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RDEA3170 and Allopurinol Combination Study in Gout Subjects

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ClinicalTrials.gov Identifier: NCT02279641
Recruitment Status : Completed
First Posted : October 31, 2014
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
This is a Phase 1b, randomized, open-label, drug-drug interaction study in adult male subjects with gout. It is designed to assess the pharmacokinetics (PK) and pharmacodynamics (PD) of RDEA3170 or allopurinol alone and in combination in the fed state.

Condition or disease Intervention/treatment Phase
Gout Drug: RDEA3170 10 mg Drug: allopurinol 300 mg Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: A Phase 1b, Randomized, Open-label Study to Evaluate the Potential Pharmacokinetic and Pharmacodynamic Interactions Between RDEA3170 and Allopurinol in Adult Male Subjects With Gout
Actual Study Start Date : November 1, 2014
Actual Primary Completion Date : April 6, 2015
Actual Study Completion Date : September 11, 2015

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Experimental: Sequence A
RDEA3170 qd (once daily), RDEA3170 + allopurinol qd, allopurinol qd
Drug: RDEA3170 10 mg
Drug: allopurinol 300 mg
Experimental: Sequence B
allopurinol qd, RDEA3170 + allopurinol qd, RDEA3170 qd
Drug: RDEA3170 10 mg
Drug: allopurinol 300 mg



Primary Outcome Measures :
  1. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 22 days ]
    Cmax of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

  2. Time of Occurrence of Maximum Observed Concentration (Tmax) [ Time Frame: 22 days ]
    Tmax of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

  3. Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) [ Time Frame: 22 days ]
    AUC 0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

  4. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) [ Time Frame: 22 days ]
    AUC last of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

  5. Apparent Terminal Half-life (t1/2) [ Time Frame: 22 days ]
    t1/2 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

  6. Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24) [ Time Frame: 22 days ]
    Ae0-24 of Allopurinol/Oxypurinol Alone and In Combination with RDEA3170

  7. Renal Clearance of the Drug From Time Zero up to 24 Hours Postdose (CRL0-24) [ Time Frame: 22 days ]
    CLR0-24 of Allopurinol/Oxypurinol and RDEA3170 Alone and In Combination

  8. Pharmacodynamics (PD) Profile of Uric Acid From Serum and Urine [ Time Frame: 22 days ]
  9. Maximum Observed Plasma Concentration (Cmax) [ Time Frame: 22 days ]
    Cmax of RDEA3170 Alone and In Combination with Allopurinol

  10. Area Under the Concentration-time Curve From Time Zero up to 24 Hours Postdose (AUC 0-24) [ Time Frame: 22 days ]
    AUC 0-24 of RDEA3170 Alone and In Combination with Allopurinol

  11. Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Sampling Timepoint (AUC Last) [ Time Frame: 22 days ]
    AUC last of RDEA3170 Alone and In Combination with Allopurinol

  12. Amount Excreted in Urine as Unchanged Drug or Metabolite (Ae0-24) [ Time Frame: 22 days ]
    Ae0-24 of RDEA3170 Alone and In Combination with Allopurinol


Secondary Outcome Measures :
  1. Incidence of Treatment-Emergent Adverse Events [ Time Frame: 22 days ]


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

Inclusion Criteria:

  • 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 and ≤ 10 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 an estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula using ideal body weight at Screening prior to Day -2.
  • Subject is on unstable doses of chronic medications. Subjects taking medications for chronic medical conditions must be on stable doses during the course of the study, including the Screening period. Dose adjustments are allowed if deemed medically necessary by the investigator and following discussion with the medical monitor
  • Chronic and stable doses of losartan, fenofibrate, guaifenesin, and sodium-glucose linked transporter-2 inhibitors are permitted if the dose is 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.

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): NCT02279641


Locations
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United States, Kansas
Overland Park, Kansas, United States, 66212
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: J. Hall, MD Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02279641     History of Changes
Other Study ID Numbers: RDEA3170-107
First Posted: October 31, 2014    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Gout
Gout Suppressants
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Allopurinol
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs