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Albaconozole

Phase 1

Onychomycosis | Small molecule | Infectious Disease |GSK plc|Last Updated: Jun 20, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment24

FDA Designations

No designations recorded

Clinical trial landscape

Albaconozole · 1 trial · 1 indication

Phase 1 1
NCT01014962A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail FungusOnychomycosis
COMPLETED24 Analytics
PHASE1COMPLETED
A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus
OnychomycosisUnlock trial analytics

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 to 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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Frequently asked questions about Albaconozole

What is Albaconozole used for?

Albaconozole is an investigational small molecule being developed for the treatment of onychomycosis, a fungal infection of the nail. It is currently in Phase 1 clinical development and has not been approved by the FDA.

Who makes Albaconozole?

Albaconozole is being developed by GSK plc, which trades on the New York Stock Exchange under the ticker symbol GSK. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with onychomycosis.

What phase is Albaconozole in?

Albaconozole is in Phase 1 clinical development. It is an investigational drug and has not yet received regulatory approval. The drug is being studied for the treatment of onychomycosis, a fungal nail infection.

What clinical trials is Albaconozole in?

Albaconozole has one completed Phase 1 clinical trial, identified as NCT01014962. This study, titled "A Study of the Effects of Increasing Doses of a Drug for the Treatment of Nail Fungus," enrolled 24 participants in the United States and was a randomized, double-blind, placebo-controlled trial.

Is Albaconozole the same as any other drug?

Albaconozole is the primary name for this investigational drug. No alternative names have been reported in the available clinical trial information. It is being studied under the name Albaconozole in the treatment of onychomycosis.