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Completed

NCT Number: NCT03272425

Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.

To assess the bioequivalence between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fasted state based on the pharmacokinetic (PK) evaluation of lesinurad and allopurinol in healthy adult subjects.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CAEP - Centro Avançado de Estudos e Pesquisas Ltda.

Campinas, São Paulo, Brazil

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Body mass index ranging between 18.5 kg/m2 and 30 kg/m2.
  • Screening serum urate level is ≤ 7.0 mg/dL.

Exclusion criteria

  • Asian subject who has a positive test for the HLA-B*5801 allele.
  • History or current diagnosis of kidney stones.
  • Estimated creatinine clearance, as determined at Screening, of ≤ 80 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
  • Undergone major surgery within 3 months prior to Screening.
  • Donated blood within 4 weeks prior to Day 1 or experienced an event (other than blood donation) of significant blood loss (> 450 mL) within 12 weeks prior to Day 1 or has given a plasma donation within 4 weeks prior to Day 1.
  • Inadequate venous access or unsuitable veins for repeated venipuncture.
  • Received any strong or moderate enzyme-inducing drug or product within 2 months prior to Screening.

Treatment and study plan

lesinurad/allopurinol 200/300 FDC tablets

Drug

Test Drug

lesinurad 200 mg

Drug

Comparator 1

Allopurinol 300 MG

Drug

Comparator 2

Primary outcomes

  1. Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

    Time frame: Days 1, 8, 15 and 22

    Cmax is the maximum observed concentration of a drug after administration

  2. PK endpoints in terms of area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint (AUC last) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

    Time frame: Days 1, 8, 15 and 22

    AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint

  3. PK endpoints in terms of area under the plasma concentration time curve from and from zero to infinity (AUC 0-∞) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

    Time frame: Days 1, 8, 15 and 22

    AUC 0-∞ is a meausre of total concentration from time zero to infinity

  4. PK endpoints in terms of time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

    Time frame: Days 1, 8, 15 and 22

    Tmax is the time of occurrence of cmax

  5. PK endpoints in terms of apparent terminal half-life (t1/2) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

    Time frame: Days 1, 8, 15 and 22

    t1/2 is a measure of apparent terminal half-life

Secondary outcomes

  1. Incidence of Adverse Events in terms of changes in laboratory parameters

    Time frame: 26 days

  2. Incidence of Adverse Events in terms of electrocardiogram parameters

    Time frame: 26 days

  3. Incidence of Adverse Events in terms of vital signs

    Time frame: 26 days

  4. Incidence of Adverse Events in terms of physical examination findings

    Time frame: 26 days

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Randomized, Open-label, Replicate, Crossover, 4-period Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-dose Combination 200/300 mg Tablets From Ardea Biosciences, Inc. (Test Drug) Versus Lesinurad, 200 mg Tablet From AstraZeneca (Comparator 1) Coadministered With Zyloric®, Allopurinol 300 mg Tablet From Aspen Pharma Industria Farmaceutica Ltda. (Comparator 2) in Healthy Female and Male Adult Subjects, Under Fasting Conditions.

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Sep 5, 2017
Registry last updated
Nov 7, 2018

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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