NCT03320616

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

A Phase 1, Open-Label, Randomized, 4-Way Crossover Study in Subjects With Chronic Hepatitis B Virus Infection to Assess Pharmacokinetics (Fasted/Fed), Safety, Tolerability and Pharmacodynamics of Single Oral Doses of Farnesoid X Receptor Agonist EYP001a

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Enyo Pharma · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-center, open-label, randomized, 4-way crossover study. A total of 14 chronic HBV subjects will participate. Subjects will receive 4 single dose administrations of EYP001a during the study. There will be 2 separate dosing periods: 1 period with 2 single administrations of EYP001a in the morning, once under fasted conditions and once under fed condition (separated by 48.5 hours), and 1 period with 2 single administrations of EYP001a in the evening, once under fasted conditions and once under fed condition (separated by 48.5 hours). The subjects will be randomized to 1 of 4 treatment sequences: * Sequence 1: Period 1 first dose morning fasted, second dose morning fed; Period 2 first dose evening fasted, second dose evening fed. * Sequence 2: Period 1 first dose evening fasted, second dose evening fed; Period 2 first dose morning fasted, second dose morning fed. * Sequence 3: Period 1 first dose morning fed, second dose morning fasted; Period 2 first dose evening fed, second dose evening fasted. * Sequence 4: Period 1 first dose evening fed, second dose evening fasted; Period 2 first dose morning fed, second dose morning fasted. Participation will include an eligibility screening period of maximally 40 days, clinic stay during the treatment periods, and a followup visit 4 to 6 days after the last study drug administration. The safety and tolerability of EYP001a will be assessed by evaluating vital signs, ECGs, liver ultrasound, clinical laboratory and adverse events.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	EYP001a	Oral EYP001a capsules - 100 mg strength

Timeline

• Start date: 2017-02-10
• Primary completion: 2017-10-12
• Completion: 2017-10-12
• First posted: 2017-10-25
• Last updated: 2018-03-05

Locations

1 site across 1 country: Netherlands