Healthy
Conditions
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.
Interventions
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Days 1, 8, 15, 22 | t1/2 is a measure of apparent terminal half-life |
| 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 | Days 1, 8, 15, and 22 | Tmax is the time of occurrence of cmax |
| 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 | Days 1, 8, 15, and 22 | AUC last is a measure of total plasma concentration from time zero to the last measurable concentration |
| 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 | Days 1, 8, 15, and 22 | AUC 0-∞ is a measure of total concentration from time zero to infinity |
| 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 | Days 1, 8, 15, and 22 | Cmax is the maximum observed concentration of a drug after administration |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events in terms of changes in laboratory parameters | 8 weeks |
| Incidence of Adverse Events in terms of electrocardiogram parameters | 8 weeks |
| Incidence of Adverse Events in terms of vital signs | 8 weeks |
Countries
United States
Outcome results
None listed