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

July 5, 2018 updated by: Viamet

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Lake Worth, Florida, United States, 33461
        • Altus Research
      • North Miami, Florida, United States, 33161
        • Healthcare Clinical Data, Inc
    • New York
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
    • North Carolina
      • Raleigh, North Carolina, United States, 27607
        • Lyndhurst Clinical Research
      • Winston-Salem, North Carolina, United States, 27103
        • Lyndhurst Clinical Research
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19102
        • Drexel Vaginitis Center
    • Texas
      • Irving, Texas, United States, 75062
        • Brownstone Clinical Trials, LLC
    • Washington
      • Seattle, Washington, United States, 98104
        • Harborview ID Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population
Time Frame: 4 weeks

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:

  1. complete resolution of signs and symptoms pertaining to vulvovaginal candidiasis;
  2. any new sign or symptom observed at 28 days determined by investigator to not be related to vulvovaginal candidiasis;
  3. no use of any other antifungal drug therapy for treatment of vulvovaginal irritation and/or pruritus by subject.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Viamet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

June 17, 2013

First Submitted That Met QC Criteria

July 2, 2013

First Posted (Estimate)

July 3, 2013

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 5, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VMT-VT-1161-CL-004

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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