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Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects

NCT03272009 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 73

Last updated 2018-08-21

No results posted yet for this study

Summary

Bile acids regulating farnesoid X receptor (FXR) interact with hepatitis B virus replication. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.

This Phase 1b study is designed primarily to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of EYP001a in chronically HBV infected subjects.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

EYP001a

Capsules administered orally. Number of morning and evening capsules depending on treatment arm

DRUG

Placebo

Placebo capsules for oral administration, identical in appearance to the EYP001a capsules

DRUG

Entecavir

Tablets administered orally

DRUG

peg-interferon alfa-2a

Ready-to-Use pre-filled syringes for subcutaneous injection

Sponsors & Collaborators

  • CPR Pharma Services Pty Ltd, Australia

    collaborator INDUSTRY

  • Enyo Pharma

    lead INDUSTRY

Principal Investigators

  • Henk W Reesink, MD · Academic Medical Centre AMC Amsterdam

  • Stephan Riordan · Scientia Clinical Research Limited Sydney

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2018-07-30
Completion
2018-07-30

Countries

  • Australia
  • Netherlands
  • Poland
  • Thailand

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272009 on ClinicalTrials.gov