NCT04783753 is a Phase 1 clinical trial of EDP-514 in Hepatitis B, sponsored by Enanta Pharmaceuticals, Inc.

Who is sponsoring NCT04783753?

NCT04783753 is sponsored by Enanta Pharmaceuticals, Inc.

What drugs are being tested in NCT04783753?

Interventions in NCT04783753: EDP-514, EDP-514, EDP-514, Itraconazole, Carbamazepin, Quinidine.

What condition does NCT04783753 study?

NCT04783753 studies Hepatitis B.

Is NCT04783753 still recruiting?

NCT04783753 is currently completed. Last updated 16 August 2021.

Last reviewed 2021-08-16 · How we verify

NCT04783753

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Drug-Drug Interaction Study Between EDP-514, Itraconazole, Carbamazepine, and Quinidine in Healthy Subjects

Completed Phase 1 Last updated 16 August 2021

What this trial tests

Phase 1 trial testing EDP-514 in Hepatitis B in 72 participants. Completed in 9 July 2021.

Timeline

5 November 2020

Primary endpoint
28 June 2021

9 July 2021

Quick facts

Lead sponsor	Enanta Pharmaceuticals, Inc
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	72
Start date	5 November 2020
Primary completion	28 June 2021
Estimated completion	9 July 2021
Sites	1 location across United States

Drugs / interventions tested

EDP-514 — full drug profile →
EDP-514 — full drug profile →
EDP-514 — full drug profile →
Itraconazole — full drug profile →
Carbamazepin — full drug profile →
Quinidine — full drug profile →

Conditions studied

Hepatitis B — all drugs for Hepatitis B →

Sponsor

Enanta Pharmaceuticals, Inc — full company profile →

Who can join

Adults 18 to 55, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Non-randomized, 3-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of itraconazole, carbamazepine, or quinidine on the PK and safety of EDP-514 in healthy adult subjects.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The progress of molecules and strategies for the treatment of HBV infection.
Pan Y, Xia H, He Y, Zeng S, et al · · 2023 · cited 33× · PMID 37009498 · DOI 10.3389/fcimb.2023.1128807
The premise of capsid assembly modulators towards eliminating HBV persistence.
Bassit L, Amblard F, Patel D, Biteau N, et al · · 2023 · cited 19× · PMID 37477111 · DOI 10.1080/17460441.2023.2239701

Verify or expand the search:

Other trials of EDP-514

Trials testing the same drug.

NCT04971512 — A 2 PART STUDY EVALUATING EDP-721 IN HEALTHY SUBJECTS AND EDP-721 IN COMBINATION WITH EDP-514 IN PATIENTS WITH CHRONIC H · Phase 1 · terminated
NCT04470388 — A Study of EDP-514 in Patients With Chronic Hepatitis B Virus Infection Who Are Not Currently on Treatment · Phase 1 · completed
NCT04008004 — A Study of EDP-514 in Healthy Subjects (Part 1) and Patients With Chronic Hepatitis B Virus Infection (Part 2) · Phase 1 · completed

Other recruiting trials for Hepatitis B

Currently open trials in the same condition.

NCT04843852 — TLR-9 Adjuvanted Vaccination for Chronic Hepatitis B · Phase 1 · recruiting
NCT07168356 — A Study to Evaluate Blood Levels of Bepirovirsen in Adult Participants With Severe or Moderate Kidney Disease · Phase 1 · recruiting
NCT06947356 — Comparison of TAF and TDF in Preventing Mother-to-Child Transmission of HBV in Pregnancies With High Viral Loads · NA · recruiting
NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting

Other Enanta Pharmaceuticals, Inc trials

Trials by the same sponsor.

NCT06917508 — A Study to Evaluate the Drug-Drug Interaction of EDP-323 With Midazolam, Caffeine, and Rosuvastatin in Healthy Participa · Phase 1 · completed
NCT06847464 — A Drug-Drug Interaction Study to Evaluate the Effects of Itraconazole, Carbamazepine, Quinidine and Fluconazole on the P · Phase 1 · completed
NCT06601192 — A Study to Investigate the Effects of Zelicapavir (EDP-938) on QTc Interval in Healthy Adults · Phase 1 · completed
NCT06170242 — A Controlled Phase 2a Study to Evaluate the Efficacy of EDP-323 Against Respiratory Syncytial Virus Infection in a Virus · Phase 2 · completed
NCT05568706 — A Study of EDP-938 in Non-hospitalized Adults With RSV Who Are at High Risk for Complications. · Phase 2 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04783753 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Enanta Pharmaceuticals, Inc
Last refreshed: 16 August 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04783753.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing