JPRN-jRCT2051220112
Completed
Phase 2
A Phase II Study to Evaluate the Pharmacokinetics and Safety of MR19A13A in Pediatric Patients.
obuyo Oya0 sites12 target enrollmentOctober 27, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- obuyo Oya
- Enrollment
- 12
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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.
Exclusion 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.
Outcomes
Primary Outcomes
Not specified
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