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A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability, and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Participants

NCT04223960 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 184

Last updated 2023-12-26

No results posted yet for this study

Summary

The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple ascending oral doses in healthy Caucasian and Japanese male participants.

Conditions

  • Healthy Volunteers

Interventions

DRUG

EA1080

EA1080 Formulation A.

DRUG

EA1080

EA1080 Formulation B.

DRUG

EA1080

EA1080 Formulation C.

DRUG

EA1080

EA1080 Formulation D.

DRUG

EA1080-matching placebo

EA1080-matching placebo.

DRUG

EA1080

EA1080 Formulation E.

DRUG

EA1080

EA1080 Formulation F.

Sponsors & Collaborators

  • EA Pharma Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-01-09
Primary Completion
2023-08-06
Completion
2023-08-06

Countries

  • United Kingdom

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 NCT04223960 on ClinicalTrials.gov