Richmond Pharmacology Ltd
London, United Kingdom
NCT Number: NCT04223960
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.
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Notify Me18 year–45 year
Male
Interventional
Phase 1
London, United Kingdom
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:
Part B: This part of study is comprised of four sub-parts to assess Formulation E and Formulation F as follows:
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participants must meet all of the following criteria to be eligible for enrolment in this study:
Exclusion criteria
Participants will be excluded from enrolment in this study if they meet any of the following criteria:
EA1080 Formulation A.
EA1080-matching placebo.
Time frame: Up to approximately 3 year 4 months
Time frame: Up to approximately 3 year 4 months
Time frame: Up to approximately 3 year 4 months
Time frame: Up to approximately 3 year 4 months
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: SAD: Pre-dose (Day 1) and up to Day 8; FE and optional BA: Pre-dose (Day 1) and up to Day 15; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 5; Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 5; Part A and B, MAD: Pre-dose (Day 1) and up to Day 25 Part A and Day 21 for Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 5; Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 5; MAD: Pre-dose (Day 1) and up to Day 25 Part A and Day 21 for Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 5; Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 5; MAD: Pre-dose (Day 1) and up to Day 25 Part A and Day 21 for Part B
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A and B, SAD: Pre-dose (Day 1) and up to Day 8; Part A, FE and Part B, SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22; MAD: Pre-dose (Day 1) and up to Day 28 Part A and up to Day 24 Part B
Time frame: Part A, FE: Pre-dose (Day 1) and up to Day 15; Part B SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22
Time frame: Part A, FE: Pre-dose (Day 1) and up to Day 15; Part B SAD and additional FE: Pre-dose (Day 1) and up to Day 15; Part B, FE/BA: Pre-dose (Day 1) and up to Day 22
EA Pharma Co., Ltd.
Industry
A First-in-human, Randomized, Double-blinded, Placebo-controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Bioavailability and Food-effects of EA1080 in Healthy Caucasian and Japanese Male Volunteers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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