RDEA3170 and Febuxostat Combination Study in Gout Subjects

A Phase 2a, Randomized, Open-Label Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to Febuxostat Administered Alone in Adult Subjects With Gout

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02246673

Enrollment

Registered

2014-09-23

Start date

2014-10-31

Completion date

2016-02-29

Last updated

2017-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gout

Brief summary

This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects and safety of RDEA3170 administered in combination with febuxostat compared to febuxostat administered alone in adult subjects with gout.

Interventions

DRUGRDEA3170 15 mg

DRUGRDEA3170 10 mg

DRUGRDEA3170 2.5

DRUGRDEA3170 5 mg

DRUGFebuxostat 40 mg

DRUGFebuxostat 80 mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study-related activity. * Meets one or more criteria for the diagnosis of gout as per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout. * Body weight ≥ 50 kg (110 lbs) and a body mass index ≥ 18 and ≤ 45 kg/m2. * Screening serum urate level ≥ 8 mg/dL. * Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion criteria

* Unable to take colchicine for gout flare prophylaxis. * History or suspicion of kidney stones. * Any gastrointestinal disorder that affects motility and/or absorption. * Unstable angina, New York Heart Association class III or IV heart failure, ischemic heart disease, stroke, or deep venous thrombosis within 12 months prior to Day 1; or subject is currently receiving anticoagulants. * Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator. * Estimated creatinine clearance \< 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period. * Taking losartan, fenofibrate, guaifenesin, or sodium-glucose linked transporter-2 inhibitors; chronic and stable doses are permitted if doses are stable for at least 14 days prior to study medication dosing. * 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.

Design outcomes

Primary

Measure	Time frame	Description
Serum Urate Maximum Percentage (%) Change (Emax, CB)	28 days	Maximum observed percentage (%) change from baseline in serum urate concentrations.
Urine Uric Acid % Change (0-24h) (Aeur, CB)	28 days	Percentage (%) change from baseline in the amount of uric acid recovered in urine.
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	28 days	Percentage (%) change from baseline in renal clearance of uric acid.
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	28 days	Percentage (%) change from baseline in fractional excretion of uric acid.

Secondary

Measure	Time frame	Description
Apparent Terminal Half-life (t1/2)	Days 7 to 28	t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Maximum Observed Plasma Concentration (Cmax)	Days 7 to 28	Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Incidence of Treatment-Emergent Adverse Events	10 weeks	—
Time of Occurrence of Maximum Observed Concentration (Tmax)	Days 7 to 28	Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	Days 7 to 28	AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	Days 7 to 28	AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

Countries

United States

Participant flow

Recruitment details

Sixty-four subjects were randomized and received at least 1 dose of randomized study medication. Five cohorts of approximately 12 adult subjects with gout per cohort were randomized into the study. Overall, a total of 60 subjects completed the study in accordance with the protocol.

Pre-assignment details

Cohorts 1 through 4 were conducted sequentially and Cohort 5 was conducted following review of the available PD/PK results of Cohort 2. Subjects in Cohorts 1 through 4 were randomized to 1 of 2 treatment sequences (ABCD or DCBA) in a 1:1 ration and subjects in Cohort 5 were randomized to 1 of 2 treatment sequences (EHGF or GFHE) in a 1:1 ratio.

Participants by arm

Arm	Count
Cohort 1	14
Cohort 2	12
Cohort 3	12
Cohort 4	14
Cohort 5	12
Total	64

Withdrawals & dropouts

Period	Reason	FG000	FG003	FG004
Overall Study	Lost to Follow-up	0	1	0
Overall Study	Protocol Violation	0	1	0
Overall Study	Sponsor Decision	1	0	0
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Cohort 1	Cohort 2	Cohort 3	Cohort 4	Cohort 5	Total
Age, Continuous	45 Years STANDARD_DEVIATION 8.9	50 Years STANDARD_DEVIATION 8.2	50 Years STANDARD_DEVIATION 8.5	48 Years STANDARD_DEVIATION 11.5	49 Years STANDARD_DEVIATION 10.9	48 Years STANDARD_DEVIATION 9.6
Sex: Female, Male Female	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants
Sex: Female, Male Male	14 Participants	12 Participants	12 Participants	14 Participants	12 Participants	64 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	3 / 61	8 / 51	13 / 62
serious Total, serious adverse events	0 / 61	0 / 51	0 / 62

Outcome results

Primary

Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)

Percentage (%) change from baseline in fractional excretion of uric acid.

Time frame: 28 days

Arm	Measure	Value (MEAN)	Dispersion
Febuxostat 40 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	-20.6 Percentage (%)	Standard Error 1.82
Febuxostat 80 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	-20.8 Percentage (%)	Standard Error 2.62
RDEA3170 10 mg + Febuxostat 40 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	100 Percentage (%)	Standard Error 13.4
RDEA3170 10 mg + Febuxostat 80 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	155 Percentage (%)	Standard Error 32.4
RDEA3170 15 mg + Febuxostat 40 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	133 Percentage (%)	Standard Error 12.2
RDEA3170 15 mg + Febuxostat 80 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	152 Percentage (%)	Standard Error 26.2
RDEA3170 5 mg + Febuxostat 40 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	46.6 Percentage (%)	Standard Error 9.36
RDEA3170 5 mg + Febuxostat 80 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	54.8 Percentage (%)	Standard Error 20.5
RDEA3170 2.5 mg + Febuxostat 40 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	15.2 Percentage (%)	Standard Error 9.3
RDEA3170 2.5 mg + Febuxostat 80 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	4.73 Percentage (%)	Standard Error 6.15
RDEA3170 20 mg + Febuxostat 40 mg	Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)	162 Percentage (%)	Standard Error 23.2

Comparison: Cohort 1p-value: <0.000195% CI: [93.33, 178.32]Mixed Models Analysis

Comparison: Cohort 1p-value: <0.000195% CI: [129.25, 227.9]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [120.8, 207.16]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [122.82, 217.03]Mixed Models Analysis

Comparison: Cohort 3p-value: 0.000795% CI: [28.85, 90.34]Mixed Models Analysis

Comparison: Cohort 3p-value: <0.000195% CI: [42.79, 104.28]Mixed Models Analysis

Comparison: Cohort 4p-value: <0.000195% CI: [21.21, 46.2]Mixed Models Analysis

Comparison: Cohort 4p-value: 0.000195% CI: [14.58, 39.58]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [152.55, 225.1]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [81.76, 151.9]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [116.59, 186.73]Mixed Models Analysis

Primary

Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)

Percentage (%) change from baseline in renal clearance of uric acid.

Time frame: 28 days

Arm	Measure	Value (MEAN)	Dispersion
Febuxostat 40 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	-15.2 Percentage (%)	Standard Error 2.53
Febuxostat 80 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	-18.8 Percentage (%)	Standard Error 2.52
RDEA3170 10 mg + Febuxostat 40 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	125 Percentage (%)	Standard Error 17.4
RDEA3170 10 mg + Febuxostat 80 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	153 Percentage (%)	Standard Error 30.5
RDEA3170 15 mg + Febuxostat 40 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	157 Percentage (%)	Standard Error 15.9
RDEA3170 15 mg + Febuxostat 80 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	172 Percentage (%)	Standard Error 30
RDEA3170 5 mg + Febuxostat 40 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	58.7 Percentage (%)	Standard Error 15.7
RDEA3170 5 mg + Febuxostat 80 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	68.4 Percentage (%)	Standard Error 24.7
RDEA3170 2.5 mg + Febuxostat 40 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	20.9 Percentage (%)	Standard Error 10.1
RDEA3170 2.5 mg + Febuxostat 80 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	0.011 Percentage (%)	Standard Error 7.36
RDEA3170 20 mg + Febuxostat 40 mg	Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)	223 Percentage (%)	Standard Error 47

Comparison: Cohort 1p-value: <0.000195% CI: [93.92, 184.31]Mixed Models Analysis

Comparison: Cohort 1p-value: <0.000195% CI: [125.52, 233.42]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [123.13, 212.93]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [138.04, 239.46]Mixed Models Analysis

Comparison: Cohort 3p-value: 0.000595% CI: [33.74, 107.12]Mixed Models Analysis

Comparison: Cohort 3p-value: <0.000195% CI: [54.81, 128.19]Mixed Models Analysis

Comparison: Cohort 4p-value: <0.000195% CI: [25.17, 55.05]Mixed Models Analysis

Comparison: Cohort 4p-value: 0.03595% CI: [1.2, 30.71]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [178.29, 293.86]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [90.4, 202.01]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [120.77, 232.38]Mixed Models Analysis

Primary

Serum Urate Maximum Percentage (%) Change (Emax, CB)

Maximum observed percentage (%) change from baseline in serum urate concentrations.

Time frame: 28 days

Arm	Measure	Value (MEAN)	Dispersion
Febuxostat 40 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-43.5 Percentage (%)	Standard Error 1.1
Febuxostat 80 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-55.6 Percentage (%)	Standard Error 1.37
RDEA3170 10 mg + Febuxostat 40 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-70.4 Percentage (%)	Standard Error 1.35
RDEA3170 10 mg + Febuxostat 80 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-79.1 Percentage (%)	Standard Error 2.53
RDEA3170 15 mg + Febuxostat 40 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-74.9 Percentage (%)	Standard Error 1.18
RDEA3170 15 mg + Febuxostat 80 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-82.4 Percentage (%)	Standard Error 1.76
RDEA3170 5 mg + Febuxostat 40 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-59.4 Percentage (%)	Standard Error 2.81
RDEA3170 5 mg + Febuxostat 80 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-66.7 Percentage (%)	Standard Error 2.32
RDEA3170 2.5 mg + Febuxostat 40 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-52.5 Percentage (%)	Standard Error 2.51
RDEA3170 2.5 mg + Febuxostat 80 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-62.7 Percentage (%)	Standard Error 2.69
RDEA3170 20 mg + Febuxostat 40 mg	Serum Urate Maximum Percentage (%) Change (Emax, CB)	-77.3 Percentage (%)	Standard Error 1.18

Comparison: Cohort 3p-value: <0.000195% CI: [-21.54, -13.5]Mixed Models Analysis

Comparison: Cohort 3p-value: <0.000195% CI: [-19.53, -11.49]Mixed Models Analysis

Comparison: Cohort 4p-value: <0.000195% CI: [-13.97, -5.51]Mixed Models Analysis

Comparison: Cohort 1p-value: <0.000195% CI: [-33.85, -22.51]Mixed Models Analysis

Comparison: Cohort 1p-value: <0.000195% CI: [-31.23, -19.34]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [-33.15, -25.15]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [-26.36, -18.14]Mixed Models Analysis

Comparison: Cohort 4p-value: 0.022195% CI: [-9.19, -0.76]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [-38.89, -31.87]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [-30.6, -23.57]Mixed Models Analysis

Comparison: Cohort 5p-value: <0.000195% CI: [-34.77, -27.75]Mixed Models Analysis

Primary

Urine Uric Acid % Change (0-24h) (Aeur, CB)

Percentage (%) change from baseline in the amount of uric acid recovered in urine.

Time frame: 28 days

Arm	Measure	Value (MEAN)	Dispersion
Febuxostat 40 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-48.6 Percentage (%)	Standard Error 1.71
Febuxostat 80 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-60.3 Percentage (%)	Standard Error 1.58
RDEA3170 10 mg + Febuxostat 40 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-23.7 Percentage (%)	Standard Error 5.56
RDEA3170 10 mg + Febuxostat 80 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-36.6 Percentage (%)	Standard Error 6.75
RDEA3170 15 mg + Febuxostat 40 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-22.9 Percentage (%)	Standard Error 4.15
RDEA3170 15 mg + Febuxostat 80 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-44.4 Percentage (%)	Standard Error 5.57
RDEA3170 5 mg + Febuxostat 40 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-26.2 Percentage (%)	Standard Error 8.28
RDEA3170 5 mg + Febuxostat 80 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-39.2 Percentage (%)	Standard Error 5.95
RDEA3170 2.5 mg + Febuxostat 40 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-40.2 Percentage (%)	Standard Error 4.07
RDEA3170 2.5 mg + Febuxostat 80 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-61.1 Percentage (%)	Standard Error 2.16
RDEA3170 20 mg + Febuxostat 40 mg	Urine Uric Acid % Change (0-24h) (Aeur, CB)	-14.2 Percentage (%)	Standard Error 10.9

Comparison: Cohort 1p-value: 0.000295% CI: [12.57, 35.98]Mixed Models Analysis

Comparison: Cohort 1p-value: 0.001395% CI: [8.38, 31.79]Mixed Models Analysis

Comparison: Cohort 2p-value: <0.000195% CI: [14.23, 33.17]Mixed Models Analysis

Comparison: Cohort 2p-value: 0.000895% CI: [8.3, 28.44]Mixed Models Analysis

Comparison: Cohort 3p-value: 0.010195% CI: [4.86, 32.79]Mixed Models Analysis

Comparison: Cohort 3p-value: 0.005595% CI: [6.56, 34.48]Mixed Models Analysis

Comparison: Cohort 4p-value: 0.006595% CI: [3.13, 17.59]Mixed Models Analysis

Comparison: Cohort 4p-value: 0.61495% CI: [-5.37, 8.94]Mixed Models Analysis

Comparison: Cohort 5p-value: 0.000295% CI: [15.62, 46.04]Mixed Models Analysis

Comparison: Cohort 5p-value: 0.001995% CI: [9.63, 39.14]Mixed Models Analysis

Comparison: Cohort 5p-value: 0.000995% CI: [11.59, 41.11]Mixed Models Analysis

Secondary

Apparent Terminal Half-life (t1/2)

t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

Time frame: Days 7 to 28

Arm	Measure	Value (GEOMETRIC_MEAN)
Febuxostat 40 mg	Apparent Terminal Half-life (t1/2)	8.26 hr
Febuxostat 80 mg	Apparent Terminal Half-life (t1/2)	9.64 hr
RDEA3170 10 mg + Febuxostat 40 mg	Apparent Terminal Half-life (t1/2)	10.6 hr
RDEA3170 10 mg + Febuxostat 80 mg	Apparent Terminal Half-life (t1/2)	10.8 hr
RDEA3170 15 mg + Febuxostat 40 mg	Apparent Terminal Half-life (t1/2)	13.2 hr
RDEA3170 15 mg + Febuxostat 80 mg	Apparent Terminal Half-life (t1/2)	11.3 hr
RDEA3170 5 mg + Febuxostat 40 mg	Apparent Terminal Half-life (t1/2)	13.0 hr
RDEA3170 5 mg + Febuxostat 80 mg	Apparent Terminal Half-life (t1/2)	12.5 hr
RDEA3170 2.5 mg + Febuxostat 40 mg	Apparent Terminal Half-life (t1/2)	11.6 hr

Secondary

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

Time frame: Days 7 to 28

Arm	Measure	Value (GEOMETRIC_MEAN)
Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	123 ng·hr/mL
Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	138 ng·hr/mL
RDEA3170 10 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	186 ng·hr/mL
RDEA3170 10 mg + Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	225 ng·hr/mL
RDEA3170 15 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	62.2 ng·hr/mL
RDEA3170 15 mg + Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	62.6 ng·hr/mL
RDEA3170 5 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	28.0 ng·hr/mL
RDEA3170 5 mg + Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	26.8 ng·hr/mL
RDEA3170 2.5 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)	216 ng·hr/mL

Secondary

Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

Time frame: Days 7 to 28

Arm	Measure	Value (GEOMETRIC_MEAN)
Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	123 ng·hr/mL
Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	138 ng·hr/mL
RDEA3170 10 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	186 ng·hr/mL
RDEA3170 10 mg + Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	225 ng·hr/mL
RDEA3170 15 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	62.2 ng·hr/mL
RDEA3170 15 mg + Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	57.6 ng·hr/mL
RDEA3170 5 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	28.0 ng·hr/mL
RDEA3170 5 mg + Febuxostat 80 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	27.4 ng·hr/mL
RDEA3170 2.5 mg + Febuxostat 40 mg	Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)	216 ng·hr/mL

Secondary

Incidence of Treatment-Emergent Adverse Events

Time frame: 10 weeks

Arm	Measure	Value (NUMBER)
Febuxostat 40 mg	Incidence of Treatment-Emergent Adverse Events	3 Number of participants
Febuxostat 80 mg	Incidence of Treatment-Emergent Adverse Events	8 Number of participants
RDEA3170 10 mg + Febuxostat 40 mg	Incidence of Treatment-Emergent Adverse Events	4 Number of participants
RDEA3170 10 mg + Febuxostat 80 mg	Incidence of Treatment-Emergent Adverse Events	6 Number of participants
RDEA3170 15 mg + Febuxostat 40 mg	Incidence of Treatment-Emergent Adverse Events	1 Number of participants
RDEA3170 15 mg + Febuxostat 80 mg	Incidence of Treatment-Emergent Adverse Events	0 Number of participants
RDEA3170 5 mg + Febuxostat 40 mg	Incidence of Treatment-Emergent Adverse Events	0 Number of participants
RDEA3170 5 mg + Febuxostat 80 mg	Incidence of Treatment-Emergent Adverse Events	1 Number of participants
RDEA3170 2.5 mg + Febuxostat 40 mg	Incidence of Treatment-Emergent Adverse Events	1 Number of participants
RDEA3170 2.5 mg + Febuxostat 80 mg	Incidence of Treatment-Emergent Adverse Events	0 Number of participants
RDEA3170 20 mg + Febuxostat 40 mg	Incidence of Treatment-Emergent Adverse Events	2 Number of participants

Secondary

Maximum Observed Plasma Concentration (Cmax)

Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

Time frame: Days 7 to 28

Arm	Measure	Value (GEOMETRIC_MEAN)
Febuxostat 40 mg	Maximum Observed Plasma Concentration (Cmax)	15.5 ng/mL
Febuxostat 80 mg	Maximum Observed Plasma Concentration (Cmax)	16.1 ng/mL
RDEA3170 10 mg + Febuxostat 40 mg	Maximum Observed Plasma Concentration (Cmax)	21.2 ng/mL
RDEA3170 10 mg + Febuxostat 80 mg	Maximum Observed Plasma Concentration (Cmax)	20.4 ng/mL
RDEA3170 15 mg + Febuxostat 40 mg	Maximum Observed Plasma Concentration (Cmax)	7.20 ng/mL
RDEA3170 15 mg + Febuxostat 80 mg	Maximum Observed Plasma Concentration (Cmax)	7.54 ng/mL
RDEA3170 5 mg + Febuxostat 40 mg	Maximum Observed Plasma Concentration (Cmax)	3.45 ng/mL
RDEA3170 5 mg + Febuxostat 80 mg	Maximum Observed Plasma Concentration (Cmax)	3.37 ng/mL
RDEA3170 2.5 mg + Febuxostat 40 mg	Maximum Observed Plasma Concentration (Cmax)	26.1 ng/mL

Secondary

Time of Occurrence of Maximum Observed Concentration (Tmax)

Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

Time frame: Days 7 to 28

Arm	Measure	Value (MEDIAN)
Febuxostat 40 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	3.00 hr
Febuxostat 80 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	3.00 hr
RDEA3170 10 mg + Febuxostat 40 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	3.00 hr
RDEA3170 10 mg + Febuxostat 80 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	4.00 hr
RDEA3170 15 mg + Febuxostat 40 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	3.50 hr
RDEA3170 15 mg + Febuxostat 80 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	4.00 hr
RDEA3170 5 mg + Febuxostat 40 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	3.50 hr
RDEA3170 5 mg + Febuxostat 80 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	2.50 hr
RDEA3170 2.5 mg + Febuxostat 40 mg	Time of Occurrence of Maximum Observed Concentration (Tmax)	3.00 hr

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026

RDEA3170 and Febuxostat Combination Study in Gout Subjects

Conditions

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Recruitment details

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)

Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)

Serum Urate Maximum Percentage (%) Change (Emax, CB)

Urine Uric Acid % Change (0-24h) (Aeur, CB)

Apparent Terminal Half-life (t1/2)

Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

Incidence of Treatment-Emergent Adverse Events

Maximum Observed Plasma Concentration (Cmax)

Time of Occurrence of Maximum Observed Concentration (Tmax)