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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 moderate - severe tinea pedis (also referred to as athletes foot). 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. A safer antifungal drug would improve treatment options for infections seen in otherwise healthy individuals where significant side-effect risks are unacceptable.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VT-1161 200/50mg | Experimental |
| |
| VT-1161 600/150mg | Experimental |
| |
| VT-1161 1200/300mg | Experimental |
| |
| Matching placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VT-1161 | Drug |
| ||
| placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture. | 6 weeks |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univ Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| Florida Academic Dermatology Center |
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| ID | Title | Description |
|---|---|---|
| FG000 | VT-1161 200/50mg | VT-1161 200mg once daily for 4 days, then VT-1161 50mg once daily for 10 days |
| FG001 | VT-1161 600/150mg | VT-1161 600mg once daily for 4 days, then VT-1161 150mg once daily for 10 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Drug |
|
| Miami |
| Florida |
| 33136 |
| United States |
| FXM Research | Miramar | Florida | 33027 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Oregon Dermatology & Research Center | Portland | Oregon | 97210 | United States |
| J&S Studies, Inc. | College Station | Texas | 77845 | United States |
| Pariser Dermatology Specialists | Norfolk | Virginia | 23507 | United States |
| FG002 | VT-1161 1200/300mg | VT-1161 1200mg once daily for 4 days, then VT-1161 300mg once daily for 10 days |
| FG003 | Placebo | matching tablets over-encapsulated for blinding purposes |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VT-1161 200/50mg | |
| BG001 | VT-1161 600/150mg | |
| BG002 | VT-1161 1200/300mg | |
| BG003 | Matching Placebo | |
| 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 42 Days for All-analysis Population | For this trial, therapeutic cure was defined as clinical AND mycological cure. Clinical cure was defined as the absence of signs and symptoms of clinical disease. Mycological cure was defined as a negative KOH test and a negative fungal culture. | Posted | Count of Participants | Participants | 6 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 200/50mg | 0 | 12 | 2 | 12 | |||
| EG001 | VT-1161 600/150mg | 0 | 12 | 3 | 12 | |||
| EG002 | VT-1161 1200/300mg | 0 | 14 | 5 | 14 | |||
| EG003 | Matching Placebo | 0 | 12 | 5 | 12 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders |
| |||
| Abdominal Discomfort | Gastrointestinal disorders |
| |||
| Constipation | Gastrointestinal disorders |
| |||
| Herpes Zoster | Infections and infestations |
| |||
| Influenza | Infections and infestations |
| |||
| Oral Herpes | Infections and infestations |
| |||
| Sinusitis | Infections and infestations |
| |||
| Tooth Infection | Infections and infestations |
| |||
| Blood Pressure Increased | Investigations |
| |||
| Back Pain | Musculoskeletal and connective tissue disorders |
| |||
| Ectopic Pregnancy | Pregnancy, puerperium and perinatal conditions |
| |||
| Nephrolithiasis | Renal and urinary disorders |
| |||
| Pyuria | Renal and urinary disorders |
| |||
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders |
| |||
| Paranasal Sinusitis | Respiratory, thoracic and mediastinal disorders |
| |||
| Rash | Skin and subcutaneous tissue 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 |
|---|---|
| D014008 | Tinea Pedis |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D005533 | Foot Dermatoses |
| D005534 | Foot Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011537 | Pruritus |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C000599187 | VT-1161 |
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| Male |
|