A phase I study of M875(single-dose study and food-effect study)

JRCT ID: jRCT2071240065

Registered date:02/10/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Oral lichen planus
• Date of first enrollment: 21/10/2024
• Target sample size: 46
• Study type: Interventional

Intervention(s)

Single-dose study:Drug administration
Single oral dose of actual drug (M875T2 or M875T3) or placebo (M875T4) with 200 mL of water after fasting for at least 10 hours.
Food-effect study:Drug administration
Fasting: Single oral dose of M875T3 with 200 mL of water after fasting for at least 10 hours.
Postprandial dose: A single oral dose of the actual drug (M875T3) with 200 mL of water within 10 minutes after a high-fat meal consumed within 20 minutes.

Outcome(s)

• Primary Outcome: Pharmacokinetics and safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 45age old
• Gender: Male

Include criteria

(1)Japanese healthy adult male aged 20 or older and younger than 45 years at the time of signing informed consent.
(2) Persons who weighs between 50 kg and 80 kg.
(3)Body mass index(BMI) (Weight (kg)/(Height (m))2)between 18.5 and 25.0 (rounded down to the second decimal place)
(4)Persons who are judged by the principal investigator, etc. to be eligible as subjects for this study, taking into consideration the results of the screening test.
(5)Persons who are able to undergo the medical examinations and tests specified in the study protocol and report subjective symptoms, etc., in accordance with the compliance requirements during participation in the clinical trial.

Exclude criteria

(1)Persons with gastrointestinal, heart, liver, kidney, blood, or other diseases that may affect pharmacokinetics and safety, or with a history of such diseases.
(2)Persons with an ALT greater than 45 U/L on the screening test.
(3)Persons with WPW syndrome, complete right bundle branch block, or Brugada syndrome determined by 12-lead ECG in the screening test(including automatic device determination).
(4)Persons with a history of major surgery in the gastrointestinal tract area, such as gastrectomy, gastrointestinal suture, or intestinal resection (appendicectomy and inguinal hernia repair are acceptable).
(5)Persons with drug hypersensitivity or allergy to drugs.
(6)Alcohol or drug dependent persons.
(7)Received cephalantin within 12 weeks prior to study drug administration.
(8)Persons who participated in another clinical trial and received another investigational drug within 12 weeks prior to the administration of the investigational drug (in case of clinical trials of health food products, this is defined as within 4 weeks prior to the administration of the investigational drug).
(9)Persons from whom at least 200 mL or 400 mL of blood samples (e.g., blood donation) had been collected within 4 or 12 weeks prior to administration of the investigational drug, or who had donated blood component within 2 weeks prior to administration of the investigational drug.
(10)Persons with a confirmed positive immunological test in the screening test.
(11)Persons who are judged to be ineligible to participate in the clinical trial by the principal investigator, etc.

Related Information

• Primary Sponsor: Fujimoto Souichi