Healthy adult subjects
Conditions
Interventions
investigational material(s)
Generic name etc : EA4017
INN of investigational material : -
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : Oral
control m
Sponsors
EA Pharma Co., Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Main inclusion criteria - Non-smoking Japanese and Caucasian healthy adult males. - Body Mass Index (BMI) at screening is below. Japanese: 18.5 or more but less than 25.0 kilogram per square metre (kg/m^2) Caucasian: 18.5 or more but less than 30.0 kilogram per square metre (kg/m^2) - Written, informed consent to participate in the study based on the participant's own free will and able to comply with the requirements in the study.
Exclusion criteria
Exclusion criteria: Main exclusion criteria - With a surgical history at screening period that may affect the pharmacokinetics of the investigational product. - Suspicion of having a clinically abnormal symptom or an organ impairment that requires treatments based on the history/complications at screening period or physical findings, vital signs, electrocardiogram findings, or laboratory values at screening or baseline period. - A history of drug allergy at screening period. - Judged by the investigator or subinvestigator to be inappropriate for the participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety Adverse events, laboratory values, vital signs, electrocardiogram findings, physical findings | — |
Secondary
| Measure | Time frame |
|---|---|
| pharmacokinetics Plasma concentration of EA4017, urinary excretion level of EA4017, pharmacokinetics parameter of EA4017 | — |
Countries
Japan
Outcome results
None listed