UMIN-CTR Clinical Trial

Basic information
Public title	Clinical research of celiprolol, fexofenadine, atenolol cocktail-microdose to validate the utility of microdose study on the drug transporter SNP's
Acronym	celiprolol cocktail-microdose
Scientific Title	Clinical research of celiprolol, fexofenadine, atenolol cocktail-microdose to validate the utility of microdose study on the drug transporter SNP's
Scientific Title:Acronym	celiprolol cocktail-microdose
Region	Japan

Condition
Condition	healthy male
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	To evaluate PK profiles of cocktail-dose of celiprolol, fexofenadine and atenolol, and to assess inhibitory effect of grapefruit juice on celiprolol PK, then to identify the relationship between PK profiles and regarded genes.
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	PK profiles of celiprolol, fexofenadine and atenolol
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 Food
Interventions/Control_1	celiprolol, fexofenadine, atenolo and grapefruit juice
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
Key inclusion criteria	the investigors must ensure that all subjects being considerd meet the following inclusion criteria: 1) Japanese healthy male who is capable to understand and sign the informed consent. 2) 20-45 years of age 3)BMI 18.5-25.0 4)good health as determined by physical examination, vital signs and laboartory tests.
Key exclusion criteria	the investigors must ensure that all subjects being considerd 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 200mL or more of blood within 4 weeks prior to participation, or donation of component blood within 2 weeks prior to participation 4)donation of 400mL 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
Target sample size	42

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shin Irie
Organization	LTA
Division name	Kyusyu Clinical Pharmacology Clinic
Zip code
Address	2-13-16 Chigyo Fukuoka
TEL
Email

Public contact
Name of contact person	1st name Middle name Last name Miyuki Kimura
Organization	LTA
Division name	Kyusyu Clinical Pharmacology Clinic
Zip code
Address
TEL	092-733-1001
Homepage URL
Email

Sponsor
Institute	APDD
Institute
Department

Funding Source
Organization	APDD
Organization
Division
Category of Funding Organization
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	2010 Year 10 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	2009 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date	2009 Year 11 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 11 Month 05 Day
Last modified on	2010 Year 10 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003308

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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