drugset / Trial / NCT00985127
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208. The second part is planned as a dose-escalation study, evaluating higher doses including 160 mg, 240 mg and 320 mg BCX-4208. The study's primary endpoint is the change in uric acid in the blood compared to baseline measurement prior to treatment, assessed on Day 22.
Timeline
- Start
- 2009-09
- Primary completion
- 2010-09
- Completion
- 2010-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ulodesine | Small molecule | 40 mg | — |
| Subject | Ulodesine | Small molecule | 80 mg | — |
| Subject | Ulodesine | Small molecule | 120 mg | — |
| Subject | Ulodesine | Small molecule | 160 mg | — |
| Subject | Ulodesine | Small molecule | 240 mg | — |
| Subject | Ulodesine | Small molecule | 320 mg | — |