Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

An Open-Label, Non-Comparative Study of FK463 in the Treatment of Candidemia or Invasive Candidiasis

The purpose of the study is to evaluate the safety and efficacy of FK463 in the treatment of patients with confirmed candidemia or invasive candidiasis.

This will be an open-label, non-comparative study of intravenous FK463. Enrollment will include at least 100 patients evaluable for efficacy.

Inclusion Criteria

• Has Candidemia or invasive candidiasis documented by typical clinical signs and symptoms and confirmed by fungal culture or histologic confirmation

Exclusion Criteria

• Has abnormal liver test parameters, e.g., AST or ALT > 10 times upper limit of normal
• Has life expectancy judged to be less than 5 days
• De novo patients who have received a systemic antifungal agent for the treatment of this episode of candidemia or invasive candidiasis for more than 48 hours prior to the first dose of FK463; or efficacy failure patients who have received =< 5 days of prior systemic antifungal therapy for the treatment of this episode of candidemia or invasive candidiasis
• Require treatment with topical or systemic antifungal agents for conditions other than candidemia or invasive candidiasis