NCT03976687

Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients

A Phase 1b, Open-label Multiple Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of FXR Agonist/Modulator EYP001a in Healthy Volunteers and Nonalcoholic Steatohepatitis Patients

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Enyo Pharma · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This is a single centre, open label, randomized, 3 treatment arms, with and without food dosing, Phase 1b pharmacology study to assess the safety, tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of Farnesoid X Receptor (FXR) agonist/modulator EYP001a in healthy volunteers and Nonalcoholic Steatohepatitis (NASH) patients.

Detailed description

In total 16 participants (4 healthy volunteers and 12 NASH patients) will be enrolled and randomly assigned to one of the 3 treatment arms: * Treatment Arm 1: Dose A once daily morning dose (n=4 NASH patients, n=4 healthy volunteers) * Treatment Arm 2: Dose B once daily morning dose (n=4 NASH patients) * Treatment Arm 3: Dose C twice daily - first morning dose and second dose 3 hours post first dose (n=4 NASH patients). Subsequently, all the enrolled participants (both healthy volunteers and NASH patients) will be randomly assigned to one of the 2 parallel study Groups: * Group A (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1. Participants in Group A will be dosed in a fasted state on Days 2, 3, 4 and 5 followed by dosing in fed state on Days 6, 7, 8 and 9. * Group B (n=8, 2 healthy volunteers and 6 NASH patients): This group will include 2 NASH patients from Treatment Arms 1, 2 and 3 and 2 healthy volunteers from Treatment Arm 1. Participants in Group B will be dosed in a fed state on Days 2, 3, 4 and 5 followed by dosing in fasted state on Days 6, 7, 8 and 9. The maximum total engagement duration for eligible participants in this study is up to 76 days: 60 days screening, 1-day admission visit and 8 days dosing period (in-patient in clinical trial unit) and 7 days follow-up. The participants who are eligible for enrolment will be admitted to the Clinical Trial Unit on Day 1. The participants will receive EYP001a at the study site by trained personnel per the schedule of dosing for the study from Day 2 to Day 9 in fed/fasted state depending upon the study group. Participants will be discharged on the morning (8:00 AM) of Day 10 after collection of last PK and PD blood samples. Participants will return to the Clinical Trial Unit on Day 16 for the follow-up visit.

Conditions

• NASH - Nonalcoholic Steatohepatitis
• Healthy

Interventions

Type	Name	Description
DRUG	EYP001a	Oral tablets

Timeline

• Start date: 2019-06-11
• Primary completion: 2020-05-25
• Completion: 2020-05-25
• First posted: 2019-06-06
• Last updated: 2020-09-25

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study