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CompletedNCT03272425Updated Nov 7, 2018

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

A Phase 1 interventional study of lesinurad/allopurinol 200/300 FDC tablets and lesinurad 200 mg in Gout, sponsored by Ardea Biosciences, Inc.. Completed at 1 site in Brazil. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-11-07.

Sponsored by Ardea Biosciences, Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Gout
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    Sequence ABBA

    Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

    Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg

  • Experimental
    Sequence BABA

    Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

    Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg

  • Experimental
    Sequence ABAB

    Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

    Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg

  • Experimental
    Sequence BAAB

    Treatment A: Lesinurad/Allopurinol FDC Tablets - 200/300 mg (test product); Treatment B: lesinurad, tablets, 200 mg + Zyloric®, allopurinol, tablet, 300 mg (comparator 1 + comparator 2).

    Drug: lesinurad/allopurinol 200/300 FDC tablets · Drug: lesinurad 200 mg · Drug: allopurinol 300 mg

Interventions

  • Druglesinurad/allopurinol 200/300 FDC tablets

    Test Drug

  • Druglesinurad 200 mg

    Comparator 1

  • Drugallopurinol 300 mg

    Comparator 2

05

What researchers measure

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

    Cmax is the maximum observed concentration of a drug after administration

    Time frame: Days 1, 8, 15 and 22

  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

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

    Time frame: Days 1, 8, 15 and 22

  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

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

    Time frame: Days 1, 8, 15 and 22

  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

    Tmax is the time of occurrence of cmax

    Time frame: Days 1, 8, 15 and 22

  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

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

    Time frame: Days 1, 8, 15 and 22

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

06

Study locations

1 site
  • CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
    Campinas, Sao Paulo, Brazil
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03272425
Lead sponsor
Ardea Biosciences, Inc.
Responsible party
Sponsor
First posted
Sep 5, 2017
Start date
Aug 14, 2017
Primary completion
Oct 4, 2017
Completion
Oct 4, 2017
Last update
Nov 7, 2018

Study contacts

N. Bhakta
study director · Ardea Biosciences, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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