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EYP001a Food Effect Study in Subjects With Chronic Hepatitis B Virus (HBV) Infection

NCT03320616 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2018-03-05

No results posted yet for this study

Summary

The farnesoid X receptor (FXR) regulates hepatitis B virus replication through the bile acids pathway. EYP001a is a selective, synthetic FXR agonist under development for the treatment of hepatitis B.

This Phase 1 study is designed primarily to assess Pharmacokinetics (PK) under fed and fasted conditions, and to assess the safety, tolerability and Pharmacodynamics (PD) of single oral doses of EYP001a in subjects with chronic HBV infection.

Conditions

  • Hepatitis B, Chronic

Interventions

DRUG

EYP001a

Oral EYP001a capsules - 100 mg strength

Sponsors & Collaborators

  • PRA Health Sciences

    collaborator INDUSTRY

  • Enyo Pharma

    lead INDUSTRY

Principal Investigators

  • Jeroen van de Wetering, MD · PRA-EDS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2017-02-10
Primary Completion
2017-10-12
Completion
2017-10-12

Countries

  • Netherlands

Study Locations

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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 NCT03320616 on ClinicalTrials.gov