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Albaconozole

Phase 1

Onychomycosis | Small molecule | Other |GSK plc|Last Updated: Jun 20, 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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01014962A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail FungusPHASE1 COMPLETED 24Aug 24, 2009Dec 4, 2009Jun 20, 20171 United States
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Study Endpoints
Primary Endpoints
Plasma concentrations of albaconazole in subjects
During 5 days of dosing and 15 days follow-up
Secondary Endpoints
Electrocardiogram (ECG) QTc values
During 5 days of dosing and 15 days follow-up
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
Albaconazole 400 mg cohort 1EXPERIMENTALAlbaconazole 400 mg
Placebo cohort 1PLACEBO_COMPARATORPlacebo once daily
Albaconozole 400 mg cohort 2EXPERIMENTALAlbaconozole 400 mg every 12 hours
Placebo cohort 2PLACEBO_COMPARATORPlacebo every 12 hours
Albaconozole 400 mg cohort 3EXPERIMENTALAlbaconozole 400 mg every 8 hours
Placebo cohort 3PLACEBO_COMPARATORPlacebo every 8 hours
Interventions
NameTypeDescription
AlbaconozoleDRUGAlbaconozole 400 mg oral once daily for 5 days
PlaceboDRUGPlacebo oral once daily for 5 days
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Eligibility Criteria
Age Range18 Years — 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Male or female subjects age 18 to 45 * A body mass index (BMI) between 18.5 and 30 kg/m2. * Good physical and mental health. * Vital signs .within the acceptable range. * Electrocardiogram (12-lead) after at least 5 minutes in supine position considered as normal or with findi...

Countries:United States
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