A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)

Completed · Phase 1 · Has a placebo group

Conditions studied: Chronic HBV Infection

In brief

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

Key facts

Study ID

NCT04008004

Run by

Enanta Pharmaceuticals, Inc

People needed

99

Starts

2019-06-26

Expected to finish

2021-07-14

Last updated by the study team

2022-01-11

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• An informed consent document signed and dated by the subject.
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 65 years, inclusive.

You may not qualify if…

• Clinically relevant evidence or history of illness or disease.
• Pregnant or nursing females.
• History of febrile illness within 7 days prior to the first dose of study drug or subjects with evidence of active infection.
• A positive urine drug screen at screening or Day -1.
• Current tobacco smokers or use of tobacco within 3 months prior to screening.
• Any condition possibly affecting drug absorption (e.g., gastrectomy, cholecystectomy).
• History of regular alcohol consumption.
• Receipt of any vaccine, an investigational agent or biological product within 28 days or 5 times the t½, whichever one is longer, prior to first dose. This includes agents administered during clinical trial participation.
• Part 2 (HBV Population):
• Inclusion Criteria:
• An informed consent document signed and dated by the subject.
• Healthy male and female subjects of any ethnic origin between the ages of 18 and 70 years, inclusive
• HBV DNA levels:
• A Screening HBV DNA level in serum/plasma that is <LLOQ and
• No HBV DNA serum/plasma test values ≥LLOQ over the previous 12 months (using an approved test)
• CHB subjects must have been on their prescribed HBV NUC treatment with no change in regimen for 12 months prior to Screening
• Exclusion Criteria:
• A documented prior diagnosis of cirrhosis
• Pregnant or nursing females
• Coinfection with human immunodeficiency virus (HIV), HCV, HDV, HAV, or HEV
• Chronic liver disease of a non-HBV etiology; coexisting liver or biliary diseases

Where it is running

• 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
• Swedish Organ Transplant and Liver Center — Seattle, Washington, United States
• University Of Calgary — Calgary, Alberta, Canada
• Gastroenterology Institute of Research Institute — Vancouver, British Columbia, Canada
• Toronto General Hospital — Toronto, Ontario, Canada
• Centre Hospitalier de l'Université de Montréal — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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