drugset / Trial / NCT03320616

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

NCT03320616

Phase 1 Completed 11 enrolled Enyo Pharma PRA Health Sciences · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject EYP001a Unknown 100 mg Oral