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New treatment option for Healthy Adult Male and Female Volunteers
Official title Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions
ClinicalTrials.gov ID: NCT07251153
What this study is testing
What is EYP651/Vonafexor low dose?
EYP651/Vonafexor low dose is an investigational medicine, given as an once-daily, being studied as a potential treatment for healthy adult male and female volunteers.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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.
You likely can't join if
- Any relevant history or presence of cardiovascular, pulmonary, gastro-intestinal, hepatic, renal, metabolic, haematological, neurologic, psychiatric...
- 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.
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Gières, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gières, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.