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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023917
Receipt No. R000027543
Scientific Title Evaluation of the effects of OATP1B1*15 on the plasma concentrations of endogenous compounds (metabolome analysis)
Date of disclosure of the study information 2016/09/03
Last modified on 2018/03/05

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Basic information
Public title Evaluation of the effects of OATP1B1*15 on the plasma concentrations of endogenous compounds (metabolome analysis)
Acronym Exploration for the biomarkers for OATP1B1*15
Scientific Title Evaluation of the effects of OATP1B1*15 on the plasma concentrations of endogenous compounds (metabolome analysis)
Scientific Title:Acronym Exploration for the biomarkers for OATP1B1*15
Region
Japan

Condition
Condition healthy male and female
Classification by specialty
Adult
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 1) to explore the biomarkers for OATP1B1*15
2) to investigate the circadian rhythm of endogenous compounds
3) to evaluate the effects of OATP1B1*15 on the pharmacokinetics of substrates
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes the plasma concentrations of endogenous compounds
pharmacokinetics of atorvastatin, pitavastatin, rosuvastatin, and fluvastatin
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 Treatment
Type of intervention
Medicine
Interventions/Control_1 substrate cocktail
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
45 years-old >=
Gender Male and Female
Key inclusion criteria The investigators must ensure that all subjects being considered meet the following
inclusion criteria:
1) Japanese healthy male or female who is capable to understand and sign the informed consent
2) 20-45 years of age
3) BMI 17.6-26.4
4) good health as determined by physical examination, vital signs and laboratory tests.
Key exclusion criteria The investigators must ensure that all subjects being considered meet the following
exclusion criteria or conditions:
1) history of allergy to any drugs
2) medical attention within 2 months prior to participation
3) donation of 200 mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation
4) donation of 400 mL or more of blood within 12 weeks prior to participation
5) recent (past 4 months) participation in other clinical trial for investigational new chemical entity
6) history of drug abuse
7) alcohol abuse.
8) lactose intolerance
9) taking drugs or healthy foods which may affect drug metabolism
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shunji Matsuki
Organization LTA
Division name Fukuoka Mirai Hospital
Zip code
Address 3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
TEL 092-662-3608
Email shunji-matsuki@lta-med.com

Public contact
Name of contact person
1st name
Middle name
Last name Miyuki Kimura
Organization LTA
Division name Fukuoka Mirai Hospital
Zip code
Address 3-5-1, Kashiiteruha, Higashi-ku, Fukuoka
TEL 092-662-3608
Homepage URL
Email miyuki-kimura@lta-med.com

Sponsor
Institute Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University
Institute
Department

Funding Source
Organization Japanese Society for the Promotion of Science
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 03 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
2016 Year 07 Month 12 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 09 Month 02 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027543

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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