NCT03469583

Drug Drug Interaction Study for EYP001 With Entecavir

Study of the Drug Interaction of EYP001a With Entecavir in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Enyo Pharma · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of EYP100a combined with ETV in healthy men and women dosed in the morning under fasted conditions.

Detailed description

This is a Phase 1, single-center, open-label, three consecutive dosing periods study to evaluate the drug-drug interaction, PK, safety, tolerability and PD of a single dose of EYP100a combined with ETV in healthy men and women. Sixteen (16) adult male and female healthy participants 18 to 60 years of age inclusive are planned to participate in the study. Women of childbearing potential will be eligible to participate if she is non pregnant or non lactating and willing to use adequate contraception. All participants in the study will be monitored for safety after administration of the last dose of investigational product and with a follow up visit. The DDI, PK, PD, safety and tolerability of EYP001a and ETV will be assessed based on plasma-concentration profiles of EYP001a and ETV, FXR related PD markers and the types and frequency of treatment-emergent adverse events (TEAEs) reported, concomitant medication usage, and changes from baseline in physical examination (PE), vital signs, electrocardiogram (ECG), and standard clinical laboratory tests.

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
DRUG	EYP001	EYP001 self administered capsules, morning, with non carbonated water
DRUG	Entecavir 1 MG	Entecavir self administered tablets, morning, with non carbonated water

Timeline

• Start date: 2018-02-12
• Primary completion: 2018-06-20
• Completion: 2018-07-20
• First posted: 2018-03-19
• Last updated: 2018-07-26

Locations

1 site across 1 country: Australia