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RDEA3170 Monotherapy in Subjects With Gout

Sponsor
Ardea Biosciences, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01927198
Collaborator
(none)
172
Enrollment
50
Locations
4
Arms
11
Duration (Months)
3.4
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.

Condition or Disease Intervention/Treatment Phase
  • Drug: Placebo
  • Drug: RDEA3170 5 mg
  • Drug: RDEA3170 10 mg
  • Drug: RDEA3170 12.5 mg
 Phase 2

Detailed Description

This monotherapy study is the initial Phase 2 study for RDEA3170 and is designed to compare the safety and efficacy of multiple dose levels of RDEA3170 with placebo when given for up to 24 weeks to subjects with gout. The placebo control for RDEA3170 is included in this study to minimize bias in study assessments and monitoring. Further, to accomplish the goal of understanding the safety profile of RDEA3170, it is important to compare RDEA3170 monotherapy with placebo for at least 24 weeks.

Study Design

Study Type:
Interventional
Actual Enrollment :
172 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout
Study Start Date :
Aug 1, 2013
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Jul 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: RDEA3170 5 mg qd

No titration.

Drug: RDEA3170 5 mg
Experimental: RDEA3170 10 mg qd

Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.

Drug: RDEA3170 10 mg
Experimental: RDEA3170 12.5 mg qd

Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.

Drug: RDEA3170 12.5 mg
Placebo Comparator: Placebo

Placebo group

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. Efficacy of RDEA3170 monotherapy at Week 12 [Week 12]

    Percent change from baseline in serum urate levels at Week 12.

Secondary Outcome Measures

  1. Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms [8 months]

    Safety assessments include adverse event (AE) recording, gout flare recording, clinical safety laboratory tests (eg, hematology, serum chemistry, and urinalysis), physical examinations, vital sign measurements, and ECGs.

  2. Efficacy of RDEA3170 monotherapy at Week 24 [Week 24]

    Percent change from baseline in serum urate levels at each visit. Proportion of subjects with a serum urate level < 6.0 and < 5.0 mg/dL at each visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 70 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Subject meets the diagnosis of gout per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.

  • Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.

  • Subject has a body mass index < 40 kg/m2.

Exclusion Criteria:

  • Subject is pregnant or breastfeeding. Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz [150 mL] of wine, 12 oz [360 mL] of beer, or 1.5 oz [45 mL] of hard liquor).

  • Subject has a history or suspicion of kidney stones.

  • Subject has a history or suspicion of drug abuse within the past 5 years.

  • Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.

  • Subject has a known or suspected human immunodeficiency virus infection.

  • Subject has a positive test for active hepatitis B or hepatitis C infection.

  • Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.

  • Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.

  • Subject has a QT interval corrected for heart rate according to Fridericia's formula > 450 msec during the Screening Period, confirmed by a repeat assessment.

  • Subject has uncontrolled hypertension.

  • Subject has an estimated creatinine clearance < 60 mL/min.

  • Subject has an alkaline phosphatase > 2.0 x upper limit of normal during the Screening Period.

  • Subject has active liver disease or impaired hepatic function.

  • Subject is receiving chronic treatment with more than 325 mg salicylates per day.

  • Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.

  • Subject is unable to take colchicine for gout flare prophylaxis.

  • Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.

  • Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.

  • Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.

  • Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Birmingham Alabama United States 35235
2 Gulf Shores Alabama United States 36542
3 Mobile Alabama United States 36608
4 Glendale Arizona United States 85308
5 Peoria Arizona United States 85381
6 Tucson Arizona United States 85704
7 Anaheim California United States 92805
8 Gold River California United States 95670
9 Irvine California United States 92618
10 San Leandro California United States 94578
11 San Ramon California United States 94582
12 Colorado Springs Colorado United States 80918
13 Denver Colorado United States 80220
14 Jacksonville Florida United States 32205
15 Pembroke Pines Florida United States 33027
16 Tampa Florida United States 33606
17 Winter Haven Florida United States 33880
18 Dunwoody Georgia United States 30338
19 Honolulu Hawaii United States 96814
20 Meridian Idaho United States 83646
21 Gurnee Illinois United States 60031
22 Elizabethtown Kentucky United States 42701
23 Lexington Kentucky United States 40503
24 Metairie Louisiana United States 70006
25 Jackson Mississippi United States 39202
26 Reno Nevada United States 89502
27 New York New York United States 10016
28 Charlotte North Carolina United States 28210
29 Hickory North Carolina United States 28602
30 Shelby North Carolina United States 28150
31 Shelby North Carolina United States 28152
32 Wilmington North Carolina United States 28401
33 Winston-Salem North Carolina United States 27103
34 Fargo North Dakota United States 58103
35 Cincinnati Ohio United States 45224
36 Perrysburgh Ohio United States 43551
37 Perrysburg Ohio United States 43551
38 Willoughby Hills Ohio United States 44904
39 Altoona Pennsylvania United States 16602
40 Greenville South Carolina United States 29615
41 Greer South Carolina United States 29651
42 Mount Pleasant South Carolina United States 29464
43 Rock Hill South Carolina United States 29732
44 Spartanburg South Carolina United States 29303
45 Spring Hill Tennessee United States 37174
46 Houston Texas United States 77098
47 Bountiful Utah United States 84010
48 Midlothian Virginia United States 23114
49 Richmond Virginia United States 23219
50 Virginia Beach Virginia United States 23462

Sponsors and Collaborators

  • Ardea Biosciences, Inc.

Investigators

  • Study Director: J. Hall, MD, Ardea Biosciences, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier:
NCT01927198
Other Study ID Numbers:
  • RDEA3170-201
First Posted:
Aug 22, 2013
Last Update Posted:
Jul 1, 2015
Last Verified:
Jun 1, 2015
Additional relevant MeSH terms:
Gout
Verinurad

Study Results

No Results Posted as of Jul 1, 2015