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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-12-31

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).

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Detailed Description

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Conditions

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Candidiasis, Vulvovaginal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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VT-1161 300mg QD

Group Type EXPERIMENTAL

VT-1161

Intervention Type DRUG

VT-1161 600mg QD

Group Type EXPERIMENTAL

VT-1161

Intervention Type DRUG

VT-1161 600mg BID

Group Type EXPERIMENTAL

VT-1161

Intervention Type DRUG

Fluconazole 150mg

Group Type ACTIVE_COMPARATOR

Fluconazole

Intervention Type DRUG

Interventions

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VT-1161

Intervention Type DRUG

Fluconazole

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No