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CompletedNCT02246673Updated Jul 27, 2017Results posted

RDEA3170 and Febuxostat Combination Study in Gout Subjects

A Phase 2 interventional study of RDEA3170 15 mg and RDEA3170 10 mg in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 6 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2017-07-27.

Sponsored by Ardea Biosciences, Inc. (part of AstraZeneca) · Phase 2, Interventional, and Treatment

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Phase
Phase 2
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 29 studies testing febuxostat in Gout — 1 open to participants now, 1 under way, none of them phase 3. Febuxostat · Gout.

Enrollment
18th of 29
64 · median 109
Started
2014
with 3 others
Phase 2
9 of 29
none open now
Registered
21st of 29
by date
Lead sponsor
1 of 29
Ardea Biosciences, Inc.

Among the 29 studies testing febuxostat in Gout, this one is the 18th largest by enrollment, is one of 4 that started in 2014, is one of 9 in phase 2, and was the 21st registered.

Gout

345 studies on the registry are indexed under Gout; 49 are open to participants now.

Browse Gout studies →

Open to participants now

1 of the 29 studies testing febuxostat in Gout is open now. Recruiting first, the newest first:

About febuxostat

Febuxostat: first FDA approval 2009 (ULORIC), first EMA approval 2008. What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 30 Gout studies recruiting now, 14 (47%) set no upper age limit and 10 (33%) stop at 75 or younger; none take children under 18; none take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 29 studies testing febuxostat in Gout, or all of them as a file.
02

Study 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.

03

Conditions studied

  • Gout

Browse trials for

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Able to understand the study procedures and the risks involved and is willing to provide written 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 ≥ 18 and ≤ 45 kg/m2.
  • Screening serum urate level ≥ 8 mg/dL.
  • Free of any disease or medical condition, per the Investigator's judgment.

Exclusion criteria

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, 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 by the Investigator.
  • Estimated \< 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.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    RDEA3170 10 mg

    Once daily (qd) with febuxostat 40mg (qd) for 7 days, and with febuxostat 80 mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

    Drug: RDEA3170 10 mg · Drug: Febuxostat 40 mg · Drug: Febuxostat 80 mg

  • Experimental
    RDEA3170 15 mg

    Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

    Drug: RDEA3170 15 mg · Drug: RDEA3170 5 mg · Drug: Febuxostat 40 mg · Drug: Febuxostat 80 mg

  • Experimental
    RDEA3170 5 mg

    Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

    Drug: Febuxostat 40 mg · Drug: Febuxostat 80 mg

  • Experimental
    RDEA3170 2.5 mg

    Once daily with febuxostat 40mg (qd) for 7 days and with febuxostat 80mg (qd) for 7 days; febuxostat 40 mg (qd) only for 7 days, and febuxostat 80 mg (qd) only for 7 days.

    Drug: RDEA3170 2.5 · Drug: Febuxostat 40 mg · Drug: Febuxostat 80 mg

06

What researchers measure

Primary outcomes

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

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

    Time frame: 28 days

  2. 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

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

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

    Time frame: 28 days

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

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

    Time frame: 28 days

Secondary outcomes

  1. Maximum Observed Plasma Concentration (Cmax)

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

    Time frame: Days 7 to 28

  2. 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

  3. 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

  4. 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

  5. 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

  6. Incidence of Treatment-Emergent Adverse Events

    Time frame: 10 weeks

07

Results

Posted Jul 27, 2017

Participant flow

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.

Participant flow — Overall Study
MilestoneCohort 1Cohort 2Cohort 3Cohort 4Cohort 5
Started1412121412
Completed1312121211
Not completed10021
Withdrew: Sponsor decision10000
Withdrew: Withdrawal by subject00001
Withdrew: Lost to follow-up00010
Withdrew: Protocol violation00010

Outcome measures

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

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

Time frame:
28 days
Reported as:
Mean · Percentage (%)
Serum Urate Maximum Percentage (%) Change (Emax, CB)
Percentage (%)Febuxostat 40 mgFebuxostat 80 mgRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Serum Urate Maximum Percentage (%) Change (Emax, CB)-43.5 ± 1.10-55.6 ± 1.37-70.4 ± 1.35-79.1 ± 2.53-74.9 ± 1.18-82.4 ± 1.76-59.4 ± 2.81-66.7 ± 2.32-52.5 ± 2.51-62.7 ± 2.69-77.3 ± 1.18
Statistical analysis
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -28.18 · 95% CI -33.85 to -22.51The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -25.29 · 95% CI -31.23 to -19.34The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -29.15 · 95% CI -33.15 to -25.15The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 15 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -22.25 · 95% CI -26.36 to -18.14The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -17.52 · 95% CI -21.54 to -13.50The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -15.51 · 95% CI -19.53 to -11.49The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 2.5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -9.74 · 95% CI -13.97 to -5.51The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 2.5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.0221 · Geometric least squares mean ratio: -4.98 · 95% CI -9.19 to -0.76The model included treatment and period as fixed effects and subject(s) as a random effect
  • Febuxostat 40 mg vs RDEA3170 20 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -35.38 · 95% CI -38.89 to -31.87The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -27.08 · 95% CI -30.60 to -23.57The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: -31.26 · 95% CI -34.77 to -27.75The model included treatment and period as fixed effects and subject(s) as a random effect.
PrimaryUrine Uric Acid % Change (0-24h) (Aeur, CB)

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

Time frame:
28 days
Reported as:
Mean · Percentage (%)
Urine Uric Acid % Change (0-24h) (Aeur, CB)
Percentage (%)Febuxostat 40 mgFebuxostat 80 mgRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Urine Uric Acid % Change (0-24h) (Aeur, CB)-48.6 ± 1.71-60.3 ± 1.58-23.7 ± 5.56-36.6 ± 6.75-22.9 ± 4.15-44.4 ± 5.57-26.2 ± 8.28-39.2 ± 5.95-40.2 ± 4.07-61.1 ± 2.16-14.2 ± 10.9
Statistical analysis
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0002 · Geometric least squares mean ratio: 24.27 · 95% CI 12.57 to 35.98The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.0013 · Geometric least squares mean ratio: 20.08 · 95% CI 8.38 to 31.79The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 23.70 · 95% CI 14.23 to 33.17The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 15 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.0008 · Geometric least squares mean ratio: 18.37 · 95% CI 8.30 to 28.44The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0101 · Geometric least squares mean ratio: 18.82 · 95% CI 4.86 to 32.79The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.0055 · Geometric least squares mean ratio: 20.52 · 95% CI 6.56 to 34.48The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 2.5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0065 · Geometric least squares mean ratio: 10.36 · 95% CI 3.13 to 17.59The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 2.5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.6140 · Geometric least squares mean ratio: 1.79 · 95% CI -5.37 to 8.94The model included treatment and period as fixed effects and subject(s) as a random effect
  • Febuxostat 40 mg vs RDEA3170 20 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0002 · Geometric least squares mean ratio: 30.83 · 95% CI 15.62 to 46.04The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0019 · Geometric least squares mean ratio: 24.38 · 95% CI 9.63 to 39.14The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0009 · Geometric least squares mean ratio: 26.35 · 95% CI 11.59 to 41.11The model included treatment and period as fixed effects and subject(s) as a random effect.
PrimaryRenal Clearance of Uric Acid % Change (0-24h) (CLur, CB)

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

Time frame:
28 days
Reported as:
Mean · Percentage (%)
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)
Percentage (%)Febuxostat 40 mgFebuxostat 80 mgRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB)-15.2 ± 2.53-18.8 ± 2.52125 ± 17.4153 ± 30.5157 ± 15.9172 ± 30.058.7 ± 15.768.4 ± 24.720.9 ± 10.10.011 ± 7.36223 ± 47.0
Statistical analysis
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 139.11 · 95% CI 93.92 to 184.31The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 174.47 · 95% CI 125.52 to 233.42The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 168.03 · 95% CI 123.13 to 212.93The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 15 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 188.75 · 95% CI 138.04 to 239.46The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0005 · Geometric least squares mean ratio: 70.43 · 95% CI 33.74 to 107.12The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 91.50 · 95% CI 54.81 to 128.19The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 2.5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 40.11 · 95% CI 25.17 to 55.05The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 2.5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.0350 · Geometric least squares mean ratio: 15.96 · 95% CI 1.20 to 30.71The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 20 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 236.08 · 95% CI 178.29 to 293.86The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 146.20 · 95% CI 90.40 to 202.01The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 176.57 · 95% CI 120.77 to 232.38The model included treatment and period as fixed effects and subject(s) as a random effect.
PrimaryFract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)

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

Time frame:
28 days
Reported as:
Mean · Percentage (%)
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)
Percentage (%)Febuxostat 40 mgFebuxostat 80 mgRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB)-20.6 ± 1.82-20.8 ± 2.62100 ± 13.4155 ± 32.4133 ± 12.2152 ± 26.246.6 ± 9.3654.8 ± 20.515.2 ± 9.304.73 ± 6.15162 ± 23.2
Statistical analysis
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 135.82 · 95% CI 93.33 to 178.32The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 10 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 178.58 · 95% CI 129.25 to 227.90The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 163.98 · 95% CI 120.80 to 207.16The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 15 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 169.93 · 95% CI 122.82 to 217.03The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = 0.0007 · Geometric least squares mean ratio: 59.60 · 95% CI 28.85 to 90.34The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 73.54 · 95% CI 42.79 to 104.28The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 2.5 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 33.70 · 95% CI 21.21 to 46.20The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 80 mg vs RDEA3170 2.5 mg + Febuxostat 80 mg · Mixed Models Analysis · p = 0.0001 · Geometric least squares mean ratio: 27.08 · 95% CI 14.58 to 39.58The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 20 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 188.83 · 95% CI 152.55 to 225.10The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 10 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 116.83 · 95% CI 81.76 to 151.90The model included treatment and period as fixed effects and subject(s) as a random effect.
  • Febuxostat 40 mg vs RDEA3170 15 mg + Febuxostat 40 mg · Mixed Models Analysis · p = <0.0001 · Geometric least squares mean ratio: 151.66 · 95% CI 116.59 to 186.73The model included treatment and period as fixed effects and subject(s) as a random effect.
SecondaryMaximum Observed Plasma Concentration (Cmax)

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

Time frame:
Days 7 to 28
Reported as:
Geometric mean · ng/mL
Maximum Observed Plasma Concentration (Cmax)
ng/mLRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Maximum Observed Plasma Concentration (Cmax)15.5 (12.9 to 18.6)16.1 (12.6 to 20.6)21.2 (18.0 to 25.1)20.4 (15.8 to 26.2)7.20 (5.55 to 9.34)7.54 (5.69 to 9.99)3.45 (2.63 to 4.52)3.37 (2.42 to 4.68)26.1 (20.1 to 33.9)
SecondaryTime 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
Reported as:
Median · hr
Time of Occurrence of Maximum Observed Concentration (Tmax)
hrRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Time of Occurrence of Maximum Observed Concentration (Tmax)3.00 (1.50 to 10.0)3.00 (1.00 to 12.0)3.00 (1.50 to 8.00)4.00 (2.00 to 6.00)3.50 (2.00 to 6.00)4.00 (1.50 to 12.0)3.50 (1.50 to 8.00)2.50 (1.00 to 10.0)3.00 (1.50 to 6.00)
SecondaryArea 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
Reported as:
Geometric mean · ng·hr/mL
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
ng·hr/mLRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)123 (104 to 146)138 (106 to 179)186 (164 to 212)225 (182 to 278)62.2 (47.8 to 80.8)57.6 (46.8 to 70.9)28.0 (21.2 to 36.9)27.4 (19.7 to 38.1)216 (173 to 270)
SecondaryArea 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
Reported as:
Geometric mean · ng·hr/mL
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
ng·hr/mLRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)123 (104 to 146)138 (106 to 179)186 (164 to 212)225 (182 to 278)62.2 (47.8 to 80.8)62.6 (48.2 to 81.3)28.0 (21.2 to 36.9)26.8 (18.8 to 38.3)216 (173 to 270)
SecondaryApparent Terminal Half-life (t1/2)

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

Time frame:
Days 7 to 28
Reported as:
Geometric mean · hr
Apparent Terminal Half-life (t1/2)
hrRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Apparent Terminal Half-life (t1/2)8.26 (6.71 to 10.2)9.64 (6.77 to 13.7)10.6 (8.41 to 13.3)10.8 (8.17 to 14.3)13.2 (8.11 to 21.4)11.3 (7.09 to 18.1)13.0 (8.89 to 19.1)12.5 (8.18 to 19.2)11.6 (7.17 to 18.8)
SecondaryIncidence of Treatment-Emergent Adverse Events
Time frame:
10 weeks
Reported as:
Number · Number of participants
Incidence of Treatment-Emergent Adverse Events
Number of participantsFebuxostat 40 mgFebuxostat 80 mgRDEA3170 10 mg + Febuxostat 40 mgRDEA3170 10 mg + Febuxostat 80 mgRDEA3170 15 mg + Febuxostat 40 mgRDEA3170 15 mg + Febuxostat 80 mgRDEA3170 5 mg + Febuxostat 40 mgRDEA3170 5 mg + Febuxostat 80 mgRDEA3170 2.5 mg + Febuxostat 40 mgRDEA3170 2.5 mg + Febuxostat 80 mgRDEA3170 20 mg + Febuxostat 40 mg
Incidence of Treatment-Emergent Adverse Events38461001102

Adverse events

Collected over 10 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Febuxostat 40 mg—0/61 (0%)3/61 (4.9%)
Febuxostat 80 mg—0/51 (0%)8/51 (15.7%)
Overall RDEA3170 + Febuxostat Combination—0/62 (0%)13/62 (21%)
Most frequent other events
Showing 10 of 23
Most frequent other events
EventFebuxostat 40 mgFebuxostat 80 mgOverall RDEA3170 + Febuxostat Combination
Pain In ExtremityMusculoskeletal and connective tissue disorders0/610/513/62
DyspepsiaGastrointestinal disorders1/610/512/62
Musculoskeletal PainMusculoskeletal and connective tissue disorders0/610/512/62
HepatitisHepatobiliary disorders0/611/510/62
Hepatitis AcuteHepatobiliary disorders0/611/510/62
Decreased AppetiteMetabolism and nutrition disorders0/611/510/62
HypertriglyceridaemiaMetabolism and nutrition disorders0/611/510/62
HeadacheNervous system disorders0/611/511/62
Tympanic Membrane HyperaemiaEar and labyrinth disorders0/611/510/62
ExcoriationInjury, poisoning and procedural complications0/611/510/62

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Mean45 ± 8.950 ± 8.250 ± 8.548 ± 11.549 ± 10.948 ± 9.6
Sex: Female, Male
Sex: Female, Male(Participants)Cohort 1Cohort 2Cohort 3Cohort 4Cohort 5Total
Female000000
Male141212141264
08

Study locations

6 sites
  • Anaheim, California 92801, United States
  • Glendale, California 91206, United States
  • South Miami, Florida 33143, United States
  • Overland Park, Kansas 66211, United States
  • Overland Park, Kansas 66212, United States
  • Dallas, Texas 75231, United States
09

References and documents

Publications

  • Rekic D, Johansson S, Leander J. Higher Febuxostat Exposure Observed in Asian Compared with Caucasian Subjects Independent of Bodyweight. Clin Pharmacokinet. 2021 Mar;60(3):319-328. doi: 10.1007/s40262-020-00943-6. Epub 2020 Sep 19. PubMed 32951150 ↗
  • Fleischmann R, Winkle P, Hall J, Valdez S, Liu S, Yan X, Hicks L, Lee C, Miner JN, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with febuxostat in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Apr 9;4(1):e000647. doi: 10.1136/rmdopen-2018-000647. eCollection 2018. PubMed 29657831 ↗
10

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Oct 2014, a primary completion of Jul 2015 and a completion of Feb 2016. It does not say whether these dates are actual or estimated.

Results were first posted in Jul 2017, 2 years after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2014
First posted
Sep 23, 2014
Start
Oct 2014
Primary completionActual
Jul 2015
CompletionActual
Feb 2016
Results first posted
Jul 27, 2017
Last update
Jul 27, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 27, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02246673
Lead sponsor
Ardea Biosciences, Inc.
Responsible party
Sponsor
First posted
Sep 23, 2014
Start date
Oct 2014
Primary completion
Jul 2015
Completion
Feb 2016
Results posted
Jul 27, 2017
Last update
Jul 27, 2017

Study contacts

J. Hall
study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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