A Phase 1 Clinical Study of E6130 -Clinical Pharmacology Study in Healthy Adult Male Subjects
- Conditions
- Healthy Adult Subjects
- Registration Number
- JPRN-jRCT2080223723
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Male
- Target Recruitment
- 44
Main Inclusion Criteria
(1) Japanese or Caucasian 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.
Main Exclusion Criteria
(1) History of surgical treatment 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method