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Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout

NCT00985127 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2012-01-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

placebo

administered daily for 21 days

DRUG

BCX4208

Administered daily for 21 days.

Sponsors & Collaborators

  • BioCryst Pharmaceuticals

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2010-09-30
Completion
2010-09-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00985127 on ClinicalTrials.gov