Clinical trial NCT02888054: Lesinurad/Allopurinol 200/300 FDC Tablets Bioequivalence
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2016-09-02
Enrollment: 28
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: 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

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.

Eligibility 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

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 coadministered 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 coadministered monocomponent tablets
timeFrame: Days 1, 8, 15, and 22
measure: 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
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 coadministered 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 coadministered monocomponent tablets
timeFrame: Days 1, 8, 15, 22
Secondary outcomes:
measure: Incidence of Adverse Events in terms of changes in laboratory parameters
timeFrame: 8 weeks
measure: Incidence of Adverse Events in terms of electrocardiogram parameters
timeFrame: 8 weeks
measure: Incidence of Adverse Events in terms of vital signs
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Ardea Biosciences, Inc.
name: N. Bhakta
role: STUDY_DIRECTOR
References: