drugset / Trial / NCT03253094
Dose-Finding Study of Oral Ibrexafungep (SCY-078) vs. Oral Fluconazole in Subjects With Acute Vulvovaginal Candidiasis
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This is a multicenter, randomized, double-blind, double-dummy, active-controlled, dose-finding study to compare the efficacy, safety and tolerability of oral SCY-078 versus oral fluconazole in adult female subjects 18 years and older with moderate to severe Acute Vulvovaginal Candidiasis (AVVC). Approximately 180 eligible subjects (30 subjects per treatment group) will be enrolled and randomized into the study.
Timeline
- Start
- 2017-08-01
- Primary completion
- 2018-05-04
- Completion
- 2018-05-04
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Fluconazole | Small molecule | 150 mg | Oral |
| Subject | Ibrexafungerp | Small molecule | 150 mg | Oral |
| Subject | Ibrexafungerp | Small molecule | 300 mg | Oral |
| Subject | Ibrexafungerp | Small molecule | 450 mg | Oral |
| Subject | Ibrexafungerp | Small molecule | 750 mg | Oral |