A Randomized, Double-Blind, Multi-center, Placebo-Controlled, Combination Study to Evaluate the Urate-Lowering Activity, Safety, and Potential Pharmacokinetic Interaction of Oral BCX4208 and Allopurinol Administered in Subjects With Gout

This study is a Phase 2, randomized, double-blind, multi-center, placebo-controlled study to evaluate efficacy and safety of BCX4208 alone and in combination with allopurinol in approximately 80 subjects with gout. The study is a factorial design, evaluating doses of BCX4208 previously found to be safe and well-tolerated in healthy subjects and subjects with psoriasis and gout. Doses of allopurinol are according to package insert recommendations.

Approximately 80 subjects will be randomized equally to one of 16 treatment groups.

The study will consist of 3 periods: the Screening Period, the Treatment Period, and the Follow-Up Period. The Screening period will be conducted within Day -30 to Day -1, as long as all inclusion and exclusion criteria are satisfied (see Section 8). For subjects receiving urate-lowering therapy; these subjects must discontinue the urate-lowering therapy by Day -14 to assure a washout period of at least 14 days before entering the Treatment Period. Some Screening procedures such as a recording of medical history and clinical laboratory tests performed at Screening only may be performed at any time during the Screening Period (Day -30 to Day -1). Other Screening procedures must be performed within the 7 days prior to the first dose of study drug (i.e., from Day -7 to Day -1); these include: physical examination, height, weight, clinical chemistry (including baseline and qualifying sUA), hematology, and urinalysis evaluations, CD4+, CD8+, CD20+, and CD56+ lymphocyte counts, a serum pregnancy test in females of child-bearing potential, 12-lead ECG, and vital signs assessments. An otherwise qualified subject may have up to 2 repeated determinations of sUA and/or lymphocyte subsets assayed to meet the entry criteria for this study, as long as the qualifying sUA and lymphocyte subsets assays occur 7 or fewer days prior to the first dose of study drug. These assessments will constitute the Baseline assessments for the purpose of comparisons with these same assessments post-dose.

Gout flare prophylaxis with colchicine or naproxen is required to be started prior to the first dose of study drug. Colchicine 0.6 mg once a day will begin at least 7 days prior to Day 1, or naproxen 250 mg twice daily will be started at least 48 hours prior to Day 1. For subjects who discontinue urate-lowering therapy, the required gout flare prophylaxis will begin at or before the cessation of the urate-lowering therapy.

A recording of concomitant medications and AEs will take place from the time of the signing of the Informed Consent Form (ICF) and throughout the duration of the study.