NCT03469583 is a Phase 1 clinical trial of EYP001 in Hepatitis B, Chronic, sponsored by Enyo Pharma.

Who is sponsoring NCT03469583?

NCT03469583 is sponsored by Enyo Pharma.

What drugs are being tested in NCT03469583?

Interventions in NCT03469583: EYP001, Entecavir 1 MG.

What condition does NCT03469583 study?

NCT03469583 studies Hepatitis B, Chronic.

Is NCT03469583 still recruiting?

NCT03469583 is currently completed. Last updated 26 July 2018.

Last reviewed 2018-07-26 · How we verify

NCT03469583

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

Drug Drug Interaction Study for EYP001 With Entecavir

Completed Phase 1 Last updated 26 July 2018

What this trial tests

Phase 1 trial testing EYP001 in Hepatitis B, Chronic in 16 participants. Completed in 20 July 2018.

Timeline

12 February 2018

Primary endpoint
20 June 2018

20 July 2018

Quick facts

Lead sponsor	Enyo Pharma
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	sequential
Masking	none
Primary purpose	treatment
Enrollment	16
Start date	12 February 2018
Primary completion	20 June 2018
Estimated completion	20 July 2018
Sites	1 location across Australia

Drugs / interventions tested

EYP001 — full drug profile →
Entecavir 1 MG — full drug profile →

Conditions studied

Hepatitis B, Chronic — all drugs for Hepatitis B, Chronic →

Sponsor

Enyo Pharma — full company profile →

Who can join

Adults 18 to 60, any sex, with Hepatitis B, Chronic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of EYP100a combined with ETV in healthy men and women dosed in the morning under fasted conditions.

Publications & conference data

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

Development of Direct-acting Antiviral and Host-targeting Agents for Treatment of Hepatitis B Virus Infection.
Xia Y, Liang TJ. · · 2019 · cited 91× · PMID 30243618 · DOI 10.1053/j.gastro.2018.07.057
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
Nuclear receptors in health and disease: signaling pathways, biological functions and pharmaceutical interventions.
Jin P, Duan X, Huang Z, Dong Y, et al · · 2025 · cited 21× · PMID 40717128 · DOI 10.1038/s41392-025-02270-3

Verify or expand the search:

Other recruiting trials for Hepatitis B, Chronic

Currently open trials in the same condition.

NCT07370207 — Phase 2 Study of AHB-137 in HBeAg Negative Chronic Hepatitis B (CHB) Participants in Asia Pacific Region · Phase 2 · recruiting
NCT06550622 — Improved Sensitivity Detection of Serum HBsAg and HBsAg Reversion · recruiting
NCT06550128 — Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB). · Phase 2 · active not recruiting
NCT06525909 — A Real-world Study of Staging and Grading of Clinical Immune Status in Chronic Hepatitis B · recruiting
NCT05937178 — Real-world Study Optimizing Nucleotide-analogues · recruiting

Other Enyo Pharma trials

Trials by the same sponsor.

NCT07251153 — Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions · Phase 1 · recruiting
NCT06939816 — Vonafexor in Patients With Impaired Renal Function and Suspected MASH (Metabolic Dysfunction-associated Steatohepatitis) · Phase 2 · recruiting
NCT06425055 — Vonafexor ALPort Syndrome Efficacy & Safety TRIAl-1 (ALPESTRIA-1) · Phase 2 · completed
NCT04365933 — A Study of the Oral Farnesoid X Receptor Modulator EYP001a to Assess Its Safety and Anti-viral Effect in Chronic Hepatit · Phase 2 · completed
NCT04465916 — Study of EYP001a to Assess Its Safety and Anti-viral Effect in CHB Patients in Combination With NA (ETV or TD) · Phase 2 · terminated

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 NCT03469583 (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 Enyo Pharma
Last refreshed: 26 July 2018

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/NCT03469583.

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