UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049052 |
|---|---|
| Receipt number | R000055884 |
| Scientific Title | Exploratory study of a new phenotyping method for the evaluation of CYP1A2 activity |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2023/03/30 09:21:02 |
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Basic information
Public title
Development of a method to evaluate the function of metabolizing enzyme CYP1A2
Acronym
Development of evaluation method for metabolizing enzyme CYP1A2
Scientific Title
Exploratory study of a new phenotyping method for the evaluation of CYP1A2 activity
Scientific Title:Acronym
Exploratory study to evaluate CYP1A2 activity
Region
| Japan |
Condition
Condition
healthy subject
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we validate a new phenotyping method using the metabolism of melatonin to 6-hydroxymelatonin by CYP1A2.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Melatonin pharmacokinetic parameters (melatonin 6-hydroxy metabolic clearance, plasma 6-hydroxy melatonin/melatonin ratio)
Key secondary outcomes
Caffeine pharmacokinetic parameters (caffeine clearance, plasma caffeine/paraxanthine ratio)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Food |
Interventions/Control_1
Caffeine intake from food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Persons who have given consent for this study
Key exclusion criteria
1) Persons who do not consume caffeine-containing products (coffee, tea, soft drinks) on a daily basis (2 to 3 times a week).
2) Persons who have experienced adverse reactions (palpitations, nausea, etc.) to caffeine-containing products (coffee, tea, soft drinks). Persons who are allergic to caffeine
3) Persons who have ever felt sick from blood sampling.
4) Persons who are under medical treatment, pregnant women or those who are thought to be pregnant or nursing
5) Persons who have subjective symptoms of hyperacidity on interview, persons who have been diagnosed with heart disease or gastric ulcer
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Akitomo |
| Middle name | |
| Last name | Yokokawa |
Organization
School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
Division name
Laboratory of Clinical Chemistry and Experimental Therapeutics
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo
TEL
042-676-5803
yokokawa@toyaku.ac.jp
Public contact
Name of contact person
| 1st name | Akitomo |
| Middle name | |
| Last name | Yokokawa |
Organization
School of Pharmacy, Tokyo University of Pharmacy and Life Sciences
Division name
Laboratory of Clinical Chemistry and Experimental Therapeutics
Zip code
192-0392
Address
1432-1 Horinouchi, Hachioji, Tokyo
TEL
042-676-5803
Homepage URL
yokokawa@toyaku.ac.jp
Sponsor or person
Institute
Tokyo University of Pharmacy and Life Sciences
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Human Subjects Review Board of the Tokyo University of Pharmacy and Life Sciences
Address
1432-1 Horinouchi, Hachioji, Tokyo
Tel
042-676-5111
rinri-office-ml@toyaku.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
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2022 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 08 | 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 | 09 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000055884
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
