Actively Recruiting
Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions
Led by Enyo Pharma · Updated on 2026-02-27
40
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy male or female aged 18 to 65 years inclusive
- Females of childbearing potential must commit to using highly effective birth control
- Females not of childbearing potential must be surgically sterilized for at least 3 months or postmenopausal for at least 1 year confirmed by FSH level
- Males must commit to using adequate contraception consistently
- Negative pregnancy test for females of childbearing potential or FSH ≥ 40 IU/mL for postmenopausal females
- Non-smoker or smoker of up to 5 cigarettes daily willing to stop during the study
- Body Mass Index between 18 and 30 kg/m2 inclusive
- Considered healthy after full medical history and physical exam
- Normal blood pressure and heart rate
- Normal 12-lead ECG
- Laboratory tests within normal range including blood, chemistry, and urinalysis
- Normal dietary habits
- Signed informed consent prior to selection
- Covered by health insurance or compliant with national biomedical research laws
You will not qualify if you...
- History or presence of cardiovascular, pulmonary, gastrointestinal, hepatic, renal, metabolic, hematological, neurologic, psychiatric, systemic, or infectious disease
- Frequent headaches, migraines, recurrent nausea, or vomiting
- Symptomatic or asymptomatic postural hypotension
- Blood donation within 2 months before administration
- General anesthesia within 3 months before administration
- Drug allergy or hypersensitivity history
- Inability to avoid intense muscular effort
- Any drug use except paracetamol and contraceptives within 1 month before administration
- History or presence of drug or alcohol abuse (alcohol > 40 grams/day)
- Excessive intake of caffeine-containing beverages (> 4 cups/glasses per day)
- Positive tests for Hepatitis B, Hepatitis C, or HIV 1/2
- Positive drug abuse test
- No emergency contact possibility
- Uncooperative or non-compliant judgment by investigator
- Participation in a previous study exclusion period
- Under administrative or legal supervision
- Received more than 6,000 euros in biomedical research payments in past 12 months including this study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Eurofins Optimed
Gières, France
Actively Recruiting
Research Team
C
Clinical project manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
7
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