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.

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. - EYP001 study in subjects with chronic hepatitis B virus (HBV) infection

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45541

Enrollment

Registered

2017-01-04

Start date

2018-01-23

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis B Hepatitis B viral infection of the liver

Interventions

The study will consist of 2 periods during each of which the volunteer will be administered 2 single doses of 300 milligrams (mg) EYP001a. Thus the volunteer will receive a total of 4 single doses o

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: - Plasma EYP001a concentrations - Plasma PK parameters estimated using non compartmental analysis, as appropriate: Cmax, tmax, tlag, kel, t*, AUC0-24, AUC0-t, AUC0-inf and tlast	—

Secondary

Measure	Time frame
Safety: - Adverse events (AEs), clinical laboratory, vital signs, 12-lead electrocardiogram (ECG), liver ultrasound Pharmacodynamics: Bile metabolism related: plasma levels of total bile acids; chenodeoxycholic acid (CDCA), deoxycholic acid (DCA) and lithocholic acid (LCA); primary and secondary bile acids; bile acid precursor C4 (7a hydroxy-4-cholesten-3-one) and bile regulating fibroblast growth factor 19 (FGF-19); plasma levels of FXR mRNA profile HBV virology related: Quantitative levels of hepatitis B surface antigen (HBsAg), hepatitis Be antigen (HBeAg), HBV DNA and HBV RNA; levels of hepatitis Be antibody (anti HBe) and hepatitis B surface antibodies (anti-HBs) Glucose and lipid metabolism related: homeostatic model assessment of insulin resistance (HOMA-IR), β cell function (HOMA-%B) and insulin sensitivity (HOMA-%S); lipid panel: cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, apolipoprotein (Apo) A1 and ApoB	—

Measure

Time frame

Safety: - Adverse events (AEs), clinical laboratory, vital signs, 12-lead electrocardiogram (ECG), liver ultrasound Pharmacodynamics: Bile metabolism related: plasma levels of total bile acids; chenodeoxycholic acid (CDCA), deoxycholic acid (DCA) and lithocholic acid (LCA); primary and secondary bile acids; bile acid precursor C4 (7a hydroxy-4-cholesten-3-one) and bile regulating fibroblast growth factor 19 (FGF-19); plasma levels of FXR mRNA profile HBV virology related: Quantitative levels of hepatitis B surface antigen (HBsAg), hepatitis Be antigen (HBeAg), HBV DNA and HBV RNA; levels of hepatitis Be antibody (anti HBe) and hepatitis B surface antibodies (anti-HBs) Glucose and lipid metabolism related: homeostatic model assessment of insulin resistance (HOMA-IR), β cell function (HOMA-%B) and insulin sensitivity (HOMA-%S); lipid panel: cholesterol, triglycerides, high density lipoprotein (HDL) cholesterol, low density lipoprotein (LDL) cholesterol, apolipoprotein (Apo) A1 and ApoB

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)