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

Chronic HBV Infection Clinical Trial

Official title:

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04008004
• Other study ID #: EDP 514-001
• Status: Completed
• Phase: Phase 1
• Start date: June 26, 2019
• Est. completion date: July 14, 2021

Study information

• Verified date: May 2021
• Source: Enanta Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: July 14, 2021
• Est. primary completion date: July 14, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Part 1 (HV 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 65 years, inclusive.

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):

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

Related Conditions & MeSH terms

• Chronic HBV Infection
• Communicable Diseases
• Hepatitis
• Hepatitis B
• Hepatitis B, Chronic
• Herpesviridae Infections
• Infections
• Virus Diseases

Intervention

Drug:
• 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).
• Placebo
Placebo to match EDP-514

Locations

Country	Name	City	State
Canada	University Of Calgary	Calgary	Alberta
Canada	Centre Hospitalier de l'Université de Montréal	Montréal	Quebec
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Gastroenterology Institute of Research Institute	Vancouver	British Columbia
United States	Digestive Disease Associates - Catonsville	Catonsville	Maryland
United States	Southern California GI and Liver Centers	Coronado	California
United States	American Research Corporation	Houston	Texas
United States	Pharmaceutical Research Associates, Inc.	Lenexa	Kansas
United States	University of California Los Angeles	Los Angeles	California
United States	University of Miami Miller School of Medicine	Miami	Florida
United States	Icahn School of Medicine at Mount Sinai	New York	New York
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	Quest Clinical Research	San Francisco	California
United States	Swedish Organ Transplant and Liver Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Enanta Pharmaceuticals	Pharmaceutical Research Associates

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety measured by adverse events		Up to 8 Days in HV SAD Cohorts
Primary	Safety measured by adverse events		Up to 21 Days in HV MAD Cohorts
Primary	Safety measured by adverse events		Up to 56 Days in HBV MAD Cohorts
Secondary	Cmax of EDP-514		Up to 6 Days in HV SAD Cohorts
Secondary	AUC of EDP-514		Up to 6 Days in HV SAD Cohorts
Secondary	Cmax of EDP-514		Up to 18 Days in HV MAD Cohorts
Secondary	AUC of EDP-514		Up to 18 Days in HV MAD Cohorts
Secondary	Cmax of EDP-514		Up to 28 Days in HBV MAD Cohorts
Secondary	AUC of EDP-514		Up to 28 Days in HBV MAD Cohorts