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RDEA3170 and Febuxostat Combination Study in Gout Subjects

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ClinicalTrials.gov Identifier: NCT02246673
Recruitment Status : Completed
First Posted : September 23, 2014
Results First Posted : July 27, 2017
Last Update Posted : July 27, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Gout Drug: RDEA3170 15 mg Drug: RDEA3170 10 mg Drug: RDEA3170 2.5 Drug: RDEA3170 5 mg Drug: Febuxostat 40 mg Drug: Febuxostat 80 mg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2014
Actual Primary Completion Date : July 2015
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gout
Drug Information available for: Febuxostat

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Serum Urate Maximum Percentage (%) Change (Emax, CB) [ Time Frame: 28 days ]
    Maximum observed percentage (%) change from baseline in serum urate concentrations.

  2. Urine Uric Acid % Change (0-24h) (Aeur, CB) [ Time Frame: 28 days ]
    Percentage (%) change from baseline in the amount of uric acid recovered in urine.

  3. Renal Clearance of Uric Acid % Change (0-24h) (CLur, CB) [ Time Frame: 28 days ]
    Percentage (%) change from baseline in renal clearance of uric acid.

  4. Fract. Excretion of Uric Acid % Change (0-24h) (FEUA, CB) [ Time Frame: 28 days ]
    Percentage (%) change from baseline in fractional excretion of uric acid.


Secondary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: Days 7 to 28 ]
    Cmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

  2. Time of Occurrence of Maximum Observed Concentration (Tmax) [ Time Frame: Days 7 to 28 ]
    Tmax of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

  3. Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) [ Time Frame: Days 7 to 28 ]
    AUC 0-24 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

  4. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) [ Time Frame: Days 7 to 28 ]
    AUC last of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

  5. Apparent Terminal Half-life (t1/2) [ Time Frame: Days 7 to 28 ]
    t1/2 of multiple-dose RDEA3170 administered in combination with febuxostat from plasma

  6. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 10 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246673


Locations
United States, California
Anaheim, California, United States, 92801
Glendale, California, United States, 91206
United States, Florida
South Miami, Florida, United States, 33143
United States, Kansas
Overland Park, Kansas, United States, 66211
Overland Park, Kansas, United States, 66212
United States, Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
Study Director: J. Hall Ardea Biosciences, Inc.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02246673     History of Changes
Other Study ID Numbers: RDEA3170-204
First Posted: September 23, 2014    Key Record Dates
Results First Posted: July 27, 2017
Last Update Posted: July 27, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Febuxostat
Gout Suppressants
Antirheumatic Agents