Phase 1 Study Comparing Vonafexor Acid and Its Lysine Salt EYP651 in Healthy Adults Including Evaluation of Potential Drug Interactions

What this Trial Is About

Researchers are evaluating and comparing the pharmacokinetic PK and pharmacodynamic PD profiles of two forms of Vonafexor Acid the original acid and its lysine salt form called EYP651. This study includes two parts Part A focuses on comparing these profiles at two dose levels, while Part B assesses potential drug interactions with the high dose of EYP651. The trial is a Phase 1 study involving healthy adult volunteers. The study design includes two parts with different structures. Part A is an open-label, randomized, two-period crossover study lasting about 8 weeks, where participants receive low and high doses of Vonafexor or EYP651 in a crossover manner. Part B uses a three-period parallel-arm design lasting about 12 weeks, assessing drug-drug interactions by combining EYP651 with other drugs that affect liver enzymes or transporters. All treatments are given as oral tablets once daily. Participants will undergo multiple assessments including blood tests to measure drug levels and effects on liver enzymes and transporters. Safety is monitored through medical exams, ECGs, vital signs, and laboratory tests. The primary outcomes include pharmacokinetic measures such as area under the curve AUC and maximum concentration Cmax over various time points. Each participants involvement lasts approximately 8 to 12 weeks depending on the study part, with close monitoring throughout.

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