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
Enyo Pharma
40 participants
Oct 28, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1
Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1
Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 1 (CYP3A4 inhibitor) in period 3. Parallel group 1
Repeated daily dosing with EYP651 alone in period 1, and combined administration repeated daily dosing of EYP651 with index drug 2 (Transporter substrate) in period 3. Parallel group 2
Repeated daily dosing with EYP651 alone in period 1, Repeated daily dosing with the index drug 3 alone in period 2 and combined administration repeated daily dosing of EYP651 with index drug 3 (CYP2C8 and CYP2C9 substrate) in period 3. Parallel group 3
Locations(1)
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NCT07251153