NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2071200077

Registered date:25/12/2020

A Clinical Pharmacology Study of ME3208 in Healthy Japanese Male Subjects (Phase 1)

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedchronic graft-versus-host disease
Date of first enrollment21/12/2020
Target sample size66
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Part 1: In cohorts 1-3, ME3208 tablets are administered orally at a single dose of 200, 400, or 800 mg. In the placebo group, placebo tablets are administered. In cohorts 4-6, ME3208 tablets are administered orally at a dose of 200 mg QD, at a dose of 200 mg BID (morning and night), or at a dose of 400 mg QD for 7 days. In the placebo group, placebo tablets are administered. Part 2: ME3208 200 mg tablets are administered under fasting, 5 minutes after a meal or 30 minutes after a meal, respectively.

Outcome(s)

Primary OutcomeSafety: The safety and tolerability of single or multiple doses for 7 days are assessed by subjective symptoms, objective findings, physiological and clinical examinations. Pharmacokinetics: Part 1: The pharmacokinetics of single or multiple doses for 7 days are investigated by plasma ME3208 and metabolites concentrations, as well as plasma pharmacokinetic parameters. Part 2: The effect of food on the pharmacokinetics of a single dose are investigated by plasma ME3208 and metabolites concentrations, as well as plasma pharmacokinetic parameters.
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximum< 40age old
GenderMale
Include criteria1. Japanese healthy males aged 20 years or over but under 40 years at the time of signing the informed consent 2. Body mass index (BMI) = Body weight (kg) / (Height [m])^2: >=18.5 and <25.0 (at screening) 3. Subjects who exhibited no clinically abnormal findings in the judgment of the investigator or the subinvestigators at screening within 4 weeks before the first dosing, at medical observation, tests, and evaluations on the day before and pre-dose of the first dosing
Exclude criteria1. The subjects had used any medication within 7 days prior to the first dosing (except topical use not intended to systemic activity) 2. The subjects had experienced 400 mL or more of blood collection for donation or other purpose within 12 weeks prior to the first dosing, 200 mL or more of blood within 4 weeks prior to the first dosing, or donation by apheresis within 2 weeks prior to the first dosing 3. The subjects have concurrent or history of cardiac, hepatic, renal, gastrointestinal, respiratory, vascular or hematological function disorders 4. The subjects are positive for urine drug abuse tests 5. The subjects who were judged to be inappropriate to participate in the study by the investigator or the subinvestigators

Related Information

Contact

Public contact
Name Clinical Development Dept.
Address 2-4-16, Kyobashi, Chuo-ku, Tokyo Tokyo Japan 104-8002
Telephone +81-3-3273-3746
E-mail clinical-trials@meiji.com
Affiliation Meiji Seika Pharma Co.,Ltd.
Scientific contact
Name Koji Kijima
Address 2-4-16, Kyobashi, Chuo-ku, Tokyo Tokyo Japan 104-8002
Telephone +81-3-3273-3746
E-mail clinical-trials@meiji.com
Affiliation Meiji Seika Pharma Co.,Ltd.