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

NCT07251153 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-02-27

No results posted yet for this study

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.

Conditions

  • Healthy Adult Male and Female Volunteers

Interventions

DRUG

EYP651/Vonafexor low dose

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at low dose according to period 1

DRUG

EYP651/Vonafexor high dose

Repeated daily dosing with EYP651 or Vonafexor Acid for 5 days, cross-over at high dose according to period 1

DRUG

EYP651/CYP3A4 inhibitor

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

DRUG

EYP651/Transporter substrate

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

DRUG

EYP651/CYP2C8 and CYP2C9 substrate

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

Sponsors & Collaborators

  • Enyo Pharma

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-28
Primary Completion
2025-12-18
Completion
2026-10-28

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07251153 on ClinicalTrials.gov