A phase 1, randomized, double-blind, placebo-controlled, escalating single- and multiple-dose study to evaluate the safety, tolerability and pharmacokinetics of EYP001a in healthy male subjects.
Completed
- Conditions
- Hepatitis Bviral infection of the liver.1001965410047438
- Registration Number
- NL-OMON42859
- Lead Sponsor
- ENYO Pharma SAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
healthy male volunteers
18 - 50 years, inclusive
weight more than 60 kilogram
BMI 18.0 - 30.0 kilogram/meter2
non smokers
Exclusion Criteria
Suffering from hepatitis B, hepatitis C, cancer or HIV/AIDS. In case of participation in another drug study within 90 days before the start of this study or being a blood donor within 60 days from the start of the study. In case of donating more than 1.5 liters of blood in the 10 months prior the start of this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary (SAD):<br /><br>To determine the safety and tolerability of single doses of EYP001a as compared<br /><br>to placebo in healthy male subjects.<br /><br>To evaluate the pharmacokinetics of single doses of EYP001a in healthy male<br /><br>subjects.<br /><br><br /><br>Primary (MAD):<br /><br>To evaluate the safety and tolerability of 14 daily doses over a period of 15<br /><br>days of EYP001a as compared to placebo in healthy male subjects.<br /><br>To evaluate the pharmacokinetics of 14 daily doses over a period of 15 days of<br /><br>EYP001a in healthy male subjects.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary (SAD & MAD):<br /><br>To evaluate the effect of EYP001a single and multiple doses on: ALT/AST, AP,<br /><br>GGT, bilirubin; apolipoprotein B (apoB), apolipoprotein A1 (apoA1),<br /><br>cholesterol, triglycerides, HDL, LDL, prothrombin time; plasma primary and<br /><br>secondary bile acids, C4 (7*-hydroxy-4- cholesten-3-one), fibroblast growth<br /><br>factor 19 (FGF19); homeostatic model assessment of insulin resistance (HomaIR)<br /><br>in MAD only.</p><br>