NCT04223960

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: EA Pharma Co., Ltd. · Industry
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Detailed 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

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-01-09
• Primary completion: 2023-08-06
• Completion: 2023-08-06
• First posted: 2020-01-13
• Last updated: 2023-12-26

Locations

1 site across 1 country: United Kingdom