Herpes Zoster
Conditions
Keywords
EPB348, Valomaciclovir Stearate, Valacyclovir, Herpes Zoster, Shingles
Brief summary
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.
Detailed description
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.
Interventions
DRUGEPB-348
Treated over seven days
DRUGValacyclovir
Treated over seven days
Sponsors
Epiphany Biosciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female adults at least 18 years of age * Patients with signs and symptoms consistent with acute herpes zoster disease, namely, a dermatomal vesicular rash which may be preceded by pain and parasthesias in the days before vesicular eruption * Herpes Zoster associated rash present for ≤ 72 hours * Patients who are deemed to be immunocompetent based on history and physical exam
Exclusion criteria
* Females who are pregnant or nursing * History or clinical manifestations of significant metabolic, hematological, pulmonary, ischemic, or unstable heart disease, gastrointestinal, neurological, psychiatric, renal, urological, endocrine, opthalmologic, or immune mediated disease including HIV or HBsAg positivity * Chronic genital herpes * Patients who received cytotoxic or immunosuppressive drug therapy within 3 months prior to study participation * Previous vaccinations against Herpes Zoster * Patients with \> 50% of vesicles crusted at screen * Patients who received topical or systemic antiviral medications or immunomodulatory agents for herpes zoster viral infections or capsaicin within 4 weeks of study participation * Patients with a history of congenital, acquired, or corticosteroid induced immunodeficiency, including malignancy, significantly impaired renal function (creatinine clearance \< 50 cc/min), and impaired hepatic function (ALT or AST levels \> 3 times the upper limit of normal) * QTc \> 500msec * Patients with a history of intolerance or hypersensitivity to acyclovir, penciclovir, valacyclovir, or famciclovir * Patients with gastrointestinal dysfunction that might interfere with drug absorption * Patients, considered by the investigator, for any reason, to be an unsuitable candidate for receiving the study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the time-to-crusting of vesicles on patients in each of the EPB-348 dosing arms versus the valacyclovir dosing arm. | Daily assessment during the seven days of treament then weekly until Day 28 |
Countries
United States
Outcome results
None listed