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NCT04008004 · ClinicalTrials.gov registry record · Phase 1

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

A Phase 1 study, sponsored by Enanta Pharmaceuticals.

Completed
Registry status
Phase 1
Development phase
99
Enrollment target

NCT04008004 is a Phase 1 study that has completed, run by Enanta Pharmaceuticals. The registered enrollment target is 99 participants.

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The verdict

NCT04008004, a Phase 1 study, has completed, sponsored by Enanta Pharmaceuticals.

COMPLETED
Registry status
Phase 1
Development phase
99 participants
Enrollment target

Study 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

Interventions

  • DRUG Placebo
  • DRUG EDP-514

Trial Details

FieldValue
Enrollment Target 99 participants
Start Date 2019-06-26
Est. Completion 2021-07-14
Phase Phase 1

Sponsor

Enanta Pharmaceuticals

36 total trials

What the Registry Record Tells You About NCT04008004

The ClinicalTrials.gov registry entry for NCT04008004 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 99 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Enanta Pharmaceuticals, which has 36 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT04008004 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT04008004 about?

NCT04008004 is a clinical study titled "A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2)". 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 ...

What is the current status of trial NCT04008004?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 99 participants. The study started on 2019-06-26. Estimated completion is 2021-07-14.

What interventions are being tested in trial NCT04008004?

The interventions under investigation include: Placebo (DRUG), EDP-514 (DRUG).

Who is sponsoring clinical trial NCT04008004?

This trial is sponsored by Enanta Pharmaceuticals, which has 36 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.