A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/3/2018 |
| Start Date: | August 2013 |
| End Date: | December 2014 |
A Phase 2A, Randomized, Double-Blind, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets Compared to Fluconazole in the Treatment of Patients With Moderate to Severe Acute Vulvovaginal Candidiasis
The purpose of this study is to determine if the novel oral agent VT-1161 is safe and
effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast
infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal
growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the
fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole
antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this
results in many of the side effects associated with the azole antifungals. The safety profile
of the class similarly limits use in chronic treatment of non-life-threatening fungal
infections. VT-1161 has been design to be safer and more active against the fungal species
typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
effective in treating patients with acute vulvovaginal candidiasis (also referred to as yeast
infection). VT-1161 has been designed to inhibit CYP51, an enzyme essential for fungal
growth. Inhibition of CYP51 results in the accumulation of chemicals know to be toxic to the
fungus. CYP51 is the molecular target of the class of drugs referred to as 'azole
antifungals'. All currently approved azole drugs have poor selectivity for CYP51 and this
results in many of the side effects associated with the azole antifungals. The safety profile
of the class similarly limits use in chronic treatment of non-life-threatening fungal
infections. VT-1161 has been design to be safer and more active against the fungal species
typically responsible for vaginal yeast infections (i.e. vulvovaginal candidiasis).
Key Inclusion Criteria:
- Females ≥18 and <65 years
- Clinical diagnosis of symptomatic acute VVC
- Positive KOH .At least one vulvovaginal sign (vulvovaginal erythema, edema, or
excoriation).
- At least one vulvovaginal symptom (vulvovaginal itching, burning, or irritation)
- A minimum composite vulvovaginal signs and symptoms score of ≥6
- must be be able to swallow capsules
Exclusion Criteria:
- Evidence of major organ system disease
- History of cervical cancer
- History of diabetes mellitus
- Pregnant
- Recent use of systemic antifungal drugs or systemic antimicrobial therapy for any
reason
- Recent use of drugs to treat vaginal infections
- Recent use of immunosuppressive therapies
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SUNY Downstate Medical Center Formally known as The State University of New York Health Science...
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