A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Acute Vaginal Candidiasis (Yeast Infection)

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Candidiasis, Vulvovaginal

Intervention / Treatment
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* Drug: VT-1161
* Drug: Fluconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VT-1161 300mg QD<br> | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 600mg QD<br> | Drug: VT-1161<br> <br> |
| Experimental: VT-1161 600mg BID<br> | Drug: VT-1161<br> <br> |
| Active Comparator: Fluconazole 150mg<br> | Drug: Fluconazole<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population | For this trial, therapeutic cure was defined as mycological AND clinical cure. Mycological cure was defined as a negative fungal culture for Candida species. Clinical cure was defined as all of the following: complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis; any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis; no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject. | 4 weeks |