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Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence

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ClinicalTrials.gov Identifier: NCT02888054
Recruitment Status : Completed
First Posted : September 2, 2016
Last Update Posted : June 16, 2017
Sponsor:
Information provided by (Responsible Party):
Ardea Biosciences, Inc.

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Healthy Drug: lesinurad/allopurinol 200/300 FDC tablet Drug: lesinurad 200 mg Drug: allopurinol 300 mg Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : August 30, 2016
Actual Primary Completion Date : October 18, 2016
Actual Study Completion Date : February 1, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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)
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
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)
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
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)
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg
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)
Drug: lesinurad/allopurinol 200/300 FDC tablet
Drug: lesinurad 200 mg
Drug: allopurinol 300 mg



Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02888054


Locations
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United States, Texas
Austin, Texas, United States, 78744
Sponsors and Collaborators
Ardea Biosciences, Inc.
Investigators
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Study Director: N. Bhakta Ardea Biosciences, Inc.

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Responsible Party: Ardea Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT02888054     History of Changes
Other Study ID Numbers: RDEA594-503
First Posted: September 2, 2016    Key Record Dates
Last Update Posted: June 16, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
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Allopurinol
Lesinurad
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Gout Suppressants
Antirheumatic Agents
Free Radical Scavengers
Antioxidants
Protective Agents
Physiological Effects of Drugs
Uricosuric Agents
Renal Agents