Healthy
Conditions
Brief summary
This study will assess relative bioavailability of lesinurad/allopurinol fixed dose combination (FDC), its individual components and the effect of food.
Detailed description
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.
Interventions
DRUGlesinurad 200 mg
DRUGlesinurad/allopurinol 200/200 FDC tablets
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 1 and Day 8 | t1/2 is a measure of apparent terminal half-life |
| 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 | Days 1 and Day 8 | Cmax is the maximum observed concentration of a drug after administration |
| 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 | Day 1 and Day 8 | Tmax is the time of occurrence of cmax |
| 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 | Day 1 and Day 8 | AUC last is the area under the plasma concentration time curve from zero to the last quantifiable sampling timepoint |
| 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 | Day 1 and Day 8 | AUC 0-∞ is a meausre of total concentration from time zero to infinity |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events in terms of electrocardiogram parameters | 6 weeks |
| Incidence of Adverse Events in terms of vital signs | 6 weeks |
| Incidence of Adverse Events in terms of physical examination findings | 6 weeks |
| Incidence of Adverse Events in terms of changes in laboratory parameters | 6 weeks |
Countries
United States
Outcome results
None listed