Healthy Adult Subjects
Conditions
Interventions
investigational material(s)
Generic name etc : E6130
INN of investigational material :
Therapeutic category code : --- Other
Dosage and Administration for Investigational material : single dose
cont
Sponsors
EA Pharma Co.,Ltd.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: (1) Japanese healthy adult males aged >=20 and <45 years at the time of informed consent who are non-smokers or able to stop smoking from at least 4 weeks before study drug administration until the post-treatment examination. (2) Has voluntarily consented, in writing, to participate in this study. (3) Has been thoroughly briefed on the conditions for participation in the study, and is willing and able to comply with the conditions.
Exclusion criteria
Exclusion criteria: (1) History of surgical treatment that may affect the pharmacokinetics of the study drug at screening. (2) Suspected to have clinically abnormal symptoms or impairment of organ function requiring treatment on the basis of history and complications at screening, and physical findings, vital signs, ECG findings, or laboratory values at screening or baseline. (3) History of drug allergy at screening. (4) Judged by the investigator or subinvestigator to be inappropriate for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | — |
Outcome results
None listed