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

  • STATUS
    Recruiting
  • participants needed
    206
  • sponsor
    EA Pharma Co., Ltd.
Send
Updated on 16 February 2024
See if I qualify
body mass index

Summary

The primary purpose of the study is to evaluate the safety and tolerability of EA1080 following single and multiple 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 4 parts as mentioned below:

Part 1: Single ascending dose Formulation A:

  • Part 1A: In healthy adult Caucasian male participants
  • Part 1B: In healthy adult Japanese male participants

Part 2: Bioavailability (BA) and Food Effect (FE):

  • Part 2A: Four-way cross-over single dose (SD) in healthy adult Caucasian male participants for Formulation A and B
  • Part 2B: Two-way cross-over SD in healthy adult Japanese male participants for FE for selected formulation chosen from Part 2A

Part 3: SAD of the chosen formulation:

  • Part 3A: In healthy adult Caucasian male participants for selected formulation chosen from Part 2A
  • Part 3B: In healthy adult Japanese male participants for selected formulation chosen from Part 2A
  • Part 3C: SD of Formulation C in healthy adult Caucasian male participants

Part 4: Multiple ascending dose (MAD) of the chosen formulation:

  • Part 4A: In healthy adult Caucasian male participants for selected formulation chosen from Part 2A
  • Part 4B: In healthy adult Japanese male participants for selected formulation chosen from Part 2A

Details
Condition Healthy Volunteers
Age 18years - 45years
Treatment Placebo, EA1080
Clinical Study IdentifierNCT04223960
SponsorEA Pharma Co., Ltd.
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

b'Participants will be excluded from enrolment in this study if they meet any of the'
b'following criteria:'
b'Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab),'
b'or human immunodeficiency virus antibody (HIV Ab) at screening'
b"Consumption of herbal remedies or dietary supplements containing St. John's Wort 30"
b'days before the first day of dosing'
b'Has donated or lost 400 milliliter (mL) blood or more within the last 16 weeks'
b'preceding the first day of dosing'
b'An inability to follow a standardised diet and meal schedule or inability to fast, as'
b'required during the study'
b'Prior screen failure (where the cause of the screen failure is not deemed to be'
b'temporary), randomisation, participation, or enrolment in this study. Participants who'
b'initially failed due to temporary non-medically significant issues are eligible for'
b're-screening once the cause has resolved'
b'Participants with veins on either arm that are unsuitable for intravenous puncture or'
b'cannulation (example, veins that are difficult to locate, or a tendency to rupture'
b'during puncture)'
b'Participants with any medical condition which may cause raised intracranial pressure,'
b'participants with new or changing headaches, and participants with history of head or'
b'pinal trauma'
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Email

View email

Phone

Phone country flag

View phone
Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

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

Similar trials to consider

Browse trials for

body mass index

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.