UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052385 |
|---|---|
| Receipt number | R000059612 |
| Scientific Title | Pharmacokinetic study of lysophosphatidylcholine in healthy volunteers: A randomized controlled trial |
| Date of disclosure of the study information | 2023/10/03 |
| Last modified on | 2023/10/03 11:23:40 |
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Basic information
Public title
Pharmacokinetic study of lysolecithin in healthy volunteers
Acronym
Pharmacokinetic study of lysolecithin
Scientific Title
Pharmacokinetic study of lysophosphatidylcholine in healthy volunteers: A randomized controlled trial
Scientific Title:Acronym
Pharmacokinetic study of lysophosphatidylcholine in a randomized controlled trial
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate the pharmacokinetics of lysophosphatidylcholine.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
･Changes in plasma choline concentration, and the delta Cmax and incremental area under the curve (iAUC)
･Changes in plasma lysophosphatidylcholine concentration, and the delta Cmax and iAUC
Key secondary outcomes
･Changes in serum phospholipids concentration, and the delta Cmax and iAUC
･Changes in serum triglyceride concentration, and the delta Cmax and iAUC
･Changes in plasma trimethylamine N-oxide concentration, and the delta Cmax and iAUC
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
1. The intake of lysolecithin
Interventions/Control_2
2. The intake of placebo (same lipid amount as 1)
Interventions/Control_3
3. The intake of glycerophosphocholine (same choline amount as 1)
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
Key inclusion criteria
1. Provided written informed consent to participate in the study.
2. Male older than 20 years (inclusive) at the time of the consent.
3. Has no health conditions that would prevent him from fulfilling the study requirements, as judged by the principal investigator based on the screening laboratory test.
4. Able to join and finish the study in a designated schedule.
Key exclusion criteria
1. Has any serious impairment in the liver, kidney, and the circulatory organ.
2. Has a blood pressure and/or pulse rate that extremely deviates from the normal range.
3. Has or had a digestive disorder affects the absorption of the supplement.
4. Regularly takes an oral medicine.
5. Took oral medicines and/or supplements within 1 week of the study commencement, which the principal investigator believes confounds the interpretation of the study results.
6. Participated in blood donation and/or another clinical trial within 1 month of the study commencement.
7. Is allergic to soy.
8. Has another condition and is judged by the principal investigator to be inappropriate for the study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Koichiro |
| Middle name | |
| Last name | Hamada |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, Japan
TEL
+81-952-52-1522
hamadako@otsuka.jp
Public contact
Name of contact person
| 1st name | Ryohei |
| Middle name | |
| Last name | Tanaka-Kanegae |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Saga Nutraceuticals Research Institute
Zip code
842-0195
Address
5006-5 Aza Higashiyama, Omagari, Yoshinogari-cho, Kanzaki-gun, Saga, Japan
TEL
+81-952-52-1522
Homepage URL
tanaka.ryohei@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
The Research Ethics Committee of Otsuka Pharmaceutical Co., Ltd.
Address
Shinagawa Grand Central Tower, 2-16-4 Konan, Minato-ku, Tokyo 108-8242, Japan
Tel
+81-3-6717-1400
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
大塚製薬株式会社 佐賀栄養製品研究所
Saga Nutraceuticals Research Institute, Otsuka Pharmaceutical Co., Ltd.
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 10 | Month | 03 | 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
12
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
The analysis has not been completed.
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
| 2018 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 07 | Day |
Last follow-up date
| 2018 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 10 | Month | 03 | Day |
Last modified on
| 2023 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059612
