UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003774 |
|---|---|
| Receipt number | R000004506 |
| Scientific Title | The effect of CES1A genetic polymorphism on the pharmacokinetics of Oseltamivir |
| Date of disclosure of the study information | 2010/06/18 |
| Last modified on | 2013/02/19 00:45:15 |
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Basic information
Public title
The effect of CES1A genetic polymorphism on the pharmacokinetics of Oseltamivir
Acronym
CES1A polymorphism and the pharmacokinetics of Oseltamivir
Scientific Title
The effect of CES1A genetic polymorphism on the pharmacokinetics of Oseltamivir
Scientific Title:Acronym
CES1A polymorphism and the pharmacokinetics of Oseltamivir
Region
| Japan |
Condition
Condition
Japanese healthy subjects
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The aims of this study are to clarify the effect of CES1 genetic polymorphism on the pharmacokinetics of prodrug.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
AUC(Ro64-0802)
Key secondary outcomes
AUC (Oseltamivir), Cmax, C 12h, CL/f , Vd/f , tmax, t1/2, MRT (Oseltamivir and Ro64-0802), VAS
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
The subjects will be administered a single-dose 75 mg of Oseltamivir once.
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
1) 20 years of age or older.
2) BMI between 18 and 30 kg/m2.
3) Subjects who are able to understand and follow instructions and who are able to participate in the study for the entire period.
4) Subjects must have given their written informed consent to participate in the study after receiving adequate previous information and prior to any study specific procedures.
Key exclusion criteria
1) The disease to need continuous medical treatment.
2) The liver and renal dysfunction and the psychic disease
3) Screening test results likely to show inappropriateness for participation in this study.
4) Febrile illness within 1 week before the first drug administration.
5) Subjects with a history of severe allergies, non-allergic drug reactions, or multiple drug allergies.
6) Use of any ethical drug medication within 1 week before the first drug administration.
7) Consumption of the grapefruit-containing beverages within 1 week before the first drug administration.
8) Consumption of the St. Jone's Wirt-containing supplement within 1 week before the first drug administration.
9) Consumption of the cigarettes within 1 week before the first drug administration.
10) Pregnancy or lactation in women.
11) Participation in a clinical trial of an investigational drug within 4 months or of an approved drug within 3 months before the first drug administration.
12) Blood donation of 400 mL of whole blood within 3 months or 200 mL of whole blood within 1 month or blood components (plasma and platelet) within 2 weeks before the first drug administration.
13) Any others judged by the investigators to be inappropriate for the subject of this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuki SUZAKI |
Organization
Oita University Hospital
Division name
General Clinical Research Center
Zip code
Address
Hasama-machi, Yufu-shi, Oita
TEL
097-586-5954
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuki SUZAKI |
Organization
Oita University Hospital
Division name
General Clinical Research Center
Zip code
Address
Hasama-machi, Yufu-shi, Oita
TEL
097-586-5954
Homepage URL
ysuzaki@med.oita-u.ac.jp
Sponsor or person
Institute
Oita University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japanese Research Foundation for Clinical Pharmacology
Organization
Division
Category of Funding Organization
Non profit foundation
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
大分大学医学部附属病院（大分大学）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2010 | Year | 05 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 17 | Day |
Last modified on
| 2013 | Year | 02 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004506
