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W0027

Phase 1

Tinea Pedis | Small molecule | Other |GSK plc|Last Updated: May 30, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00509275A Study to Evaluate Efficacy and Safety of Three W0027 Regimens in the Treatment of Moccasin Type Tinea Pedis (MTTP)PHASE1 COMPLETED 120Jul 1, 2007Aug 1, 2008May 30, 20179 United States, Australia
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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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALW0027
2EXPERIMENTALW0027
3EXPERIMENTALW0027
4PLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
W0027DRUGcapsule
PlaceboDRUGPlacebo
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Eligibility Criteria
Age Range18 Years — 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
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