The purpose of this study is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster.
In cells infected with varicella-zoster virus, there is evidence to suggest that EPB-348 could offer clinically important advantages in the treatment of acute herpes zoster over currently available therapies due to rapid absorption and conversion to the active moiety as well as a longer intra-cellular half-life in infected cells. Clinically, these characteristics could translate into once-daily dosing versus thrice-daily dosing as seen with current therapy, leading to a higher rate of compliance and quality-of-life, especially among elderly patients. The objective of EPB348-0201 is to determine the pharmacokinetics and dosage of EPB-348 that best balances safety and efficacy among adult immunocompetent patients with an acute episode of herpes zoster. This multi-center study will randomly assign patients to either EPB-348 1000 mg once daily or EPB-348 2000 mg once daily or valacyclovir 1000 mg three times daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
373
Treated over seven days
Treated over seven days
Center for Clinical Studies-Medical Center
Houston, Texas, United States
To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm.
Time frame: Daily assessment during the seven days of treament then weekly until Day 28
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