Pharmacokinetic Comparison of Vonafexor Acid and Its Lysine Salt and Evaluation of Potential Drug-Drug Interactions
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorEnyo Pharma
About this trial
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.
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- EYP651/Vonafexor low dose
- EYP651/Vonafexor high dose
- EYP651/CYP3A4 inhibitor
- EYP651/Transporter substrate
- EYP651/CYP2C8 and CYP2C9 substrate
Treatment groups
40 Participants
are divided into 7 treatment groups7
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Source ClinicalTrials.gov