UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007295 |
|---|---|
| Receipt number | R000008603 |
| Scientific Title | Influence of paraoxonase 3 on pharmacokinetics of simvastatin in healthy volunteers |
| Date of disclosure of the study information | 2012/03/01 |
| Last modified on | 2019/03/25 17:56:37 |
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Basic information
Public title
Influence of paraoxonase 3 on pharmacokinetics of simvastatin in healthy volunteers
Acronym
Relationships between simvastatin PK and PON3 activity
Scientific Title
Influence of paraoxonase 3 on pharmacokinetics of simvastatin in healthy volunteers
Scientific Title:Acronym
Relationships between simvastatin PK and PON3 activity
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Medicine in general | Cardiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate relationships between individual difference in paraoxonase 3 activity and inter-individual variability of simvastatin pharmacokinetics
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum paraoxonase-3 activity
Serum paraoxonase-3 concentration
Plasma concentrations of simvastatin
Plasma concentrations of midazolam
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
For in vitro assay, participants are taken a blood sampling under an overnight fasting. As to a clinical trial, on the day 1, subjects are administered single 10 mg of simvastatin orally, and undergo serial blood sampling up to 24 hr. On the day 2, subjects are administered 0.05 mg/kg of midazolam orally, and undergo serial blood sampling up to 24 hr.
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 adults
Key exclusion criteria
Smoker
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yayoi Kameoka |
Organization
Fukushima Medical University
Division name
School of Medicine, Department of Pharmacology
Zip code
Address
1 Hikarigaoka, Fukushima 9601295, Japan
TEL
024-548-2111
misaka@fmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingen Misaka |
Organization
Fukushima Medical University
Division name
School of Medicine, Department of Pharmacology
Zip code
Address
1 Hikarigaoka, Fukushima 9601295, Japan
TEL
+81-24-548-2111
Homepage URL
misaka@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Research Grant from YOKOYAMA Foundation for Clinical Pharmacology, Japan Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 03 | 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
Completed
Date of protocol fixation
| 2012 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2012 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 15 | Day |
Last modified on
| 2019 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008603
