A Clinical Pharmacology Study of MR19A13A.

JRCT ID: jRCT2031230355

Registered date:22/09/2023

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Healthy adult male
• Date of first enrollment: 21/10/2023
• Target sample size: 32
• Study type: Interventional

Intervention(s)

(Part A) Single oral administration of MR19A13A and single intravenous administration of midazolam injection are conducted with crossover method.
(Part B) MR19A13A is administered as a single oral dose.

Outcome(s)

Primary Outcome

(Pharmacokinetics)
1) Plasma concentration and Pharmacokinetic parameters of unchanged MR19A13A and 1-hydroxymidazolam
2) Bioavailability(Part A only)

(Safety)
1) Adverse events and adverse reactions
2) Laboratory tests
3) Vital signs (blood pressure, pulse rate, SpO2, EtCO2, respiratory rate, body temperature)
4) electrocardiogram

Key inclusion & exclusion criteria

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

Include criteria

1) Persons who are able to provide written informed consent prior to the start of screening examination.
2) Japanese healthy adult male volunteers who are aged 20 or over to under 40 at the time of obtaining consent.
3) Persons whose body mass index is 18.5 or over and under 25.0 at the time of screening examination.

Exclude criteria

1) Persons with, suspected of having or have a history of hypersensitivity, allergy, or idiosyncrasy to any drugs or materials used in the trial.
2) Persons with acute angle closure glaucoma.
3) Persons with myasthenia gravis.
4) Persons with a finding that may make airway management difficult.
5) Persons with a disorder on respiratory functions.
6) Persons with or have a history of a disease of gastrointestinal, heart, liver or kidney that affect drug absor.ption, distribution, metabolism and excretion.
7) Persons with a history of big surgery at gastrointestinal tract site such as gastrectomy, gastrointestinal suture, and intestinal resection.
8) Persons who had taken other drugs or supplements within 2 weeks prior to hospitalization, or who need to take other drugs or supplements by the end of the clinical trial.
9) Persons who had taken food or drink containing grapefruit within 7 days prior to hospitalization.
10) Persons who had taken alcohol within 24 hours prior to the screening examination or within 2 days prior to hospitalization.
11) Persons with a positive result on alcohol or drug abuse test at the time of screening examination or hospitalization.
12) Persons with a positive result on hepatitis B, hepatitis C, HIV or syphilis test at the time of screening examination.
13) Persons with a history of neurological or phychiatric disease that affect cognitive function.
14) Persons who had donated a 400 mL whole blood within 12 weeks, a 200 mL whole blood within 4 weeks or a component blood within 2 weeks prior to hospitalization.

Related Information

• Primary Sponsor: Nobuyo Oya