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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT-1161 300mg QD | Experimental |
| |
| VT-1161 600mg QD | Experimental |
| |
| VT-1161 600mg BID | Experimental |
| |
| Fluconazole 150mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT-1161 | Drug |
| ||
| Fluconazole |
| 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:
| 4 weeks |
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Key Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Altus Research | Lake Worth | Florida | 33461 | United States | ||
| Healthcare Clinical Data, Inc |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36396498 | Derived | Vanreppelen G, Nysten J, Baldewijns S, Sillen M, Donders G, Van Dijck P. Oteseconazole (VIVOJA) for prevention of recurrent vulvovaginal candidiasis. Trends Pharmacol Sci. 2023 Jan;44(1):64-65. doi: 10.1016/j.tips.2022.10.004. Epub 2022 Nov 14. No abstract available. | |
| 32818963 | Derived | Brand SR, Sobel JD, Nyirjesy P, Ghannoum MA, Schotzinger RJ, Degenhardt TP. A Randomized Phase 2 Study of VT-1161 for the Treatment of Acute Vulvovaginal Candidiasis. Clin Infect Dis. 2021 Oct 5;73(7):e1518-e1524. doi: 10.1093/cid/ciaa1204. |
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| ID | Title | Description |
|---|---|---|
| FG000 | VT-1161 300mg QD | VT-1161 300mg once daily for 3 days |
| FG001 | VT-1161 600mg QD | VT-1161 600mg once daily for 3 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| North Miami |
| Florida |
| 33161 |
| United States |
| SUNY Downstate Medical Center | Brooklyn | New York | 11203 | United States |
| Lyndhurst Clinical Research | Raleigh | North Carolina | 27607 | United States |
| Lyndhurst Clinical Research | Winston-Salem | North Carolina | 27103 | United States |
| Drexel Vaginitis Center | Philadelphia | Pennsylvania | 19102 | United States |
| Brownstone Clinical Trials, LLC | Irving | Texas | 75062 | United States |
| Harborview ID Research Clinic | Seattle | Washington | 98104 | United States |
| FG002 | VT-1161 600mg BID | VT-1161 600mg twice daily for 3 days |
| FG003 | Fluconazole 150mg | Single dose of fluconazole 150mg |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VT-1161 300mg QD | |
| BG001 | VT-1161 600mg QD | |
| BG002 | VT-1161 600mg BID | |
| BG003 | Fluconazole 150mg | |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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:
| Posted | Count of Participants | Participants | 4 weeks |
|
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | VT-1161 300mg QD | 0 | 14 | 10 | 14 | |||
| EG001 | VT-1161 600mg QD | 0 | 12 | 6 | 12 | |||
| EG002 | VT-1161 600mg BID | 0 | 14 | 3 | 14 | |||
| EG003 | Fluconazole 150mg | 0 | 15 | 10 | 15 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders |
| |||
| Conjunctivitis | Eye disorders |
| |||
| Abdominal Pain | Gastrointestinal disorders |
| |||
| Nausea | Gastrointestinal disorders |
| |||
| Conjunctivitis Bacterial | Infections and infestations |
| |||
| Ear Infection | Infections and infestations |
| |||
| Herpes Simplex | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Nasopharyngitis | Infections and infestations |
| |||
| Esophageal Candidiasis | Infections and infestations |
| |||
| Pharyngitis | Infections and infestations |
| |||
| Sinusitits | Infections and infestations |
| |||
| Trichamoniasis | Infections and infestations |
| |||
| Upper Respiratory Tract Infection | Infections and infestations |
| |||
| Urinary Tract Infection | Infections and infestations |
| |||
| Vaginitis Bacterial | Infections and infestations |
| |||
| Laceration | Injury, poisoning and procedural complications |
| |||
| Liver Function Test Abnormal | Investigations |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Pain in Extremity | Musculoskeletal and connective tissue disorders |
| |||
| Carpal Tunnel Syndrome | Nervous system disorders |
| |||
| Dizziness | Nervous system disorders |
| |||
| Dysgeusia | Nervous system disorders |
| |||
| Headache | Nervous system disorders |
| |||
| Pregnancy | Pregnancy, puerperium and perinatal conditions |
| |||
| Insomnia | Psychiatric disorders |
| |||
| Urine Odor Abnormal | Renal and urinary disorders |
| |||
| Dysmenorrhea | Reproductive system and breast disorders |
| |||
| Dyspareunia | Reproductive system and breast disorders |
| |||
| Fibrocystic Breast Disease | Reproductive system and breast disorders |
| |||
| Metrorrhagia | Reproductive system and breast disorders |
| |||
| Uterine Hemorrhage | Reproductive system and breast disorders |
| |||
| Vaginal Discharge | Reproductive system and breast disorders |
| |||
| Vulvovaginal Pruritus | Reproductive system and breast disorders |
| |||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Dermatitis Contact | Skin and subcutaneous tissue disorders |
| |||
| Erythema | Skin and subcutaneous tissue disorders |
| |||
| Pruritus | Skin and subcutaneous tissue disorders |
| |||
| Urticaria | Skin and subcutaneous tissue disorders |
| |||
| Hematoma | Vascular disorders |
|
Neither institution nor principal investigator shall publish the results of the trial without prior written consent of the sponsor, which it may withhold in its sole discretion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Neil Moore | Viamet Pharmaceuticals Inc | nmoore@viamet.com |
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000599187 | VT-1161 |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Male |
|