Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 18, 2016

Detailed Description

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

Interventions

  • Drug: lesinurad/allopurinol 200/300 FDC tablet
  • Drug: lesinurad 200 mg
  • Drug: allopurinol 300 mg

Arms, Groups and Cohorts

  • Experimental: Sequence ABBA
    • Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A)
  • Experimental: Sequence BABA
    • Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 22: lesinurad/allopurinol 200/300 FDC tablet (Sequence A)
  • Experimental: Sequence ABAB
    • Day 1: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 8: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B)
  • Experimental: Sequence BAAB
    • Day 1: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B) Day 8: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 15: lesinurad/allopurinol 200/300 FDC tablet (Sequence A) Day 22: coadministered lesinurad 200 mg + allopurinol 300 mg tablets (Sequence B)

Clinical Trial Outcome Measures

Primary Measures

  • 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
  • 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
  • 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
  • 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
  • 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 Measures

  • Incidence of Adverse Events in terms of changes in laboratory parameters
    • Time Frame: 8 weeks
  • Incidence of Adverse Events in terms of electrocardiogram parameters
    • Time Frame: 8 weeks
  • Incidence of Adverse Events in terms of vital signs
    • Time Frame: 8 weeks

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Ardea Biosciences, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • N. Bhakta, Study Director, Ardea Biosciences, Inc.

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