Phase I Clinical Trial of EA4017: Clinical Pharmacology Study in Healthy Adult Male Subjects
- Conditions
- Healthy adult subjects
- Registration Number
- JPRN-jRCT2080224789
- Lead Sponsor
- EA Pharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- Male
- Target Recruitment
- 160
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Adverse events, laboratory values, vital signs, electrocardiogram findings, physical findings
- Secondary Outcome Measures
Name Time Method pharmacokinetics<br>Plasma concentration of EA4017, urinary excretion level of EA4017, pharmacokinetics parameter of EA4017