ME-401 Clinical Pharmacology Study (Investigation of the Food Effect on the Pharmacokinetics of ME-401 in Healthy Japanese Adults)
Phase 1
- Conditions
- Japanese healthy adult males
- Registration Number
- JPRN-jRCT2071200064
- Lead Sponsor
- Eto Takashi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 24
Inclusion Criteria
Personally provided written voluntary informed consent to participate in the study
- Japanese men aged >= 20 and < 40 years at the time of informed consent
- BMI >= 18.5 and < 25.0 kg/m2 at screening (the second decimal place is truncated)
Exclusion Criteria
- Current disease requiring treatment
- History of or current digestive system diseases (peptic ulcer, reflux esophagitis, etc.) excluding history of appendicitis
- Current allergic disease with symptoms or on treatment at screening
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pharmacokinetic<br> - Ratios of geometric mean values of Cmax, AUC0-t, AUC0-inf between fed state and fasted state
- Secondary Outcome Measures
Name Time Method - Pharmacokinetic<br> - Pharmacokinetic parameters<br> - Plasma ME-401 concentrations<br>- Safety<br> - Adverse events<br> - Laboratory test values<br> - Vital signs<br> - Standard 12-lead electrocardiograms