UMIN-CTR Clinical Trial

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
Email

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
Email	ysuzaki@med.oita-u.ac.jp

Sponsor
Institute	Oita University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004506

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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