A Study to Evaluate the Efficacy and Safety of Oral VT-1161 in Patients With Moderate - Severe Interdigital Tinea Pedis

• Sponsor: Viamet (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01891305
• Collaborator: (none)
• Enrollment: 50
• Locations: 7
• Arms: 4
• Duration (Months): 16
• Patients Per Site: 7.1
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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 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.

Condition or Disease	Intervention/Treatment	Phase
Tinea Pedis	Drug: VT-1161; Drug: placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: A Phase 2a, Randomized, Double-Blind, Placebo-Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of VT-1161 Oral Tablets in the Treatment of Patients With Moderate to Severe Interdigital Tinea Pedis
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: VT-1161 200/50mg	Drug: VT-1161
Experimental: VT-1161 600/150mg	Drug: VT-1161
Experimental: VT-1161 1200/300mg	Drug: VT-1161
Placebo Comparator: Matching placebo	Drug: placebo

Outcome Measures

Primary Outcome Measures

1. Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population [6 weeks]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Healthy male and non-pregnant female patients ≥18 years and <65 years

• Clinical diagnosis of tinea pedis

• Positive baseline KOH

• Clinical signs and symptoms score of the target lesion is at least 6, including a minimum score of at least 2 for erythema AND a minimum score of 2 for either scaling or pruritus (on a scale of 0-3, where 2 indicates moderate severity)

• Patients must be able to swallow capsules intact

• Use acceptable birth control methods

Key Exclusion Criteria:

• Major organ system disease or clinical infection

• Poorly controlled diabetes mellitus

• Pregnant or lactating

• Confluent, diffuse moccasin-type tinea pedis

• Presence of onychomycosis involving a) more than 5 toe nails, b) any fingernail

• Recent use of topical corticosteroids, topical antibiotics, or topical antifungal therapy to the foot

• Recent use of systemic corticosteroids or antifungal therapy

• Known(HIV)infection

• Known significant hepatic, or hematologic impairment .Requirement for treatment with concomitant antimicrobial or systemic antifungal therapy for any reason.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Univ Alabama at Birmingham	Birmingham	Alabama	United States	35233
2	Florida Academic Dermatology Center	Miami	Florida	United States	33136
3	FXM Research	Miramar	Florida	United States	33027
4	Wake Research Associates	Raleigh	North Carolina	United States	27612
5	Oregon Dermatology & Research Center	Portland	Oregon	United States	97210
6	J&S Studies, Inc.	College Station	Texas	United States	77845
7	Pariser Dermatology Specialists	Norfolk	Virginia	United States	23507

Sponsors and Collaborators

• Viamet

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Viamet
• ClinicalTrials.gov Identifier: NCT01891305
• Other Study ID Numbers: VMT-VT-1161-CL-003
• First Posted: Jul 3, 2013
• Last Update Posted: Aug 1, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Tinea; Tinea Pedis

Study Results

Participant Flow

Arm/Group Title	VT-1161 200/50mg	VT-1161 600/150mg	VT-1161 1200/300mg	Placebo
Arm/Group Description	VT-1161 200mg once daily for 4 days, then VT-1161 50mg once daily for 10 days	VT-1161 600mg once daily for 4 days, then VT-1161 150mg once daily for 10 days	VT-1161 1200mg once daily for 4 days, then VT-1161 300mg once daily for 10 days	matching tablets over-encapsulated for blinding purposes
Period Title: Overall Study
STARTED	12	12	14	12
COMPLETED	9	11	11	12
NOT COMPLETED	3	1	3	0

Baseline Characteristics

Arm/Group Title	VT-1161 200/50mg	VT-1161 600/150mg	VT-1161 1200/300mg	Matching Placebo	Total
Arm/Group Description	Total of all reporting groups
Overall Participants	12	12	14	12	50
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46 (12.84)	40.6 (11.71)	34.05 (12.02)	35.2 (10.27)	38.9 (12.32)
Sex: Female, Male (Count of Participants)
Female	3 25%	2 16.7%	3 21.4%	5 41.7%	13 26%
Male	9 75%	10 83.3%	11 78.6%	7 58.3%	37 74%

Outcome Measures

1. Primary Outcome

Title	Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population
Description	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.
Time Frame	6 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	VT-1161 200/50mg	VT-1161 600/150mg	VT-1161 1200/300mg	Matching Placebo
Arm/Group Description
Measure Participants	12	12	14	12
Count of Participants [Participants]	2 16.7%	1 8.3%	3 21.4%	0 0%

Adverse Events

Arm/Group Title	VT-1161 200/50mg		VT-1161 600/150mg		VT-1161 1200/300mg		Matching Placebo
Arm/Group Description
All Cause Mortality
	VT-1161 200/50mg		VT-1161 600/150mg		VT-1161 1200/300mg		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	VT-1161 200/50mg		VT-1161 600/150mg		VT-1161 1200/300mg		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/12 (0%)		0/12 (0%)		0/14 (0%)		0/12 (0%)
Other (Not Including Serious) Adverse Events
	VT-1161 200/50mg		VT-1161 600/150mg		VT-1161 1200/300mg		Matching Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/12 (16.7%)		3/12 (25%)		5/14 (35.7%)		5/12 (41.7%)
Blood and lymphatic system disorders
Anemia	0/12 (0%)		0/12 (0%)		0/14 (0%)		1/12 (8.3%)
Gastrointestinal disorders
Abdominal Discomfort	0/12 (0%)		1/12 (8.3%)		0/14 (0%)		0/12 (0%)
Constipation	0/12 (0%)		0/12 (0%)		1/14 (7.1%)		0/12 (0%)
Infections and infestations
Herpes Zoster	1/12 (8.3%)		0/12 (0%)		0/14 (0%)		0/12 (0%)
Influenza	1/12 (8.3%)		0/12 (0%)		1/14 (7.1%)		0/12 (0%)
Oral Herpes	0/12 (0%)		0/12 (0%)		0/14 (0%)		1/12 (8.3%)
Sinusitis	0/12 (0%)		0/12 (0%)		0/14 (0%)		1/12 (8.3%)
Tooth Infection	0/12 (0%)		0/12 (0%)		1/14 (7.1%)		0/12 (0%)
Investigations
Blood Pressure Increased	0/12 (0%)		1/12 (8.3%)		0/14 (0%)		0/12 (0%)
Musculoskeletal and connective tissue disorders
Back Pain	0/12 (0%)		0/12 (0%)		1/14 (7.1%)		1/12 (8.3%)
Pregnancy, puerperium and perinatal conditions
Ectopic Pregnancy	0/12 (0%)		0/12 (0%)		0/14 (0%)		1/12 (8.3%)
Renal and urinary disorders
Nephrolithiasis	0/12 (0%)		0/12 (0%)		0/14 (0%)		1/12 (8.3%)
Pyuria	0/12 (0%)		1/12 (8.3%)		0/14 (0%)		0/12 (0%)
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain	0/12 (0%)		0/12 (0%)		1/14 (7.1%)		0/12 (0%)
Paranasal Sinusitis	0/12 (0%)		0/12 (0%)		1/14 (7.1%)		0/12 (0%)
Skin and subcutaneous tissue disorders
Rash	0/12 (0%)		0/12 (0%)		1/14 (7.1%)		0/12 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.