drugset / Trial / NCT00614666
Safety and PK of Nikkomycin Z for Coccidioides Pneumonia Treatment
Phase 1/2
Terminated
6 enrolled
University of Arizona
FDA Office of Orphan Products Development · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The purpose of this study is to determine if nikkomycin Z is safe when administered at different dose levels for 14 days. The study will also determine blood levels and urinary excretion of nikkomycin Z in relation to dose administered. Patients with mild forms of Valley Fever pneumonia will be eligible to participate and will be allocated to receive treatment with nikkomycin Z (various doses) or a placebo. A secondary goal of this study is to evaluate the effectiveness and dose response of nikkomycin Z in an exploratory analysis.
Timeline
- Start
- 2007-09
- Primary completion
- 2009-09
- Completion
- 2009-09
Outcome
Outcome not reported
Stopped (Enrollment): “Recruitment challenges and lack of funding caused an early end to this study”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NIKKOMYCIN | Small molecule | 50 mg | — |
| Subject | NIKKOMYCIN | Small molecule | 250 mg | — |
| Subject | NIKKOMYCIN | Small molecule | 500 mg | — |
| Subject | NIKKOMYCIN | Small molecule | 750 mg | — |