Lesinurad/Allopurinol 200/300 FDC Tablets Bioavailability

Ardea Biosciences, Inc.116 enrolled

Overview

This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.

The study comprises 2 parts. Part 1 will assess the relative BA of lesinurad/allopurinol FDC and monocomponents in fasted subjects. Part 2 will assess the effect of food on the PK of FDC tablets.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

116

Conditions

Healthy

Interventions

lesinurad/allopurinol 200/300 FDC tabletsDRUG

lesinurad 200 mgDRUG

allopurinol 300 mgDRUG

lesinurad/allopurinol 200/200 FDC tablets

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Body mass index ranging between 18 kg/m2 and 40 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.

Locations (1)

Unnamed facility

Austin, Texas, United States

Outcomes

Primary Outcomes

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

Cmax is the maximum observed concentration of a drug after administration

Time frame: Days 1 and Day 8

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

Tmax is the time of occurrence of cmax

Time frame: Day 1 and Day 8

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 and 200/200 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: Day 1 and Day 8

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 and 200/200 FDC tablets relative to lesinurad and allopurinol monocomponent tablets

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

Time frame: Day 1 and Day 8

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

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

Time frame: Day 1 and Day 8

Secondary Outcomes

Incidence of Adverse Events in terms of changes in laboratory parameters

Data from ClinicalTrials.gov

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