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

JRCT ID: jRCT2071200077

Registered date:25/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: chronic graft-versus-host disease
• Date of first enrollment: 21/12/2020
• Target sample size: 66
• Study type: Interventional

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 Outcome

Safety: 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.

Key inclusion & exclusion criteria

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

Include criteria

1. 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 criteria

1. 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

• Primary Sponsor: Kijima Koji