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

EicOsis Human Health Inc.1 site in 1 country18 target enrollmentApril 30, 2021

ConditionsHealthy Adults

InterventionsEC5026 oral tablet Placebo oral tablet

DrugsEC5026 oral tablet

Overview

Phase: Phase 1
Intervention: EC5026 oral tablet
Conditions: Healthy Adults
Sponsor: EicOsis Human Health Inc.
Enrollment: 18
Locations: 1
Primary Endpoint: Maximum observed plasma concentration (Cmax) in response to a single 8mg EC5026 oral tablet [Plasma Pharmacokinetics].
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

April 30, 2021

End Date

November 24, 2021

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

EicOsis Human Health Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Each subject must meet all of the following criteria to be enrolled in this study:
•Males or females must be 18-70 years of age.
•Subjects must be willing to provide written informed consent to participate in the study.
•Subjects must be in generally good health as determined by prestudy medical history, physical examination, clinical laboratory tests, and 12-lead electrocardiogram (ECG).
•Subjects must be willing to remain in confinement at the CRU for up to 4 consecutive days in 2 separate dosing periods and to return to the unit as specified for additional blood tests and safety evaluations during the study period.
•Subjects must have a body mass index of 19-32 kg/m
•Subjects must have a normal blood pressure (systolic blood pressure 90-140 mm Hg, diastolic blood pressure 50-90 mm Hg) and heart rate (resting heart rate 45-90 beats per minute) without medication. Blood pressure and heart rate may be repeated at the discretion of the investigator. If the value continues to be out of range but not clinically significant, the subject may continue per the discretion of the investigator.
•Subjects must have a clinical chemistry profile, including electrolytes, alkaline phosphatase (ALP), lactate dehydrogenase, creatine phosphokinase (CPK), creatinine, and urea, within the normal range without medication at screening. Subjects who have mildly out of range laboratory results that are not considered clinically significant by the investigator can be included in the study.
•Subjects must have an early morning (collected between 0600 AM and 0800 AM) serum cortisol level \>10 mcg/dL (\>275.9 nmol/L) and early morning adrenocorticotropic hormone (ACTH) and aldosterone levels within the normal range at screening.
•Subjects must be nonsmokers or willing to abstain from smoking 2 weeks prior to randomization and for the duration of the study.

Exclusion Criteria

•Subjects meeting any of the following criteria will be excluded from the study:
•Subjects with any abnormalities in any of the following: liver function tests, CPK, or urinalysis results. Liver function tests, CPK, or urinalysis tests may be repeated at the discretion of the investigator, if necessary, to confirm any abnormalities. Subjects who have mildly out of range CPK or urinalysis results that are not considered clinically significant by the investigator can be included in the study.
•Subjects who have used any nonstudy medication(s), including low-dose aspirin for cardiovascular prophylaxis, within 1 week before administration of study drug. This includes any drug that can confound the results of the food-effect study, such as drugs that can alter the absorption of other drugs by affecting gastrointestinal motility or by changing the gastric pH, as well as drugs that can increase or decrease the metabolism and excretion of other drugs.
•Subjects who have used chemotherapy agents or who have a history of cancer, other than nonmetastatic skin cancer that has been completely excised, within 5 years prior to screening.
•Subjects with a history of bacterial, fungal, or viral infection requiring treatment with antibiotics, antifungal agents, or antivirals within 1 month prior to randomization.
•Subjects with a history of disorders of the hypothalamic-pituitary-adrenal (HPA) or hypothalamic-pituitary-gonadal (HPG) axis.
•Subjects with a presence or history of peripheral edema within the past 5 years.
•Subjects with a history of congestive heart failure.
•Subjects who have used (within 30 days of randomization) or plan on using any of the following during the duration of the study
•any prescription or over-the-counter drugs that are cytochrome P450 (CYP) inducers or inhibitors (e.g., cimetidine, paroxetine, fluoxetine, haloperidol, ketoconazole, itraconazole, fluconazole, erythromycin, or clarithromycin)

Arms & Interventions

EC5026

Single 8 mg oral dose of EC5026

Intervention: EC5026 oral tablet

Placebo

Single dose of matching oral placebo

Intervention: Placebo oral tablet

Outcomes

Primary Outcomes

Maximum observed plasma concentration (Cmax) in response to a single 8mg EC5026 oral tablet [Plasma Pharmacokinetics].

Time Frame: 14 days