A phase I, 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.
Completed
- Conditions
- Hepatitis Bviral infection of the liver10019654
- Registration Number
- NL-OMON45541
- Lead Sponsor
- ENYO Pharma SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14
Inclusion Criteria
- Has documented chronic HBV infection
- Gender : male or female
- Age : 18-65 years, inclusive, at screening
- Body mass index (BMI) : 17.0-35.0 kg/m2 inclusive, at screening
Exclusion Criteria
Suffering from hepatitis C, cancer or HIV/AIDS. Previous participation in the current study. In case of donating more than 100 milliliters of blood in the 60 days prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Pharmacokinetics:<br /><br>- Plasma EYP001a concentrations<br /><br>- Plasma PK parameters estimated using non compartmental analysis, as<br /><br>appropriate: Cmax, tmax, tlag, kel, t*, AUC0-24, AUC0-t, AUC0-inf and tlast</p><br>
- Secondary Outcome Measures
Name Time Method