Unique ID issued by UMIN | UMIN000025627 |
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Receipt number | R000029485 |
Scientific Title | A pharmacokinetic study of sodium phenylbutyrate in urea cycle disorder |
Date of disclosure of the study information | 2017/01/11 |
Last modified on | 2021/12/03 00:27:52 |
A pharmacokinetic study of sodium phenylbutyrate in urea cycle disorder
A pharmacokinetic study of sodium phenylbutyrate in urea cycle disorder
A pharmacokinetic study of sodium phenylbutyrate in urea cycle disorder
A pharmacokinetic study of sodium phenylbutyrate in urea cycle disorder
Japan |
urea cycle disorder
Pediatrics |
Others
NO
To clarify pharmacokinetic properties of sodium phenylbutyrate and its metabolites in urea cycle disorder
Pharmacokinetics
Exploratory
Explanatory
Phase I
To determine concentration of phenylbutylate and its metabolites in blood and urine after oral administration of sodium phenylbutyrate
1) Plasma amino acid fraction (isoleucine, glutamine, glutamic acid, argineine), and anmonia
2) Adverse events
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
To administer sodium phenylbutylate orally at less than 200mg/kg.
6 | months-old | <= |
Not applicable |
Male and Female
1) Subjects with diagnosis of urea cycle disorder.
2) Hospitalised patients.
3) Those who can intake medicine orally.
4) Those who can receive the observation essential for this study.
5) Subjects who have been determined eligible by principal investigator or sub-investigator from physical and clinical examinations.
6) Those who have agreed with participating in this study by written informed consent prior to the study (patients or legally acceptable representative).
1) Those who have hypersensitivity with phenylbutylate, its metabolites, drug additives and/or benzoate, etc
2) Subjects with congestive heart failure, kidney failure, and/or hypernatremia with edema
3) Subjects with renal dysfunction
4) Subjects with liver cirrhosis
5) Subjects who have been determined ineligible by principal investigator or sub-investigator
10
1st name | Kei |
Middle name | |
Last name | Minowa |
Juntendo University, Faculty of Medicine
Department of Pediatrics
113-8421
2-1-1, Hongo, Bunkyo-ward, Tokyo
03-3813-3111
kminowa@juntendo.ac.jp
1st name | Kei |
Middle name | |
Last name | Minowa |
Juntendo University, Faculty of Medicine
Department of Pediatrics
113-8421
2-1-1, Hongo, Bunkyo-ward, Tokyo
03-3813-3111
kminowa@juntendo.ac.jp
Juntendo University
Japan Agency for Medical Research and Development
Government offices of other countries
Japan
GCP center, Juntendo University Hospital
3-1-3, Hongo, Bunkyo-ward, Tokyo
03-3813-3111
kenkyu5858@juntendo.ac.jp
NO
順天堂大学医学部附属順天堂医院(東京都)、神栖済生会病院(茨城県)、東京大学 大学院薬学系研究科 分子薬物動態学教室(東京都)、千葉こども病院(千葉県)、藤田保健衛生大学病院(愛知県)、大阪大学医学部附属病院(大阪府)、済生会横浜市東部病院(神奈川県)
2017 | Year | 01 | Month | 11 | Day |
Published
5
Completed
2017 | Year | 01 | Month | 06 | Day |
2017 | Year | 01 | Month | 04 | Day |
2017 | Year | 01 | Month | 11 | Day |
2021 | Year | 12 | Month | 02 | Day |
2017 | Year | 01 | Month | 11 | Day |
2021 | Year | 12 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029485
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