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

ConditionHealthy Adult Male and Female Volunteers
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

This trial accepts healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

  • EYP651/Vonafexor low dose

    Drug

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

  • EYP651/Vonafexor high dose

    Drug

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

  • EYP651/CYP3A4 inhibitor

    Drug

    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

  • EYP651/Transporter substrate

    Drug

    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

  • EYP651/CYP2C8 and CYP2C9 substrate

    Drug

    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

Treatment groups

40 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Group A: Vonafexor low doseExperimental treatment 1 intervention
Group B: Vonafexor high doseExperimental treatment 1 intervention
Group C: EYP651 low doseExperimental treatment 1 intervention
Group D: EYP651 high doseExperimental treatment 4 interventions
Group E: CYP3A4 inhibitorActive comparator 1 intervention
Group F: Transporter substrateActive comparator 1 intervention
Group G: CYP2C8 and CYP2C9 substrateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part A: Pharmacokinetic Area Under the Curve (AUC)

Compare the single dose PK AUC of EYP651 and Vonafexor

Time frame
1 day
2

Part A: Pharmacokinetic Maximum Plasma Concentration (Cmax)

Compare the single dose PK Cmax of EYP651 and Vonafexor

Time frame
1 day
3

Part A: Pharmacokinetic AUC

Compare the multiple dose PK AUC of EYP651 and Vonafexor

Time frame
5 days
4

Part A: Pharmacokinetic Cmax

Compare the multiple dose PK Cmax of EYP651 and Vonafexor

Time frame
5 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Enyo Pharma

Lead sponsor

Source ClinicalTrials.gov
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