Compare two forms and doses of vonafexor and see if the high dose interacts with other drugs
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
This test looks at how two doses and two formulations of vonafexor (EYP651 and vonafexor acid) are absorbed and processed in healthy adults and whether the high dose interacts with common medicines.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Enyo Pharma Industry-sponsored |
| Locations | 1 site (Gières) |
| Trial ID | NCT07251153 on ClinicalTrials.gov |
What this trial studies
This is an open-label Phase 1 program with two parts: Part A is a randomized two-period crossover comparing PK and PD of two dose levels and formulations (EYP651 versus vonafexor acid), and Part B is a three-period parallel-arm design testing drug–drug interactions with the high EYP651 dose. Healthy men and women aged 18–65 with BMI 18–30, normal labs, ECG, and vital signs will be enrolled under strict contraception and smoking criteria. Part A lasts about 8 weeks per participant and Part B about 12 weeks per participant. Interventions include low and high doses of EYP651/vonafexor and coadministration with a CYP3A4 inhibitor, a transporter substrate, and CYP2C8/CYP2C9 substrates to probe interaction pathways.
Who should consider this trial
Good fit: Healthy adults aged 18–65 with BMI 18–30, normal clinical exam, ECG and lab results, non- or light-smokers, and women willing to use effective contraception or who are non-childbearing.
Not a fit: People with active medical conditions, pregnant or breastfeeding women, those outside the 18–65 range, or those taking multiple chronic medications are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the results could clarify safe dosing and co-prescription guidance by showing formulation differences and any clinically important drug interactions.
How similar studies have performed: Early-phase pharmacokinetic and drug–drug interaction studies of vonafexor formulations have been performed previously, so the approach is standard though specific interaction results vary by formulation.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Gières
- Eurofins Optimed — Gières, France (Recruiting)
Study contacts
- Study coordinator: Clinical project manager
- Email: mod@enyopharma.com
- Phone: +33 (0)4 37 70 02 19
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.