Part 1 is a randomized, double-blind, placebo-controlled study. It will assess the safety, tolerability, and pharmacokinetics of single and multiple orally administered doses of EDP-514 in healthy adult subjects. Part 2 is randomized, double -blind, placebo-controlled study including subjects with Hepatitis B Virus. It will assess the safety, tolerability, pharmacokinetics and antiviral activity of 28 Days of orally administered doses of EDP-514 in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection
Part 1 consists of two phases planned in healthy subjects: The first phase assesses single ascending doses for EDP-514 (active drug or placebo) in healthy subjects. A "fasted" and "fed" two-part cohort will also assess food effect. The second phase assesses multiple ascending doses (active drug or placebo) for 14 days in healthy subjects. Each cohort within each phase will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo. The cohort assessing food effect will enroll 10 subjects randomized to receive EDP-514 or placebo. Part 2 assesses multiple ascending doses EDP-514 (active drug or placebo) for 28 days in nucleos(t)ide reverse transcriptase inhibitor (NUC)-Suppressed Patients with Chronic Hepatitis B Virus Infection. Each cohort in Part 2 will enroll a total of 8 subjects who will be randomized to receive EDP-514 or placebo.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
99
Southern California GI and Liver Centers
Coronado, California, United States
University of California Los Angeles
Los Angeles, California, United States
Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Pharmaceutical Research Associates, Inc.
Lenexa, Kansas, United States
Digestive Disease Associates - Catonsville
Catonsville, Maryland, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
American Research Corporation
Houston, Texas, United States
The Texas Liver Institute
San Antonio, Texas, United States
...and 5 more locations
Safety measured by adverse events
Time frame: Up to 8 Days in HV SAD Cohorts
Safety measured by adverse events
Time frame: Up to 21 Days in HV MAD Cohorts
Safety measured by adverse events
Time frame: Up to 56 Days in HBV MAD Cohorts
Cmax of EDP-514
Time frame: Up to 6 Days in HV SAD Cohorts
AUC of EDP-514
Time frame: Up to 6 Days in HV SAD Cohorts
Cmax of EDP-514
Time frame: Up to 18 Days in HV MAD Cohorts
AUC of EDP-514
Time frame: Up to 18 Days in HV MAD Cohorts
Cmax of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
AUC of EDP-514
Time frame: Up to 28 Days in HBV MAD Cohorts
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