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Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02498652
Recruitment Status : Completed
First Posted : July 15, 2015
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Gout Drug: RDEA3170 2.5 mg Drug: allopurinol 300 mg Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 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 Allopurinol Compared With Allopurinol Administered Alone in Adult Subjects With Gout
Actual Study Start Date : July 28, 2015
Actual Primary Completion Date : November 19, 2015
Actual Study Completion Date : June 2, 2016

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
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

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).


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

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).


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


Outcome Measures
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Primary Outcome Measures :
  1. Cohort 1 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

  2. Cohort 1 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

  3. Cohort 1 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

  4. Cohort 1 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 1)

  5. Cohort 2 - Maximum Percentage (%) Change in Serum Urate of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (Emax, CB (%)) [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

  6. Cohort 2 - Concentration of Serum Urate at 24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol. [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

  7. Cohort 2 - Renal Xanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeXO, CB (%)) [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)

  8. Cohort 2 - Renal Hypoxanthine Excretion at 0-24hr of Multiple-dose RDEA3170 Administered in Combination With Allopurinol (AeHXO, CB (%)) [ Time Frame: Screening, Days -1 , 1, 7, 14, 21, 28, and 35 (Pre-dose and Post-dose) ]
    Pharmacodynamics (PD) profile of multiple-dose RDEA3170 administered in combination with allopurinol (Cohort 2)


Secondary Outcome Measures :
  1. Maximum Observed Concentration (Cmax) [ Time Frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) ]
    Cmax of Allopurinol alone or in combination with RDEA3170

  2. Time of Occurrence of Maximum Observed Concentration (Tmax) [ Time Frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) ]
    Tmax of Allopurinol alone or in combination with RDEA3170

  3. Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) [ Time Frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) ]
    AUC 0-24 of Allopurinol alone or in combination with RDEA3170

  4. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) [ Time Frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) ]
    AUC last of Allopurinol alone or in combination with RDEA3170

  5. Apparent Terminal Half-life (t1/2) [ Time Frame: Day 7, 14, 21, 28 and 35 (predose through 24 hours postdose) ]
    t1/2 of Allopurinol alone or in combination with RDEA3170

  6. Number of Participants With Treatment-Emergent Adverse Events [ Time Frame: 11 weeks ]

Eligibility Criteria
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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:

  • Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent 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 body mass index ≥ 18 and ≤ 45 kg/m2.
  • Subject has a Screening serum urate level ≥ 8 mg/dL.
  • Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

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, 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.
  • Subject has Screening laboratory parameters that are outside the normal limits and are considered clinically significant by the Investigator.
  • Subject has an estimated creatinine clearance < 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.
Contacts and Locations
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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): NCT02498652


Locations
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United States, California
Anaheim, California, United States, 92801
United States, Florida
DeLand, Florida, United States, 32720
South Miami, Florida, United States, 33143
United States, Texas
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: Jesse Hall, MD Ardea Biosciences, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02498652    
Other Study ID Numbers: RDEA3170-206
First Posted: July 15, 2015    Key Record Dates
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018
Last Verified: December 2017
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
 Verinurad
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs