Recent Updates
Recently added Catalysts

W0027

Phase 1

Tinea Pedis | Small molecule | Infectious Disease |GSK plc|Trials Updated: May 30, 2017

W0027 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2001

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment120

FDA Designations

No designations recorded

W0027 clinical trials

W0027 · 1 trial · 1 indication

Phase 1 1
NCT00509275A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)Tinea Pedis
COMPLETED120 Analytics
PHASE1COMPLETED
A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)
Tinea PedisUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary objective of this study is to assess the subject response to three W0027 regimens in subjects with MTTP.
Week 8

Secondary Endpoints

The secondary objectives of this study are: To assess the safety and tolerability of three W0027 regimens in subjects with MTTP; To assess skin and nail pharmacokinetics of three Albaconazole doses in subjects with MTTP.
Skin and Plasma samples Week 0 (Visit 2) through to Week 8 (Visit 9), Nail samples Week 0 (Visit 2) Week 4(Visit 7) and Week 8(Visit 9)
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
1EXPERIMENTALW0027
2EXPERIMENTALW0027
3EXPERIMENTALW0027
4PLACEBO_COMPARATORPlacebo

Interventions

NameTypeDescription
W0027DRUGcapsule
PlaceboDRUGPlacebo
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Subjects aged 18-65 years, who have been diagnosed with moccasin type tinea pedis (by positive dermatophyte culture, positive potassium hydroxide/calcofluor white preparation, and a Total Signs and Symptoms Score of at least 4). * Females of childbearing potential must use con...

Countries:United StatesAustralia
Unlock Eligibility Criteria

Frequently asked questions about W0027

What is W0027 used for?

W0027 is an investigational small molecule developed by GSK plc for the treatment of tinea pedis, commonly known as athlete's foot. It has been studied specifically in the moccasin type of tinea pedis, a chronic form affecting the sole and side of the foot.

Who is developing W0027?

W0027 is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical research evaluating the compound in patients with moccasin type tinea pedis.

What phase is W0027 in?

W0027 is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. The Phase 1 trial evaluating it has been completed.

What clinical trials has W0027 been studied in?

W0027 has been evaluated in one clinical trial, NCT00509275, titled a study to evaluate efficacy and safety of three W0027 regimens in the treatment of moccasin type tinea pedis. The trial was Phase 1, completed, randomized, double blind, and placebo controlled, enrolling 120 participants across the United States and Australia.

How was the W0027 trial designed?

The W0027 trial NCT00509275 was a randomized, double blind, placebo controlled Phase 1 study. It enrolled 120 adults aged 18 years and older of all sexes and evaluated three W0027 regimens in patients with moccasin type tinea pedis. The study was conducted in the United States and Australia and has been completed.