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Completed

NCT Number: NCT02317861

A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients

The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone and febuxostat administered alone in Japanese adult male subjects with gout or asymptomatic hyperuricemia.

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Key information

Conditions

Gout and Asymptomatic Hyperuricemia Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

20 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Research Site

Fukuoka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Screening serum uric acid level ≥ 8 mg/dL;
  • Body weight ≥ 50 kg and a body mass index (BMI) ≥ 18 and ≤ 40 kg/m2;
  • Free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion criteria

  • History or suspicion of kidney stones;
  • Diagnosis of benign prostatic hypertrophy (BPH) or neurogenic bladder or evidence of BPH/neurogenic bladder such as thin urinary stream or difficulty in urination;
  • An estimated creatinine clearance < 60 mL/min calculated by the Cockcroft-Gault formula;
  • QTcF interval (QT interval corrected for heart rate using Fridericia's formula) > 450 msec at Screening;
  • Receiving strong or moderate Cytochrome P450 (CYP) 3A inhibitors or p-glycoprotein inhibitors, or digoxin

Treatment and study plan

RDEA3170

Drug

Oral Treatment

Febuxostat

Drug

Oral Treatment

Benzbromarone

Drug

Oral Treatment

Primary outcomes

  1. Change in Serum uric acid level

    Time frame: baseline and day 7 on each treatment

    % change per treatment will be compared.

  2. Change in Urinary excretion of uric acid

    Time frame: baseline and day 7 on each treatment

    Timed urinary uric acid excretion per treatment will be compared

  3. Renal clearance of uric acid

    Time frame: baseline and day 7 on each treatment

    Renal clearance of uric acid will be calculated.

  4. Fractional excretion of uric acid

    Time frame: baseline and day 7 on each treatment

    Fractional excretion and renal clearance of uric acid will be calculated.

Secondary outcomes

  1. Maximum plasma concentration (Cmax)

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment

    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.

  2. Time to reach maximum concentration (tmax)

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment

    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.

  3. Area under the concentration-time curve (AUC)

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment

    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.

  4. Half life (t1/2)

    Time frame: 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 , 24 hours post-dose on each treatment

    To assess multiple-dose PK of RDEA3170 and febuxostat alone or in combination treatment.

  5. Incidence of adverse events

    Time frame: Day 1 and Day 7 on each treatment

    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170

  6. Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters

    Time frame: Day 1 and Day 8 on each treatment

    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170

  7. Changes in vital signs and physical examination findings

    Time frame: Day 1 and Day 8 on each treatment

    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170

  8. Incidence of adverse events

    Time frame: Day 42 of the study as follow up

    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170

  9. Changes in hematology, serum chemistry, coagulation, electrocardiogram and urinalysis parameters

    Time frame: Day 42 of the study as follow up

    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170

  10. Changes in vital signs and physical examination findings

    Time frame: Day 42 of the study as follow up

    To evaluate the safety and tolerability of febuxostat alone, RDEA3170 alone and RDEA3170 administered in combination of febuxostat and febuxostat in combination of RDEA3170

Other outcomes

  1. Change in Urinary pH

    Time frame: baseline and day 7 on each treatment

    To evaluate the relationship between the doses of uralyt and urinary pH under the administration of RDEA3170.

  2. Deoxyribonucleic acid polymorphism

    Time frame: Day 1 of the study as randomization

    To collect and store deoxyribonucleic acid (DNA) for future exploratory research.

  3. Change in Serum uric acid level

    Time frame: Baseline and day 7 on each treatment for cohort 6

    % change per treatment will be compared.

  4. Change in Urinary excretion of uric acid

    Time frame: Baseline and day 7 on each treatment for cohort 6

    Timed urinary uric acid excretion per treatment will be compared.

  5. Renal clearance of uric acid

    Time frame: Baseline and day 7 on each treatment for cohort 6

    Renal clearance of uric acid will be calculated.

  6. Fractional excretion of uric acid

    Time frame: Baseline and day 7 on each treatment for cohort 6

    Fractional excretion and renal clearance of uric acid will be calculated.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • Ardea Biosciences, Inc.

Registry information

Official study title

A Phase 2a, Randomized, Open-Label, Single-Site Study to Evaluate the Pharmacodynamic Effects and Safety of RDEA3170 Administered in Combination With Febuxostat Compared to RDEA3170 Administered Alone and Febuxostat Administered Alone, Respectively in Japanese Adult Male Subjects With Gout or Asymptomatic Hyperuricemia

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Dec 17, 2014
Registry last updated
Jun 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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