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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    196
  • sponsor
    EA Pharma Co., Ltd.
Updated on 4 October 2022
body mass index
Accepts healthy volunteers

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.

Description

The drug being tested in this study is called EA1080. EA1080 is being tested to find a safe and well-tolerated dose in healthy Caucasian and Japanese male participants. The study consists of 2 parts as mentioned below:

Part A: This part of the study is fully adaptive and will be performed in three sub-parts as

follows
  • Single ascending dose (SAD)
  • Food Effect (FE) and optional bioavailability
  • Multiple ascending dose (MAD)

Part B: This part of study is comprised of four sub-parts to assess Formulation E and Formulation F as follows:

  • SAD
  • An additional FE period in SAD cohorts (SAD-FE)
  • Food Effect and bioavailability (FE/BA)
  • MAD

Details
Condition Healthy Volunteers
Treatment Placebo, EA1080, EA1080-matching placebo
Clinical Study IdentifierNCT04223960
SponsorEA Pharma Co., Ltd.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants must meet all of the following criteria to be eligible for enrolment in this
study
Participants in Caucasian cohorts must be healthy males, aged greater than or equal
(>=) 18 to less than or equal to (<=) 45 years at the date of signing informed consent
Participants in Japanese cohorts must be healthy males, aged >=20 to <=45 years at the
date of signing informed consent
Participants must have a body mass index (BMI) between 18.5-25.0 kilogram per square
meter (kg/m^2) inclusive at screening, Day -2 or Day -1

Exclusion Criteria

Participants will be excluded from enrolment in this study if they meet any of the
following criteria
Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab)
or human immunodeficiency virus antibody (HIV Ab) at screening
Consumption of herbal remedies or dietary supplements containing St. John's Wort 30
days before the first day of dosing
Has donated or lost 400 milliliter (mL) blood or more within the last 16 weeks
preceding the first day of dosing
An inability to follow a standardised diet and meal schedule or inability to fast, as
required during the study
Prior screen failure (where the cause of the screen failure is not deemed to be
temporary), randomisation, participation, or enrolment in this study. Participants who
initially failed due to temporary non-medically significant issues are eligible for
re-screening once the cause has resolved
Participants with veins on either arm that are unsuitable for intravenous puncture or
cannulation (example, veins that are difficult to locate, or a tendency to rupture
during puncture)
Participants with any medical condition which may cause raised intracranial pressure
participants with new or changing headaches, and participants with history of head or
spinal trauma
An absolute lymphocyte count below 0.910^9 per liter (/L) at screening or on Day -1
Participants in receipt of any vaccination for Corona virus disease (COVID-19) within
days prior to the first dose administration
History of COVID-19 polymerase chain reaction (PCR) positivity within 3 months of Day
suspected COVID-19 based on clinical presentation within 3 months of Day 1, or
presence of clinically relevant long term sequelae of COVID-19
Unwillingness to receive COVID-19 testing per local or site COVID-19 guidance
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

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