NCT03272009

Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects

A Randomized, Double-blind, Placebo-controlled Study to Determine the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of the FXR-agonist EYP001a in Chronically HBV Infected Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 73 (actual)
• Sponsor: Enyo Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a multicenter, randomized, double-blind, placebo-controlled two-part trial. In Part A, EYP001a will be administered as 29 days monotherapy. Three dose-levels and 2 dosing regimens of EYP001a will be explored against placebo. The design also includes an open-label standard of care Entecavir monotherapy arm (comparator). Subjects will be randomly assigned to one of the 6 treatment arms: * Treatment A: oral EYP001a * Treatment B: oral EYP001a * Treatment C: oral EYP001a * Treatment D: oral EYP001a * Treatment E: oral placebo * Treatment F: oral Entecavir In Part B, EYP001a or placebo will be administered as 29 days combination therapy with the standard of care Peg-IFNα2a. Subjects will be randomly assigned to one of the 3 treatment arms: * Treatment G: oral EYP001a plus open label Peg-INFα2a administered as subcutaneous injection * Treatment H: oral EYP001a plus open label Peg-INFα2a administered as subcutaneous injection * Treatment I: oral placebo plus open label Peg-INFα2a administered as subcutaneous injection Subjects enrolled in Part A are eligible for participation in Part B. Participation will include a 40 day screening period, a 29 day treatment period and a 6 day follow-up evaluation period. For subjects who participate in both Parts A and B, a 14 washout period between Parts A and B will be included. The safety and tolerability of EYP001a will be assessed by evaluating physical examinations, vital signs, ECGs, clinical laboratory parameters, and adverse events.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-09-21
• Primary completion: 2018-07-30
• Completion: 2018-07-30
• First posted: 2017-09-05
• Last updated: 2018-08-21

Locations

9 sites across 4 countries: Australia, Netherlands, Poland, Thailand