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

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ClinicalTrials.gov Identifier: NCT04008004
Recruitment Status : Recruiting
First Posted : July 5, 2019
Last Update Posted : July 20, 2020
Sponsor:
Collaborator:
Pharmaceutical Research Associates
Information provided by (Responsible Party):
Enanta Pharmaceuticals

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


Condition or disease Intervention/treatment Phase
Chronic HBV Infection Drug: EDP-514 Drug: Placebo Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : June 26, 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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
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).

Experimental: EDP-514 HV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 14 days
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 Comparator: EDP-514 HV SAD Placebo Cohort
Matching placebo, orally, once daily in one single administration
Drug: Placebo
Placebo to match EDP-514

Placebo Comparator: EDP-514 HV MAD Placebo Cohort
Matching placebo, orally, once daily for 14 days
Drug: Placebo
Placebo to match EDP-514

Experimental: EDP-514 HBV MAD Cohorts
EDP-514 Dose 1, Dose 2 and Dose 3 orally, once daily for 28 days
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 Comparator: EDP-514 HBV MAD Placebo Cohort
Matching placebo, orally, once daily for 28 days
Drug: Placebo
Placebo to match EDP-514




Primary Outcome Measures :
  1. Safety measured by adverse events [ Time Frame: Up to 8 Days in HV SAD Cohorts ]
  2. Safety measured by adverse events [ Time Frame: Up to 21 Days in HV MAD Cohorts ]
  3. Safety measured by adverse events [ Time Frame: Up to 56 Days in HBV MAD Cohorts ]

Secondary Outcome Measures :
  1. Cmax of EDP-514 [ Time Frame: Up to 6 Days in HV SAD Cohorts ]
  2. AUC of EDP-514 [ Time Frame: Up to 6 Days in HV SAD Cohorts ]
  3. Cmax of EDP-514 [ Time Frame: Up to 18 Days in HV MAD Cohorts ]
  4. AUC of EDP-514 [ Time Frame: Up to 18 Days in HV MAD Cohorts ]
  5. Cmax of EDP-514 [ Time Frame: Up to 28 Days in HBV MAD Cohorts ]
  6. AUC of EDP-514 [ Time Frame: Up to 28 Days in HBV MAD Cohorts ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04008004


Contacts
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Contact: Enanta Pharmaceuticals, Inc +1 617 607 0705 nadda@enanta.com

Locations
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United States, California
Southern California GI and Liver Centers Recruiting
Coronado, California, United States, 92118
Contact: Tarek Hassanein         
Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.) Active, not recruiting
San Diego, California, United States, 92105
Quest Clinical Research Active, not recruiting
San Francisco, California, United States, 94115
United States, Kansas
Pharmaceutical Research Associates, Inc. Completed
Lenexa, Kansas, United States, 66219
United States, Texas
American Research Corporation Recruiting
Houston, Texas, United States, 77030
Contact: Joseph Galati         
The Texas Liver Institute Recruiting
San Antonio, Texas, United States, 78215
Contact: Eric Lawitz, MD         
Sponsors and Collaborators
Enanta Pharmaceuticals
Pharmaceutical Research Associates
Investigators
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Study Director: Enanta Pharmaceuticals, Inc Enanta Pharmaceuticals, Inc
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Responsible Party: Enanta Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04008004    
Other Study ID Numbers: EDP 514-001
First Posted: July 5, 2019    Key Record Dates
Last Update Posted: July 20, 2020
Last Verified: May 2020

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Enanta Pharmaceuticals:
"First-in-Human"
Single Ascending Dose
Multiple Ascending Dose
hepatitis B virus
HBV
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Hepatitis B
Hepatitis B, Chronic
Virus Diseases
Herpesviridae Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Hepadnaviridae Infections
DNA Virus Infections
Hepatitis, Chronic