NCT04908995

Safety, Tolerability, Pharmacokinetics and Food Effects of Oral EC5026 in Healthy Subjects

A Single-Center, Double-Blind, Placebo-Controlled, Phase 1a, Fed-Fasted, Crossover Study To Investigate The Safety, Tolerability, Pharmacokinetics, And Food Effects Of A Single Oral Dose Of EC5026 In Healthy Male And Female Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: EicOsis Human Health Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to provide safety, tolerability, pharmacokinetics and food effects data of a single 8 mg oral dose of EC5026 in healthy subjects.

Detailed description

This is a single-center, double-blind, placebo-controlled, Phase 1a single dose study fed-fasted study evaluating the safety, tolerability, pharmacokinetics and food effects of a single 8 mg oral dose of EC5026 in healthy male and female subjects. EC5026 is an inhibitor of the soluble Epoxide Hydrolase (sEH) enzyme developed as a first-in-class analgesic for the treatment of pain. This study will help refine the dosing strategy for subsequent multiple-dose studies in healthy subjects and for future clinical trials in patients with pain. sEH is an enzyme that is downstream in the cytochrome P450 (CYP) pathway of the arachidonic acid (AA) cascade. The sEH enzyme is responsible of metabolizing a class of epoxy-fatty acids known as epoxyeicosatrienoic acids (EETs), which are potent, naturally occurring analgesics. EETs are produced at high concentrations in areas of tissue damage and inflammation, but are rapidly metabolized by the sEH enzyme into inactive compounds. Effective inhibition of sEH activity prolongs the ability of EETs to exert their analgesic activity.

Conditions

• Healthy Adults

Interventions

Type	Name	Description
DRUG	EC5026 oral tablet	12 subjects will receive a single oral 8 mg dose of EC5026 in two Dosing Periods (one in fed state and one in fasted state) separated by a Washout Period. Subjects in this group will be randomized 1:1 to one of 2 sequences: * Dosing Sequence A: Subjects will be dosed in a fed state in Dosing Period 1 and in a fasted state in Dosing Period 2, or * Dosing Sequence B: subjects will be dosed in a fasted state in Dosing Period 1 and in a fed state in Dosing Period 2.
OTHER	Placebo oral tablet	6 subjects will receive an oral dose of matching placebo in one single Dosing Period. Subjects in this group will be randomized 1:1 to receive placebo under fed or fasted conditions. Note: Subjects assigned to the placebo arm will not return for a second Dosing Period.

Timeline

• Start date: 2021-04-30
• Primary completion: 2021-05-12
• Completion: 2021-11-24
• First posted: 2021-06-01
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study