A Phase 2 interventional study of VT-1161 and placebo in Tinea Pedis, sponsored by Viamet. Completed at 7 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-08-01.
Sponsored by Viamet · Phase 2, Interventional, and Treatment
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.
73 studies on the registry are indexed under Tinea Pedis; 8 are open to participants now.
This study's enrollment of 50 is below the median of 128 across 66 interventional studies indexed under Tinea Pedis.
Browse Tinea Pedis studies →Viamet is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: VT-1161
Drug: VT-1161
Drug: VT-1161
Drug: placebo
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.
Time frame: 6 weeks
| Milestone | VT-1161 200/50mg | VT-1161 600/150mg | VT-1161 1200/300mg | Placebo |
|---|---|---|---|---|
| Started | 12 | 12 | 14 | 12 |
| Completed | 9 | 11 | 11 | 12 |
| Not completed | 3 | 1 | 3 | 0 |
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.
| Participants | VT-1161 200/50mg | VT-1161 600/150mg | VT-1161 1200/300mg | Matching Placebo |
|---|---|---|---|---|
| Percentage of Subjects With Therapeutic Cure at 42 Days for All-analysis Population | 2 | 1 | 3 | 0 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| VT-1161 200/50mg | — | 0/12 (0%) | 2/12 (16.7%) |
| VT-1161 600/150mg | — | 0/12 (0%) | 3/12 (25%) |
| VT-1161 1200/300mg | — | 0/14 (0%) | 5/14 (35.7%) |
| Matching Placebo | — | 0/12 (0%) | 5/12 (41.7%) |
| Event | VT-1161 200/50mg | VT-1161 600/150mg | VT-1161 1200/300mg | Matching Placebo |
|---|---|---|---|---|
| AnemiaBlood and lymphatic system disorders | 0/12 | 0/12 | 0/14 | 1/12 |
| Abdominal DiscomfortGastrointestinal disorders | 0/12 | 1/12 | 0/14 | 0/12 |
| Herpes ZosterInfections and infestations | 1/12 | 0/12 | 0/14 | 0/12 |
| InfluenzaInfections and infestations | 1/12 | 0/12 | 1/14 | 0/12 |
| Oral HerpesInfections and infestations | 0/12 | 0/12 | 0/14 | 1/12 |
| SinusitisInfections and infestations | 0/12 | 0/12 | 0/14 | 1/12 |
| Blood Pressure IncreasedInvestigations | 0/12 | 1/12 | 0/14 | 0/12 |
| Back PainMusculoskeletal and connective tissue disorders | 0/12 | 0/12 | 1/14 | 1/12 |
| Ectopic PregnancyPregnancy, puerperium and perinatal conditions | 0/12 | 0/12 | 0/14 | 1/12 |
| NephrolithiasisRenal and urinary disorders | 0/12 | 0/12 | 0/14 | 1/12 |
| Age, Continuous(years) | VT-1161 200/50mg | VT-1161 600/150mg | VT-1161 1200/300mg | Matching Placebo | Total |
|---|---|---|---|---|---|
| Mean | 46 ± 12.84 | 40.6 ± 11.71 | 34.05 ± 12.02 | 35.2 ± 10.27 | 38.9 ± 12.32 |
| Sex: Female, Male(Participants) | VT-1161 200/50mg | VT-1161 600/150mg | VT-1161 1200/300mg | Matching Placebo | Total |
|---|---|---|---|---|---|
| Female | 3 | 2 | 3 | 5 | 13 |
| Male | 9 | 10 | 11 | 7 | 37 |
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: VT-1161
Viamet