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Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions | Clinical Trials | Clareo Health

RECRUITINGPHASE1

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

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

NCT07251153•Enyo Pharma

View on ClinicalTrials.gov

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.

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.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Yes

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.
+4 more criteria

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).
+7 more criteria

Locations (1)

Eurofins Optimed

Gières, France

Key Dates

Start Date

October 28, 2025

Primary Completion Date

December 18, 2025

Completion Date

October 28, 2026

Last Updated

February 27, 2026

Enrollment

ESTIMATED participants

Conditions

Healthy Adult Male and Female Volunteers

Interventions

EYP651/Vonafexor low dose

DRUG

EYP651/Vonafexor high dose

DRUG

EYP651/CYP3A4 inhibitor

DRUG

EYP651/Transporter substrate

DRUG

EYP651/CYP2C8 and CYP2C9 substrate

DRUG

Contacts

Clinical project manager

CONTACT

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

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 27, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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