Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-28

Study Completion Date

2026-10-28

Brief Summary

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The purpose of this study is to define and compare the pharmacokinetic (PK) and pharmacodynamic (PD) profile of EYP651 at two dose levels and compare it with Vonafexor Acid PK and PD profile, the Part A.

In addition, Part B of the trial will assess the Drug-Drug Interactions (DDI) potential with the high dose of EYP651.

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Detailed Description

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The two parts are open-label and randomized, with a 2 periods, cross-over design for part A and a 3-period-parallel-arm design for Part B.

Expected duration for part A is approximately 8 weeks and Part B is approximately 12 weeks for each participating subject.

Conditions

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Healthy Adult Male and Female Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Crossover study model for the part A of the study. Parallel study model for the part B of the study

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Vonafexor low dose

Vonafexor low dose 1 tablet per day

Group Type EXPERIMENTAL

EYP651/Vonafexor low dose

Intervention Type DRUG

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1

Vonafexor high dose

Vonafexor high dose 1 tablet per day

Group Type EXPERIMENTAL

EYP651/Vonafexor high dose

Intervention Type DRUG

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1

EYP651 low dose

EYP651 low dose 1 tablet per day

Group Type EXPERIMENTAL

EYP651/Vonafexor low dose

Intervention Type DRUG

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1

EYP651 high dose

Vonafexor high dose 1 tablet per day

Group Type EXPERIMENTAL

EYP651/Vonafexor high dose

Intervention Type DRUG

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1

EYP651/CYP3A4 inhibitor

Intervention Type DRUG

Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 1 (CYP3A4 inhibitor) in period 3. Parallel group 1

EYP651/Transporter substrate

Intervention Type DRUG

Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 2 (Transporter substrate) in period 3. Parallel group 2

EYP651/CYP2C8 and CYP2C9 substrate

Intervention Type DRUG

Repeated daily dosing with EYP651 alone in period 1, Repeated daily dosing with the index drug 3 alone in period 2 and combined administration repeated daily dosing of EYP651 with index drug 3 (CYP2C8 and CYP2C9 substrate) in period 3. Parallel group 3

CYP3A4 inhibitor

Oral daily administration

Group Type ACTIVE_COMPARATOR

EYP651/CYP3A4 inhibitor

Intervention Type DRUG

Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 1 (CYP3A4 inhibitor) in period 3. Parallel group 1

Transporter substrate

Oral daily administration

Group Type ACTIVE_COMPARATOR

EYP651/Transporter substrate

Intervention Type DRUG

Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 2 (Transporter substrate) in period 3. Parallel group 2

CYP2C8 and CYP2C9 substrate

Oral daily administration

Group Type ACTIVE_COMPARATOR

EYP651/CYP2C8 and CYP2C9 substrate

Intervention Type DRUG

Repeated daily dosing with EYP651 alone in period 1, Repeated daily dosing with the index drug 3 alone in period 2 and combined administration repeated daily dosing of EYP651 with index drug 3 (CYP2C8 and CYP2C9 substrate) in period 3. Parallel group 3

Interventions

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EYP651/Vonafexor low dose

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1

Intervention Type DRUG

EYP651/Vonafexor high dose

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1

Intervention Type DRUG

EYP651/CYP3A4 inhibitor

Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 1 (CYP3A4 inhibitor) in period 3. Parallel group 1

Intervention Type DRUG

EYP651/Transporter substrate

Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 2 (Transporter substrate) in period 3. Parallel group 2

Intervention Type DRUG

EYP651/CYP2C8 and CYP2C9 substrate

Repeated daily dosing with EYP651 alone in period 1, Repeated daily dosing with the index drug 3 alone in period 2 and combined administration repeated daily dosing of EYP651 with index drug 3 (CYP2C8 and CYP2C9 substrate) in period 3. Parallel group 3

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female subject, aged 18-65 years inclusive.
* Females of childbearing potential: commitment to use a highly effective method of birth control which result in a low failure rate.

Females of non-childbearing potential: either at least 3 months surgically sterilized or at least 1-year postmenopausal confirmed by the follicle stimulating hormone (FSH) level.

Males: commitment to use an adequate contraceptive method consistently and correctly.

* Negative pregnancy test for childbearing potential women or FSH ≥ 40 IU/mL for postmenopausal women.
* Non-smoker subject or smoker of maximum 5 cigarettes a day and able to stop during the study.
* Body Mass Index (BMI) between 18 and 30 kg/m2 inclusive.
* Considered as healthy after a comprehensive clinical assessment (detailed medical history and complete physical examination).
* Normal Blood Pressure and Heart Rate.
* Normal ECG recording on a 12-lead ECG.
* Laboratory parameters within the normal range of the laboratory (hematology, hemostasis, blood chemistry tests, urinalysis).
* Normal dietary habits.
* Signing a written informed consent prior to selection.
* Covered by Health Insurance System and / or in compliance with the recommendations of National Law in force relating to biomedical research.

Exclusion Criteria

* Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric, systemic or infectious disease.
* Frequent headaches and / or migraine, recurrent nausea and / or vomiting.
* Symptomatic hypotension whatever the decrease of blood pressure or asymptomatic postural hypotension.
* Blood donation in the 2 months before administration.
* General anaesthesia in the 3 months before administration.
* Presence or history of drug allergic condition and/or hypersensitivity.
* Inability to abstain from intense muscular effort.
* Any drug intake (except paracetamol and contraceptives) during the month prior to the first administration.
* History or presence of drug or alcohol abuse (alcohol consumption \> 40 grams / day).
* Excessive consumption of beverages with xanthine bases (\> 4 cups or glasses / day).
* Positive Hepatitis B surface antigen or anti Hepatitis C Virus antibody, or positive results for Human Immunodeficiency Virus 1 or 2 tests.
* Positive results for drugs of abuse tests.
* No possibility of contact subject in case of emergency.
* Subject who, in the judgment of the Investigator, is likely to be non-compliant or uncooperative during the study, or unable to cooperate because of a language problem, poor mental development.
* Exclusion period of a previous study.
* Administrative or legal supervision.
* Subject who would receive more than 6'000 euros as indemnities for his participation in biomedical research within the 12 last months, including the indemnities for the present study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes