UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047118 |
|---|---|
| Receipt number | R000053747 |
| Scientific Title | The effect of a single dose of WH138 on urinary sodium excretion in adult males. -An open-label, dose-escalation study- |
| Date of disclosure of the study information | 2023/05/31 |
| Last modified on | 2023/09/07 15:55:00 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The effect of a single dose of WH138 on urinary sodium excretion in adult males. -An open-label, dose-escalation study-
Acronym
Interventional study of WH138 on adult males
Scientific Title
The effect of a single dose of WH138 on urinary sodium excretion in adult males. -An open-label, dose-escalation study-
Scientific Title:Acronym
Interventional study of WH138 on adult males
Region
| Japan |
Condition
Condition
Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of a single dose of WH138 on urinary sodium excretion, safety, and absorption in adult males.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary sodium excretion and urine volume
Urinary WH138 excretion
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Period 1 (No intake)
Period 2 (WH138, Low-dose, single dose administration)
Period 3 (WH138, High-dose, single dose administration)
Interventions/Control_2
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
| 65 | years-old | >= |
Gender
Male
Key inclusion criteria
1) Subjects who are voluntarily giving written informed consent.
2) Adult males aged between 20 and 65
3) Subjects who can take meals, take urine samples and keep a resting state on the schedule indicated by investigators.
Key exclusion criteria
1) Subjects who have possibilities for allergy related to the test food
2) Subjects whose clinical inspection results are estimated inappropriate to this study by principal investigator.
3) Subjects who have or had disorder in digestive, circulatory or endocrine system and who are estimated inappropriate to this study by principal investigator.
4) Subjects who are excess of daily salt intake.
5) Subjects who are estimated inappropriate to participate to this study by principal investigator.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tomomi |
| Middle name | |
| Last name | Ueno |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5, Azahigashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga
TEL
0952-52-1522
Ueno.Tomomi@otsuka.jp
Public contact
Name of contact person
| 1st name | Ayuko |
| Middle name | |
| Last name | Oyama |
Organization
Otsuka Pharmaceutical Co., Ltd
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5, Azahigashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga
TEL
0952-52-1522
Homepage URL
Oyama.Ayuko@otsuka.jp
Sponsor or person
Institute
Otsuka Pharmaceutical Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical Co., Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Otsuka Pharmaceutical Co., Ltd
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo
Tel
090-5393-1433
shimizu_se@otsuka.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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
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
| 2022 | Year | 03 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 03 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053747
