A Phase 1 Study to Compare the Pharmacokinetics of Vonafexor Acid and Its Lysine Salt (EYP651) and Evaluate Potential Drug-Drug Interactions in Healthy Volunteers and Patients with Impaired Renal Function or MASH

The primary objective is to perform a pharmacokinetic comparison between vonafexor acid and its lysine salt, identified as EYP651. This evaluation is clinically relevant to determine the comparative absorption and disposition profiles of the different salt forms of the compound. Secondary objectives include the assessment of potential drug-drug interactions.

The sponsor did not provide information regarding the total number of participants. The study population consists of healthy volunteers, including individuals with impaired renal function and suspected metabolic dysfunction-associated steatohepatitis. The cohort includes both males and females within the age range defined by code 3.

This Phase 1 clinical trial is designed as a pharmacokinetic comparison between vonafexor acid and its lysine salt, identified as EYP651, alongside an evaluation of potential drug-drug interactions. The study involves healthy volunteers, individuals with impaired renal function, and subjects with suspected metabolic dysfunction-associated steatohepatitis. The research methodology includes a screening visit to assess eligibility, followed by scheduled study visits to monitor drug metabolism and safety. The trial concludes with an end-of-study visit. The overall duration of the study is estimated to be approximately one year. Conditions leading to early termination from the study are not specified.

The clinical trial is designed to evaluate efficacy in subjects with impaired renal function and suspected metabolic dysfunction-associated steatohepatitis. Information regarding specific efficacy endpoints, assessment methods, or measurement schedules is not provided.