UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010796 |
|---|---|
| Receipt number | R000012637 |
| Scientific Title | Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers |
| Date of disclosure of the study information | 2013/05/24 |
| Last modified on | 2013/05/24 10:40:39 |
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Basic information
Public title
Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers
Acronym
Impact of CYP2A6 and CHRM3 polymorphisms on the PK/PD of pilocarpine
Scientific Title
Impact of CYP2A6 and CHRM3 genetic polymorphisms on the PK/PD of pilocarpine in Japanese healthy volunteers
Scientific Title:Acronym
Impact of CYP2A6 and CHRM3 polymorphisms on the PK/PD of pilocarpine
Region
| Japan |
Condition
Condition
Sjogren's syndrome
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
This study evaluates the effects of polymorphisms in CYP2A6*4 and CHRM3 on sialagogic drug pilocarpine. The blood concentrations of pilocarpine and the amount of saliva will be associated with these polymorphisms.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The amount of saliva after pilocarpine administration
Key secondary outcomes
The blood concentration of pilocarpine
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
single oral administration of pilocarpine.
salagen (KISSEI PHARMACEUTICAL CO.,LTD.)
5mg 1Tablet.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Healthy Japanese adult volunteers.
BMI lower limit is 17kg/m2
BMI upper limit is 28kg/m2
Key exclusion criteria
Hepatic dysfunction
(AST <50IU/L, ALT >50IU/L)
Renal dysfunction
(eGFR <80mL/min/1.73m2)
Smoker
Pregnant woman
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Hamasaki |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
097-586-5952
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Hamasaki |
Organization
Oita University Faculty of Medicine
Division name
Department of Clinical Pharmacology & Therapeutics
Zip code
Address
1-1 Hasama-machi, Yufu city, Oita, 879-5593, Japan
TEL
097-586-5952
Homepage URL
rinyaku@oita-u.ac.jp
Sponsor or person
Institute
Oita University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Oita University Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大分大学医学部臨床薬理学講座
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 03 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 24 | Day |
Last modified on
| 2013 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012637
| 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 |
