RecruitingPhase 1

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

France40 participantsStarted 2025-10-28

Plain-language summary

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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Part A: Pharmacokinetic Area Under the Curve (AUC)

Timeframe: 1 day

Part A: Pharmacokinetic Maximum Plasma Concentration (Cmax)

Timeframe: 1 day

Part A: Pharmacokinetic AUC

Timeframe: 5 days

Part A: Pharmacokinetic Cmax

Timeframe: 5 days

Part B: CYP3A4 inhibition change in AUC

Timeframe: 5 days

Part B: CYP3A4 inhibition change in Cmax

Timeframe: 5 days

Part B: Transporter sensitive substrate change in AUC

Timeframe: 5 days

Part B: Transporter sensitive substrate change in Cmax

Trial details

NCT IDNCT07251153

SponsorEnyo Pharma

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12-18

Contact for this trial

Clinical project manager

+33 (0)4 37 70 02 19 mod@enyopharma.com

View on ClinicalTrials.gov More Healthy Adult Male and Female Volunteers trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Part A: Pharmacokinetic Area Under the Curve (AUC)

Timeframe: 1 day

Part A: Pharmacokinetic Maximum Plasma Concentration (Cmax)

Timeframe: 1 day

Part A: Pharmacokinetic AUC

Timeframe: 5 days

Part A: Pharmacokinetic Cmax

Timeframe: 5 days

Part B: CYP3A4 inhibition change in AUC

Timeframe: 5 days

Part B: CYP3A4 inhibition change in Cmax

Timeframe: 5 days

Part B: Transporter sensitive substrate change in AUC

Timeframe: 5 days

Part B: Transporter sensitive substrate change in Cmax