ME-401 Clinical Pharmacology Study (Investigation of the Food Effect on the Pharmacokinetics of ME-401 in Healthy Japanese Adults)

JRCT ID: jRCT2071200064

Registered date:10/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Japanese healthy adult males
• Date of first enrollment: 16/11/2020
• Target sample size: 24
• Study type: Interventional
• Intervention(s): Food effect on the pharmacokinetics of ME-401 will be evaluated by using the crossover method of 2 groups x 2 periods. One capsule (60 mg/capsule) of the final formulation of ME-401 is administered in an open-label manner.

Outcome(s)

Primary Outcome

Pharmacokinetic
- Ratios of geometric mean values of Cmax, AUC0-t, AUC0-inf between fed state and fasted state

Secondary Outcome

- Pharmacokinetic
- Pharmacokinetic parameters
- Plasma ME-401 concentrations
- Safety
- Adverse events
- Laboratory test values
- Vital signs
- Standard 12-lead electrocardiograms

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 40age old
• Gender: Male

Include 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)

Exclude 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

Related Information

• Primary Sponsor: Eto Takashi