A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)
Public ClinicalTrials.gov record NCT04008004. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04008004
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 99 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 25, 2019
- Primary completion
- Jul 13, 2021
- Completion
- Jul 13, 2021
- Last update posted
- Jan 10, 2022
2019 – 2021
United States locations
- U.S. sites
- 11
- U.S. states
- 7
- U.S. cities
- 11
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California GI and Liver Centers | Coronado | California | 92118 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| Tuan Nguyen Md Gastroenterology & Hepatology (Tuan Nguyen, M.D., Inc.) | San Diego | California | 92105 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | — |
| Pharmaceutical Research Associates, Inc. | Lenexa | Kansas | 66219 | — |
| Digestive Disease Associates - Catonsville | Catonsville | Maryland | 21228 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| American Research Corporation | Houston | Texas | 77030 | — |
| The Texas Liver Institute | San Antonio | Texas | 78215 | — |
| Swedish Organ Transplant and Liver Center | Seattle | Washington | 98104 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 4 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04008004, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 10, 2022 · Synced Sep 1, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04008004 live on ClinicalTrials.gov.