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

NCT ID: NCT04008004

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-26
• Study Completion Date: 2021-07-14

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.

Conditions

Chronic HBV Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

EDP-514 HV SAD Cohorts

EDP-514 Dose 1, Dose 2, Dose 3, Dose 4, Dose 5 and Dose 6 orally, once daily in one single administration

Group Type: EXPERIMENTAL

EDP-514

Intervention Type: DRUG

Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).

EDP-514 HV MAD Cohorts

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days

Group Type: EXPERIMENTAL

EDP-514

Intervention Type: DRUG

Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).

EDP-514 HV SAD Placebo Cohort

Matching placebo, orally, once daily in one single administration

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match EDP-514

EDP-514 HV MAD Placebo Cohort

Matching placebo, orally, once daily for 14 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match EDP-514

EDP-514 HBV MAD Cohorts

EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days

Group Type: EXPERIMENTAL

EDP-514

Intervention Type: DRUG

Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).

EDP-514 HBV MAD Placebo Cohort

Matching placebo, orally, once daily for 28 days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo to match EDP-514

Interventions

EDP-514

Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).

Intervention Type: DRUG

Placebo

Placebo to match EDP-514

Intervention Type: DRUG

Eligibility Criteria

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 65 years, inclusive.

• 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

• 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):

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pharmaceutical Research Associates

OTHER

Sponsor Role: collaborator

Enanta Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Enanta Pharmaceuticals, Inc

Role: STUDY_DIRECTOR

Enanta Pharmaceuticals, Inc

Locations

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

Countries

United States; Canada

Other Identifiers

EDP 514-001

Identifier Type: -

Identifier Source: org_study_id