Clinical trial NCT03272425: Lesinurad/Allopurinol 200/300 Fixed-Dose Combination (FDC) Tablets Bioequivalence.
Official title: A Randomized, Open-label, Replicate, Crossover, 4-period Study to Assess the Bioequivalence of Lesinurad/Allopurinol Fixed-dose Combination 200/300 mg Tablets From Ardea Biosciences, Inc. (Test Drug) Versus Lesinurad, 200 mg Tablet From AstraZeneca (Comparator 1) Coadministered With Zyloric®, Allopurinol 300 mg Tablet From Aspen Pharma Industria Farmaceutica Ltda. (Comparator 2) in Healthy Female and Male Adult Subjects, Under Fasting Conditions.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gout
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2017-09-05
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Pharmacokinetics (PK) endpoints in terms of maximum observed concentration (Cmax) for lesinurad/allopurinol 200/300 FDC tablets relative to lesinurad and allopurinol monocomponent tablets
timeFrame: Days 1, 8, 15 and 22
measure: 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
timeFrame: Days 1, 8, 15 and 22
measure: 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
timeFrame: Days 1, 8, 15 and 22
measure: 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
timeFrame: Days 1, 8, 15 and 22
measure: 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
timeFrame: Days 1, 8, 15 and 22
Secondary outcomes:
measure: Incidence of Adverse Events in terms of changes in laboratory parameters
timeFrame: 26 days
measure: Incidence of Adverse Events in terms of electrocardiogram parameters
timeFrame: 26 days
measure: Incidence of Adverse Events in terms of vital signs
timeFrame: 26 days
measure: Incidence of Adverse Events in terms of physical examination findings
timeFrame: 26 days
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: CAEP - Centro Avançado de Estudos e Pesquisas Ltda.
state: Sao Paulo
Study officials:
affiliation: Ardea Biosciences, Inc.
name: N. Bhakta
role: STUDY_DIRECTOR
References: