Candidiasis, Vulvovaginal
Conditions
Brief summary
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).
Interventions
DRUGVT-1161
DRUGFluconazole
Sponsors
Viamet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| VT-1161 300mg QD | 14 |
| VT-1161 600mg QD | 12 |
| VT-1161 600mg BID | 14 |
| Fluconazole 150mg | 15 |
| Total | 55 |
Baseline characteristics
| Characteristic | VT-1161 300mg QD | VT-1161 600mg QD | VT-1161 600mg BID | Fluconazole 150mg | Total |
|---|---|---|---|---|---|
| Age, Continuous | 34.4 years STANDARD_DEVIATION 12.01 | 38.2 years STANDARD_DEVIATION 11.77 | 27.6 years STANDARD_DEVIATION 7.37 | 31.3 years STANDARD_DEVIATION 8.22 | 32.7 years STANDARD_DEVIATION 10.4 |
| Sex: Female, Male Female | 14 Participants | 12 Participants | 14 Participants | 15 Participants | 55 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 14 | 6 / 12 | 3 / 14 | 10 / 15 |
| serious Total, serious adverse events | 0 / 14 | 0 / 12 | 0 / 14 | 0 / 15 |
Outcome results
Primary
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: 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.
Time frame: 4 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| VT-1161 300mg QD | Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population | 9 Participants |
| VT-1161 600mg QD | Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population | 9 Participants |
| VT-1161 600mg BID | Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population | 11 Participants |
| Fluconazole 150mg | Percentage of Subjects With Therapeutic Cure at 28 Days for All-Analysis Population | 10 Participants |