Healthy Adult Male and Female VolunteersPhase 1NCT07251153
Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions
A Phase 1 study testing EYP651/Vonafexor low dose, EYP651/Vonafexor high dose and EYP651/CYP3A4 inhibitor in people with Healthy Adult Male and Female Volunteers, run by Enyo Pharma at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Male and Female Volunteers
- What is being tested?
- EYP651/Vonafexor low dose, EYP651/Vonafexor high dose and EYP651/CYP3A4 inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Oct 2025to 28 Oct 2026
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Show all 16Show fewer
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurofins Optimed
Gières
Clinical Project Manager, +33 (0)4 37 70 02 19, mod@enyopharma.com
About this study
Official title: A Phase 1, Two Parts, Open-label, Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt (EYP651) in Healthy Volunteers and Evaluation of Potential Drug-Drug Interactions
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.
Read the detailed description
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
- Healthy Adult Male and Female Volunteers
- Being tested
- EYP651/Vonafexor low dose, EYP651/Vonafexor high dose, EYP651/CYP3A4 inhibitor, EYP651/Transporter substrate, EYP651/CYP2C8 and CYP2C9 substrate
- Keywords
- Drug-Drug Interactions, Pharmacokinetic, Pharmacodynamic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EYP651/Vonafexor low doseDrug
Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1
EYP651/Vonafexor high doseDrug
Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1
EYP651/CYP3A4 inhibitorDrug
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 substrateDrug
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 substrateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Vonafexor low dose | Experimental | Vonafexor low dose 1 tablet per day Receives: Drug: EYP651/Vonafexor low dose |
| Vonafexor high dose | Experimental | Vonafexor high dose 1 tablet per day Receives: Drug: EYP651/Vonafexor high dose |
| EYP651 low dose | Experimental | EYP651 low dose 1 tablet per day Receives: Drug: EYP651/Vonafexor low dose |
| EYP651 high dose | Experimental | Vonafexor high dose 1 tablet per day Receives: Drug: EYP651/Vonafexor high dose; Drug: EYP651/CYP3A4 inhibitor; Drug: EYP651/Transporter substrate; Drug: EYP651/CYP2C8 and CYP2C9 substrate |
| CYP3A4 inhibitor | Active comparator | Oral daily administration Receives: Drug: EYP651/CYP3A4 inhibitor |
| Transporter substrate | Active comparator | Oral daily administration Receives: Drug: EYP651/Transporter substrate |
| CYP2C8 and CYP2C9 substrate | Active comparator | Oral daily administration Receives: Drug: EYP651/CYP2C8 and CYP2C9 substrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A: Pharmacokinetic Area Under the Curve (AUC)
Compare the single dose PK AUC of EYP651 and Vonafexor
Measured: 1 day
Part A: Pharmacokinetic Maximum Plasma Concentration (Cmax)
Compare the single dose PK Cmax of EYP651 and Vonafexor
Measured: 1 day
Part A: Pharmacokinetic AUC
Compare the multiple dose PK AUC of EYP651 and Vonafexor
Measured: 5 days
Part A: Pharmacokinetic Cmax
Compare the multiple dose PK Cmax of EYP651 and Vonafexor
Measured: 5 days
Part B: CYP3A4 inhibition change in AUC
To assess the effect of strong CYP3A4 inhibition on the pharmacokinetic AUC of EYP651 using Index drug 1, to evaluate EYP651 as an object of CYP3A4 inhibition
Measured: 5 days
Part B: CYP3A4 inhibition change in Cmax
To assess the effect of strong CYP3A4 inhibition on the pharmacokinetic Cmax of EYP651 using Index drug 1, to evaluate EYP651 as an object of CYP3A4 inhibition
Measured: 5 days
Part B: Transporter sensitive substrate change in AUC
To characterize the effect of EYP651 on the pharmacokinetic AUC of transporter sensitive substrate (Index drug 2) with EYP651 as the precipitant
Measured: 5 days
Part B: Transporter sensitive substrate change in Cmax
To characterize the effect of EYP651 on the pharmacokinetic Cmax of transporter sensitive substrate (Index drug 2) with EYP651 as the precipitant
Measured: 5 days
Part B: CYP2C8/CYP2C9 sensitive substrate change in AUC
To characterize the effect of EYP651 on the pharmacokinetic AUC of CYP2C8/CYP2C9 sensitive substrate (Index drug 3) with EYP651 as the precipitant
Measured: 5 days
Part B: CYP2C8/CYP2C9 sensitive substrate change in Cmax
To characterize the effect of EYP651 on the pharmacokinetic Cmax of CYP2C8/CYP2C9 sensitive substrate (Index drug 3) with EYP651 as the precipitant
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start28 Oct 2025
- Primary completion18 Dec 2025
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult Male and Female VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover study model for the part A of the study. Parallel study model for the part B of the study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Enyo Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07251153
- Sponsor's protocol ID
- EYP001-110
- Other IDs
- 2025-522915-40-00, 2025
- Status last verified
- Feb 2026
- First submitted
- 14 Nov 2025
- Last updated
- 27 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underline published results might be shared upon request with researchers who provide a methodologically sound proposal and to achieve objectives as set in the approved proposal.