A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
- Registration Number
- NCT04008004
- Lead Sponsor
- Enanta Pharmaceuticals, Inc
- Brief Summary
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
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 99
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description EDP-514 HV MAD Cohorts EDP-514 EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days EDP-514 HV SAD Cohorts EDP-514 EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration EDP-514 HBV MAD Placebo Cohort Placebo Matching placebo, orally, once daily for 28 days EDP-514 HV MAD Placebo Cohort Placebo Matching placebo, orally, once daily for 14 days EDP-514 HV SAD Placebo Cohort Placebo Matching placebo, orally, once daily in one single administration EDP-514 HBV MAD Cohorts EDP-514 EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
- Primary Outcome Measures
Name Time Method Safety measured by adverse events Up to 56 Days in HBV MAD Cohorts
- Secondary Outcome Measures
Name Time Method AUC of EDP-514 Up to 28 Days in HBV MAD Cohorts Cmax of EDP-514 Up to 28 Days in HBV MAD Cohorts
Trial Locations
- Locations (15)
University of Miami Miller School of Medicine
🇺🇸Miami, Florida, United States
American Research Corporation
🇺🇸Houston, Texas, United States
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Swedish Organ Transplant and Liver Center
🇺🇸Seattle, Washington, United States
Icahn School of Medicine at Mount Sinai
🇺🇸New York, New York, United States
Gastroenterology Institute of Research Institute
🇨🇦Vancouver, British Columbia, Canada
Centre Hospitalier de l'Université de Montréal
🇨🇦Montréal, Quebec, Canada
Digestive Disease Associates - Catonsville
🇺🇸Catonsville, Maryland, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Southern California GI and Liver Centers
🇺🇸Coronado, California, United States
Pharmaceutical Research Associates, Inc.
🇺🇸Lenexa, Kansas, United States
University Of Calgary
🇨🇦Calgary, Alberta, Canada
Quest Clinical Research
🇺🇸San Francisco, California, United States
The Texas Liver Institute
🇺🇸San Antonio, Texas, United States
Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.)
🇺🇸San Diego, California, United States