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Completed

NCT Number: NCT02888054

Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

This study will assess the bioequivalence (BE) of Lesinurad/Allopurinol Fixed-Dose Combination (FDC) Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

Completed

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Key information

Conditions

Healthy

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Austin, Texas, 78744, United States

About this study

The study will assess the BE between lesinurad/allopurinol 200/300 FDC tablets and coadministered lesinurad and allopurinol tablets in the fed state.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject has a body mass index ranging between 18 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 suspicion of kidney stones.
  • Estimated creatinine clearance, as determined at Screening, of < 90 mL/min calculated by the Cockcroft-Gault formula using ideal body weight.
  • Undergone major surgery within 3 months prior to Screening.
  • Donated blood or experienced significant blood loss (> 450 mL) within 12 weeks prior to Day 1or 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 tablet

Drug

lesinurad 200 mg

Drug

Allopurinol 300 MG

Drug

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 coadministered 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 time of occurrence of maximum observed concentration (tmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol coadministered monocomponent tablets

    Time frame: Days 1, 8, 15, and 22

    Tmax is the time of occurrence of cmax

  3. PK endpoints in terms of area under 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 coadministered monocomponent tablets

    Time frame: Days 1, 8, 15, and 22

    AUC last is a measure of total plasma concentration from time zero to the last measurable concentration

  4. 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 coadministered monocomponent tablets

    Time frame: Days 1, 8, 15, and 22

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

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

    Time frame: Days 1, 8, 15, 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: 8 weeks

  2. Incidence of Adverse Events in terms of electrocardiogram parameters

    Time frame: 8 weeks

  3. Incidence of Adverse Events in terms of vital signs

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Ardea Biosciences, Inc.

Industry

Registry information

Official study title

A Phase 1, Randomized, Open-Label, Replicate, Crossover Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-Dose Combination Tablets and Coadministered Lesinurad and Allopurinol Tablets in Fed Healthy Adult Subjects

Important dates

Study start
2016
Primary completion
2016
Study completion
2017
First posted
Sep 2, 2016
Registry last updated
Jun 16, 2017

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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