UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027674 |
|---|---|
| Receipt number | R000031699 |
| Scientific Title | A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease's therapy |
| Date of disclosure of the study information | 2017/06/07 |
| Last modified on | 2021/12/03 00:29:02 |
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Basic information
Public title
A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease's therapy
Acronym
A pharmacokinetic study of sodium phenylbutyrate in healthy adults
Scientific Title
A pharmacokinetic study of sodium phenylbutyrate in healthy adults for refractory pediatric cholestatic disease's therapy
Scientific Title:Acronym
A pharmacokinetic study of sodium phenylbutyrate in healthy adults
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify pharmacokinetic properties of sodium phenylbutyrate and its metabolites in healthy adults
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I
Assessment
Primary outcomes
To determine concentration of phenylbutylate and its metabolites in blood and urine after oral administration of sodium phenylbutyrate
Key secondary outcomes
1) Plasma amino acid fraction (isoleucine, glutamine, glutamic acid, argineine), and anmonia
2) Adverse events
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administer sodium phenylbutylate orally at less than 3.3-4.3g/m2 before meal
Interventions/Control_2
administer sodium phenylbutylate orally at less than 3.3-4.3g/m2 after meal
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Healthy adults (subjects more than 20 years old who have not experienced any serious diseases)
2) Those who can visit our institutions.
3) Those who don't need any medication at present.
4) Those who can intake medicine orally.
5) Those who can receive the observation essential for this study.
6) Those who have been determined eligible by principal investigator or sub-investigator from physical and clinical examinations.
7) Those who have agreed with participating in this study by written informed consent prior to the study.
Key exclusion criteria
1) Those who have hypersensitivity with phenylbutylate, its metabolites, drug additives and/or benzoate, etc.
2) Those who have experienced serious disease.
3) Those who have received medication in the previous two months.
4) Those who have received more than 200ml whole blood sampling in the previous 4 weeks, or blood component sampling in the previous 2 weeks.
5) Those who have received more than 400ml whole blood sampling in the previous 12 weeks.
6) Those who have been included in any phase 1 clinical trial for medicine containing new active ingredient in the previous 4 months.
7) Those who are less than 20 years old.
8) Drug addicts.
9) Alcoholics
10) Those who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Minowa |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ward, Tokyo
TEL
03-3813-3111
kminowa@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Kei |
| Middle name | |
| Last name | Minowa |
Organization
Juntendo University, Faculty of Medicine
Division name
Department of Pediatrics
Zip code
113-8421
Address
2-1-1, Hongo, Bunkyo-ward, Tokyo
TEL
03-3813-3111
Homepage URL
kminowa@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Strategic Research Promotion, Research Ethics Committee Office, Juntendo University School of Medicine
Address
3-1-3, Hongo, Bunkyo-ward, Tokyo
Tel
03-3813-3111
rinri@juntendo.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
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）、宮城県立こども病院（宮城県）、山口大学医学部附属病院（山口県）、長崎大学病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 30 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 06 | Month | 07 | Day |
Last modified on
| 2021 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031699
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