Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Ardea Biosciences, Inc.
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.
Age
18–65
Sex
MALE
Healthy volunteers
Accepted
You may be eligible if
Body mass index ranging between 18 kg/m2 and 40 kg/m2.
Screening serum urate level is ≤ 7.0 mg/dL.
You may not be if
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.
