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CompletedNCT02498652Updated Jan 23, 2018Results posted

Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

A Phase 2 interventional study of RDEA3170 2.5 mg and allopurinol 300 mg in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 4 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2018-01-23.

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

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Phase
Phase 2
Study type
Interventional
Enrollment
41
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 16 studies testing allopurinol in Gout — 1 open to participants now, 1 under way, none of them phase 3. Allopurinol · Gout.

Enrollment
10th of 16
41 · median 46
Started
2015
with 1 other
Phase 2
6 of 16
none open now
Registered
11th of 16
by date
Lead sponsor
5 of 16
Ardea Biosciences, Inc.

Among the 16 studies testing allopurinol in Gout, this one is the 10th largest by enrollment, is one of 2 that started in 2015, is one of 6 in phase 2, and was the 11th 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 16 studies testing allopurinol in Gout is open now. Recruiting first, the newest first:

About allopurinol

Allopurinol: first FDA approval 1966 (ZYLOPRIM), first EMA approval 2018. 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 →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies testing allopurinol 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 of RDEA3170 administered in combination with allopurinol compared with allopurinol 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

  • Subject is able to understand the study procedures and the risks involved and is willing to provide written before the first study-related activity.
  • Subject 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.
  • Subject has a body weight ≥ 50 kg (110 lbs.) and a ≥ 18 and ≤ 45 kg/m2.
  • Subject has a Screening serum urate level ≥ 8 mg/dL.
  • Subject is free of any disease or medical condition, per the Investigator's judgment.

Exclusion criteria

Exclusion Criteria:

  • Subject is unable to take colchicine for gout flare prophylaxis.
  • Subject has a history or suspicion of kidney stones.
  • Subject has any gastrointestinal disorder that affects motility and/or absorption.
  • Subject had 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.
  • Subject has Screening laboratory parameters that are outside the normal limits and are considered by the Investigator.
  • Subject has an estimated \< 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight during the Screening period.
  • Subject is 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.
  • Subject is 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
41 participants (actual)

Study arms

  • Experimental
    RDEA3170 2.5 mg, 7.5 mg and 15 mg

    RDEA3170 2.5 mg, 7.5 mg and 15 mg once daily (qd) in combination with allopurinol 300 mg (qd and twice daily (bid))

    Drug: RDEA3170 2.5 mg · Drug: allopurinol 300 mg

  • Experimental
    RDEA3170 5 mg, 10 mg and 20 mg

    RDEA3170 5 mg, 10 mg 20 mg qd in combination with allopurinol 300 mg (qd and bid)

    Drug: RDEA3170 2.5 mg · Drug: allopurinol 300 mg

Interventions

  • DrugRDEA3170 2.5 mg

    Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets). Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets).

  • Drugallopurinol 300 mg

    allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)

06

What researchers measure

Primary outcomes

  1. Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  2. Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  3. Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  4. Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  5. Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  6. Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  7. Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

  8. Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))

    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

    Time frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)

Secondary outcomes

  1. Maximum Observed Concentration (Cmax)

    Cmax of Allopurinol alone or in combination with RDEA3170

    Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)

  2. Time of Occurrence of Maximum Observed Concentration (Tmax)

    Tmax of Allopurinol alone or in combination with RDEA3170

    Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)

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

    AUC 0-24 of Allopurinol alone or in combination with RDEA3170

    Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)

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

    AUC last of Allopurinol alone or in combination with RDEA3170

    Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)

  5. Apparent Terminal Half-life (t1/2)

    t1/2 of Allopurinol alone or in combination with RDEA3170

    Time frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)

  6. Number of Participants With Treatment-Emergent Adverse Events

    Time frame: 11 weeks

07

Results

Posted Jan 23, 2018
Limitations and caveats
Reliable urine uric acid values were not obtained due to sample processing errors, and this has resulted in the inability to assess the PD effects of RDEA3170 and/or allopurinol in urine.

Participant flow

41 subjects were randomized.

Participant flow — Overall Study
MilestoneCohort 1Cohort 2
Started2021
Completed2020
Not completed01
Withdrew: Protocol violation01

Outcome measures

PrimaryCohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · Maximum Percentage (%) Change
Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Maximum Percentage (%) ChangeTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R3Treatment R5
Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))-40.2 ± 3.29-55.0 ± 4.96-56.8 ± 4.52-48.1 ± 2.91-61.0 ± 2.59-69.5 ± 2.09
PrimaryCohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · mg/dL
Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
mg/dLTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R3Treatment R5
Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.5.8 ± 0.244.8 ± 0.384.0 ± 0.395.5 ± 0.244.6 ± 0.223.8 ± 0.18
PrimaryCohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · Percentage (%) Change
Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Percentage (%) ChangeTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R3Treatment R5
Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))1065 ± 1381827 ± 2522633 ± 255899 ± 116958 ± 128827 ± 106
PrimaryCohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · Percentage (%) Change
Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Percentage (%) ChangeTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R3Treatment R5
Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))400 ± 74.6517 ± 106827 ± 136310 ± 55.5311 ± 51.8305 ± 54.7
PrimaryCohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · Maximum Percentage (%) Change
Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))
Maximum Percentage (%) ChangeTreatment A1Treatment A2qTreatment A2bTreatment R2Treatment R4Treatment R6
Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%))-39.3 ± 1.78-54.4 ± 4.50-50.3 ± 4.15-57.8 ± 1.61-66.0 ± 1.86-73.2 ± 1.75
SecondaryMaximum Observed Concentration (Cmax)

Cmax of Allopurinol alone or in combination with RDEA3170

Time frame:
Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Reported as:
Geometric mean · µg/mL
Maximum Observed Concentration (Cmax)
µg/mLTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R2Treatment R3Treatment R4Treatment R5Treatment R6
Maximum Observed Concentration (Cmax)1.18 (1.03 to 1.36)2.43 (1.94 to 3.04)1.19 (0.997 to 1.42)1.16 (0.911 to 1.47)1.16 (0.937 to 1.43)1.14 (0.905 to 1.44)1.11 (0.928 to 1.33)1.12 (0.877 to 1.44)1.26 (1.02 to 1.56)
Statistical analysis
  • Treatment A1 vs Treatment R1 · Mixed Models Analysis · Geometric least squares mean ratio (%): 103 · 90% CI 90.7 to 117Fixed effect for treatment and random effects for subjects.
  • Treatment A1 vs Treatment R2 · Mixed Models Analysis · Geometric least squares mean ratio (%): 92.6 · 90% CI 78.1 to 110Fixed effect for treatment and random effects for subjects.
  • Treatment A1 vs Treatment R3 · Mixed Models Analysis · Geometric least squares mean ratio (%): 102 · 90% CI 85.7 to 120Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R4 · Mixed Models Analysis · Geometric least squares mean ratio (%): 88.9 · 90% CI 78.4 to 101Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R5 · Mixed Models Analysis · Geometric least squares mean ratio (%): 100 · 90% CI 87.7 to 114Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale
  • Treatment A1 vs Treatment R6 · Mixed Models Analysis · Geometric least squares mean ratio (%): 101 · 90% CI 85.5 to 119Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
SecondaryTime of Occurrence of Maximum Observed Concentration (Tmax)

Tmax of Allopurinol alone or in combination with RDEA3170

Time frame:
Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Reported as:
Geometric mean · hr
Time of Occurrence of Maximum Observed Concentration (Tmax)
hrTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R2Treatment R3Treatment R4Treatment R5Treatment R6
Time of Occurrence of Maximum Observed Concentration (Tmax)1.50 (0.500 to 6.02)2.98 (0.983 to 4.00)2.02 (0.500 to 8.00)2.01 (0.967 to 6.00)2.49 (0.500 to 3.97)1.73 (0.500 to 6.00)2.98 (0.500 to 6.02)1.73 (0.500 to 6.00)1.97 (0.500 to 4.03)
SecondaryArea Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)

AUC 0-24 of Allopurinol alone or in combination with RDEA3170

Time frame:
Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Reported as:
Geometric mean · µg·hr/mL
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)
µg·hr/mLTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R2Treatment R3Treatment R4Treatment R5Treatment R6
Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24)3.94 (3.52 to 4.42)11.0 (8.87 to 13.7)8.64 (7.13 to 10.5)4.06 (3.24 to 5.10)4.10 (3.53 to 4.77)3.81 (3.13 to 4.64)3.83 (3.15 to 4.65)3.88 (3.15 to 4.77)3.82 (3.27 to 4.46)
SecondaryArea Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)

AUC last of Allopurinol alone or in combination with RDEA3170

Time frame:
Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Reported as:
Geometric mean · µg·hr/mL
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)
µg·hr/mLTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R2Treatment R3Treatment R4Treatment R5Treatment R6
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last)3.70 (3.28 to 4.18)10.9 (8.74 to 13.5)4.25 (3.57 to 5.07)3.59 (2.87 to 4.49)3.76 (3.20 to 4.41)3.71 (3.04 to 4.54)3.53 (2.84 to 4.39)3.74 (3.21 to 4.34)3.74 (3.21 to 4.34)
Statistical analysis
  • Treatment A1 vs Treatment R1 · Mixed Models Analysis · Geometric least squares mean ratio (%): 100 · 90% CI 94.3 to 107Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R2 · Mixed Models Analysis · Geometric least squares mean ratio (%): 98.0 · 90% CI 90.4 to 106Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R3 · Mixed Models Analysis · Geometric least squares mean ratio (%): 104 · 90% CI 94.5 to 114Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R4 · Mixed Models Analysis · Geometric least squares mean ratio (%): 92.0 · 90% CI 86.7 to 97.7Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R5 · Mixed Models Analysis · Geometric least squares mean ratio (%): 98.9 · 90% CI 91.0 to 107Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
  • Treatment A1 vs Treatment R6 · Mixed Models Analysis · Geometric least squares mean ratio (%): 97.5 · 90% CI 92.8 to 102Fixed effect for treatment and random effects for subjects. GLMSRs are back-transformed to the original scale.
SecondaryApparent Terminal Half-life (t1/2)

t1/2 of Allopurinol alone or in combination with RDEA3170

Time frame:
Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose)
Reported as:
Geometric mean · hr
Apparent Terminal Half-life (t1/2)
hrTreatment A1Treatment A2qTreatment A2bTreatment R1Treatment R2Treatment R3Treatment R4Treatment R5Treatment R6
Apparent Terminal Half-life (t1/2)1.21 (1.14 to 1.27)1.47 (1.33 to 1.62)1.25 (1.13 to 1.38)1.20 (1.10 to 1.30)1.14 (1.03 to 1.25)1.17 (1.10 to 1.25)1.16 (1.08 to 1.24)1.13 (1.04 to 1.22)1.13 (1.03 to 1.24)
SecondaryNumber of Participants With Treatment-Emergent Adverse Events
Time frame:
11 weeks
Reported as:
Number · Number of participants
Number of Participants With Treatment-Emergent Adverse Events
Number of participantsCohort 1Cohort 2
Number of Participants With Treatment-Emergent Adverse Events66
PrimaryCohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · mg/dL
Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.
mg/dLTreatment A1Treatment A2qTreatment A2bTreatment R2Treatment R4Treatment R6
Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol.6.2 ± 0.225.0 ± 0.614.6 ± 0.334.8 ± 0.224.1 ± 0.223.5 ± 0.20
PrimaryCohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · Percentage (%) Change
Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))
Percentage (%) ChangeTreatment A1Treatment A2qTreatment A2bTreatment R2Treatment R4Treatment R6
Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%))952 ± 77.22027 ± 2032138 ± 164812 ± 76.3797 ± 65.7816 ± 71.1
PrimaryCohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))

Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

Time frame:
Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose)
Reported as:
Mean · Percentage (%) Change
Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))
Percentage (%) ChangeTreatment A1Treatment A2qTreatment A2bTreatment R2Treatment R4Treatment R6
Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%))372 ± 33.9645 ± 76.9681 ± 63.9268 ± 24.1267 ± 23.4286 ± 25.6

Adverse events

Collected over 11 Weeks.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Cohort 10/20 (0%)1/20 (5%)6/20 (30%)
Cohort 20/21 (0%)0/21 (0%)6/21 (28.6%)
Most frequent serious events
Most frequent serious events
EventCohort 1Cohort 2
Pneumonia AspirationRespiratory, thoracic and mediastinal disorders1/200/21
Most frequent other events
Showing 10 of 14
Most frequent other events
EventCohort 1Cohort 2
HeadacheNervous system disorders0/203/21
Upper Respiratory Tract InfectionInfections and infestations2/202/21
Musculoskeletal PainMusculoskeletal and connective tissue disorders0/202/21
SinusitisInfections and infestations1/200/21
EpistaxisRespiratory, thoracic and mediastinal disorders1/200/21
ToothacheGastrointestinal disorders1/200/21
PyrexiaGeneral disorders1/200/21
Seasonal AllergyImmune system disorders1/200/21
Renal Failure AcuteRenal and urinary disorders1/200/21
DermatitisSkin and subcutaneous tissue disorders1/200/21

Baseline characteristics

Age, Continuous
Age, Continuous(Years)Cohort 1Cohort 2Total
Mean50 ± 12.748 ± 10.949 ± 11.7
Sex/Gender, Customized
Sex/Gender, Customized(Participants)Cohort 1Cohort 2Total
Male101
Female192140
Region of Enrollment
Region of Enrollment(Participants)Cohort 1Cohort 2Total
United States202141
08

Study locations

4 sites
  • Anaheim, California 92801, United States
  • DeLand, Florida 32720, United States
  • South Miami, Florida 33143, United States
  • Dallas, Texas 75231, United States
09

References and documents

Publications

  • Fleischmann R, Winkle P, Miner JN, Yan X, Hicks L, Valdez S, Hall J, Liu S, Shen Z, Gillen M, Hernandez-Illas M. Pharmacodynamic and pharmacokinetic effects and safety of verinurad in combination with allopurinol in adults with gout: a phase IIa, open-label study. RMD Open. 2018 Feb 8;4(1):e000584. doi: 10.1136/rmdopen-2017-000584. eCollection 2018. PubMed 29531784 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2015 to primary completion in Nov 2015, 3 months.

Results were first posted in Jan 2018, 2 years 2 months after primary completion.

Of 25 industry-sponsored phase 2 interventional studies under Gout, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 19. This study's 3 months is below that.

Counting every sponsor, half of 30 studies reached it within 14 months; a quarter within 7 and three quarters within 22.

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

Registered
Jul 13, 2015
First posted
Jul 15, 2015
StartActual
Jul 28, 2015
Primary completionActual
Nov 19, 2015
CompletionActual
Jun 2, 2016
Results first posted
Jan 23, 2018
Last update
Jan 23, 2018
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 Jan 23, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02498652
Lead sponsor
Ardea Biosciences, Inc.
Responsible party
Sponsor
First posted
Jul 15, 2015
Start date
Jul 28, 2015
Primary completion
Nov 19, 2015
Completion
Jun 2, 2016
Results posted
Jan 23, 2018
Last update
Jan 23, 2018

Study contacts

Jesse Hall, MD
study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Verinurad · Allopurinol

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