A Phase II Study of MR19A13A.

JRCT ID: jRCT2051220112

Registered date:27/10/2022

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Patients undergoing a scheduled surgery under general anesthesia.
• Date of first enrollment: 10/01/2023
• Target sample size: 12
• Study type: Interventional
• Intervention(s): MR19A13A is administered orally in one swallowing motion as possible.

Outcome(s)

Primary Outcome

Pharmacokinetics
1) Plasma concentration and Pharmacokinetic parameters of unchanged MR19A13A and its metabolites.

Safety
1) Adverse events and adverse reaction
2) Laboratory tests
3) Vital signs
systolic blood pressure, diastolic blood pressure, pulse rate
4) SpO2, respiratory rate
5) electrocardiogram

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 16age old
• Gender: Both

Include criteria

1) Japanese Patients aged from 6 months to 16 years, at the time of informed consent.
2) Patients with written consent from their legal representatives; If the patient is over 7 years, it is desirable to obtain the assent also from the patient as possible.

Exclude criteria

1) Patients with the history of hypersensitivity or suspected hypersensitivity to any ingredients of the study drug.
2) Patients with acute angle-closure glaucoma.
3) Patients with myasthenia gravis.
4) Patients receiving the drug containing HIV protease inhibitors, efavirenz, or cobicistat.
5) Patients receiving St. John's wort supplement and are unable to discontinue taking the supplement from 1 week prior to the start of study drug administration up to 8 hours after the completion of study drug administration.
6) Patients with shock, coma, or acute alcohol intoxication with suppressed vital signs.
7) Patients with severe hepatic, renal, cardiovascular, gastrointestinal, or hematological disorders.
8) Patients using or expected to use artificial heart-lungs during the surgery.
9) Patients expected to receive blood transfusion during or after the surgery (up to 8 hours after completion of the study drug administration)
10) Patients with airway problems, such as upper airway stenosis including tonsillar hypertrophy, difficult airways, etc.
11) Patients with respiratory function disorder, such as lung disease, scoliosis, etc.

Related Information

• Primary Sponsor: Nobuyo Oya