Overview
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
Eligibility
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
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