
| Incidence of Treatment-Emergent Adverse Events | 5 weeks |
Countries
United States
Participant flow
Recruitment details
31 subjects were randomized
Pre-assignment details
Thirty-one subjects were randomized to 1 of 4 cohorts. Cohort 1: mild renal impairment; Cohort 2: moderate renal impairment; Cohort 3: severe renal impairment and Cohort 4: normal renal function. All 31 subjects received a single dose of 15 mg RDEA3170 (6 x 2.5 mg) in the fasted state.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg Mild Renal Impairment (eCrCl of 60 to \< 90 mL/min) + RDEA3170 15 mg once daily (qd) fasted | 8 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg Moderate Renal Impairment (eCrCl of 30 to \< 60 mL/min) + RDEA3170 15 mg qd fasted | 8 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg Severe Renal Impairment (eCrCl of 15 to \< 30 mL/min) + RDEA3170 15 mg qd fasted | 7 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg Control subjects With Normal Renal Function (eCrCl of ≥ 90 mL/min) + RDEA3170 15 mg qd fasted | 8 |
| Total | 31 |
Baseline characteristics
| Characteristic | Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Cohort 4: Normal Renal Function + RDEA3170 15 mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 63 Years STANDARD_DEVIATION 6.4 | 67 Years STANDARD_DEVIATION 14.9 | 58 Years STANDARD_DEVIATION 11.1 | 56 Years STANDARD_DEVIATION 4.7 | 61 Years STANDARD_DEVIATION 9.3 |
| Region of Enrollment United States | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 31 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 8 Participants | 8 Participants | 7 Participants | 8 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 8 | 1 / 8 | 2 / 7 | 1 / 8 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 7 | 0 / 8 |
Outcome results
Primary
Apparent Terminal Half-life (t1/2)
t1/2 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Apparent Terminal Half-life (t1/2) | 9.53 hr |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Apparent Terminal Half-life (t1/2) | 20.6 hr |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Apparent Terminal Half-life (t1/2) | 22.0 hr |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Apparent Terminal Half-life (t1/2) | 13.0 hr |
Primary
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
AUC last following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | 197 ng.hr/mL |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | 333 ng.hr/mL |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | 316 ng.hr/mL |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) | 150 ng.hr/mL |
90% CI: [98.6, 174]Fixed Effects Model
90% CI: [171, 287]Fixed Effects Model
90% CI: [139, 319]Fixed Effects Model
Primary
Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞)
AUC∞ following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) | 201 ng.hr/mL |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) | 402 ng.hr/mL |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) | 372 ng.hr/mL |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUC∞) | 162 ng.hr/mL |
90% CI: [88.8, 173]Fixed Effects Model
90% CI: [168, 366]Fixed Effects Model
90% CI: [146, 363]Fixed Effects Model
Primary
Maximum Observed Plasma Concentration (Cmax)
Cmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Maximum Observed Plasma Concentration (Cmax) | 25.6 ng/mL |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Maximum Observed Plasma Concentration (Cmax) | 29.0 ng/mL |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Maximum Observed Plasma Concentration (Cmax) | 38.2 ng/mL |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Maximum Observed Plasma Concentration (Cmax) | 16.7 ng/mL |
90% CI: [115, 203]Fixed Effects Model
90% CI: [131, 230]Fixed Effects Model
90% CI: [155, 336]Fixed Effects Model
Primary
Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72)
CLNR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) | 74.9 L/hr |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) | 44.5 L/hr |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) | 47.2 L/hr |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Non-renal Clearance From Time 0 to 72 Hours Postdose (CLNR 0-72) | 98.6 L/hr |
90% CI: [57.1, 101]Fixed Effects Model
90% CI: [34.9, 58.3]Fixed Effects Model
90% CI: [31.5, 72.5]Fixed Effects Model
Primary
Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72)
CLR 0-72 following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) | 12.9 mL/min |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) | 7.87 mL/min |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) | 2.86 mL/min |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Renal Clearance Time 0 to 72 Hours Postdose (CLR 0-72) | 13.5 mL/min |
90% CI: [60.6, 150]Fixed Effects Model
90% CI: [30.2, 113]Fixed Effects Model
90% CI: [13.6, 32.8]Fixed Effects Model
Primary
Time of Occurrence of Maximum Observed Concentration (Tmax)
Tmax following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Time of Occurrence of Maximum Observed Concentration (Tmax) | 2.50 hr |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Time of Occurrence of Maximum Observed Concentration (Tmax) | 3.00 hr |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Time of Occurrence of Maximum Observed Concentration (Tmax) | 2.00 hr |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Time of Occurrence of Maximum Observed Concentration (Tmax) | 2.50 hr |
Primary
Total Body Clearance Corrected for Bioavailability (CL/F)
CL/F following a single administration of RDEA3170 to subjects with various degrees of renal function
Time frame: Day 1: within 30 minutes prior to dosing and at 30 minutes, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 30, 36, 48, 54, 60, and 72 hours postdose
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Total Body Clearance Corrected for Bioavailability (CL/F) | 74.8 L/hr |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Total Body Clearance Corrected for Bioavailability (CL/F) | 37.3 L/hr |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Total Body Clearance Corrected for Bioavailability (CL/F) | 40.3 L/hr |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Total Body Clearance Corrected for Bioavailability (CL/F) | 92.6 L/hr |
90% CI: [57.9, 113]Fixed Effects Model
90% CI: [27.3, 59.5]Fixed Effects Model
90% CI: [27.5, 68.7]Fixed Effects Model
Secondary
Incidence of Treatment-Emergent Adverse Events
Time frame: 5 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Incidence of Treatment-Emergent Adverse Events | 3 Number of participants |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Incidence of Treatment-Emergent Adverse Events | 1 Number of participants |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Incidence of Treatment-Emergent Adverse Events | 2 Number of participants |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Incidence of Treatment-Emergent Adverse Events | 1 Number of participants |
Secondary
Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine
Time frame: Screening, Day -1 ( -24, -21, -18, -and -12 hours predose), and Day 1 (within 30 minutes prior to dosing and at 3, 6, 12, 24, 30, 36, 48, 54, 60, and 72 hours postdose)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Serum Urate Maximum % Change | -36.9 Maximum Percentage (%) Change | Standard Error 4.79 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (0-24h) | 118 Maximum Percentage (%) Change | Standard Error 25.3 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (0-24h) | 222 Maximum Percentage (%) Change | Standard Error 50.5 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (0-24h) | 206 Maximum Percentage (%) Change | Standard Error 44.9 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (24-48h) | -9.49 Maximum Percentage (%) Change | Standard Error 6.68 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (48-72h) | -23.1 Maximum Percentage (%) Change | Standard Error 7.63 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (24-48h) | 42.1 Maximum Percentage (%) Change | Standard Error 12.9 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (48-72h) | 2.39 Maximum Percentage (%) Change | Standard Error 6.84 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (24-48h) | 39.2 Maximum Percentage (%) Change | Standard Error 10.8 |
| Cohort 1: Mild Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (48-72h) | 14.2 Maximum Percentage (%) Change | Standard Error 9.43 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (0-24h) | 96.7 Maximum Percentage (%) Change | Standard Error 11.9 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (24-48h) | 28.7 Maximum Percentage (%) Change | Standard Error 7.91 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (0-24h) | 89.6 Maximum Percentage (%) Change | Standard Error 24.1 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (24-48h) | 4.18 Maximum Percentage (%) Change | Standard Error 9.89 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (48-72h) | -16.0 Maximum Percentage (%) Change | Standard Error 11.5 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (24-48h) | 25.4 Maximum Percentage (%) Change | Standard Error 9.4 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (48-72h) | 4.18 Maximum Percentage (%) Change | Standard Error 10.7 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (48-72h) | -0.439 Maximum Percentage (%) Change | Standard Error 11.9 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Serum Urate Maximum % Change | -20.5 Maximum Percentage (%) Change | Standard Error 2.62 |
| Cohort 2: Moderate Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (0-24h) | 69.3 Maximum Percentage (%) Change | Standard Error 19 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (48-72h) | 9.38 Maximum Percentage (%) Change | Standard Error 21.5 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (24-48h) | 34.5 Maximum Percentage (%) Change | Standard Error 9.17 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (48-72h) | 1.67 Maximum Percentage (%) Change | Standard Error 4.01 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Serum Urate Maximum % Change | -12.6 Maximum Percentage (%) Change | Standard Error 2.62 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (0-24h) | 54.5 Maximum Percentage (%) Change | Standard Error 17 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (48-72h) | 6.02 Maximum Percentage (%) Change | Standard Error 20.2 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (24-48h) | 19.0 Maximum Percentage (%) Change | Standard Error 4.89 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (0-24h) | 72.5 Maximum Percentage (%) Change | Standard Error 17.1 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (24-48h) | 28.3 Maximum Percentage (%) Change | Standard Error 11.2 |
| Cohort 3: Severe Renal Impairment + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (0-24h) | 82.9 Maximum Percentage (%) Change | Standard Error 16.6 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (24-48h) | -1.54 Maximum Percentage (%) Change | Standard Error 12.1 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (48-72h) | -8.12 Maximum Percentage (%) Change | Standard Error 12.2 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (48-72h) | -20.8 Maximum Percentage (%) Change | Standard Error 9.65 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (48-72h) | 2.27 Maximum Percentage (%) Change | Standard Error 8.29 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (24-48h) | 31.9 Maximum Percentage (%) Change | Standard Error 16.8 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Urine Uric Acid % Change (0-24h) | 85.2 Maximum Percentage (%) Change | Standard Error 15.2 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Renal Clearance of Uric Acid % Change (0-24h) | 163 Maximum Percentage (%) Change | Standard Error 30.1 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (0-24h) | 159 Maximum Percentage (%) Change | Standard Error 28.7 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Serum Urate Maximum % Change | -38.3 Maximum Percentage (%) Change | Standard Error 5.24 |
| Cohort 4: Normal Renal Function + RDEA3170 15 mg | Pharmacodynamics (PD) Profiles of Uric Acid From Serum and Urine | Fract. Excretion of Uric Acid % Change (24-48h) | 27.8 Maximum Percentage (%) Change | Standard Error 9.74 |