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

NCT04908995 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2024-02-20

No results posted yet for this study

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.

Conditions

  • Healthy Adults

Interventions

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.

Sponsors & Collaborators

  • EicOsis Human Health Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2021-05-12
Completion
2021-11-24
FDA Drug
Yes

Countries

  • United States

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 NCT04908995 on ClinicalTrials.gov