UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of correlation between pharmacokinetics of midazolam and DNA methylation in hepatic derived cells to predict CYP3A4 activity
Title of the study (Brief title)	Investigation of correlation between pharmacokinetics of midazolam and DNA methylation
Region	Japan

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

Objectives
Narrative objectives1	1) to evaluate DNA methylation levels as biomarker for CYP3A4 activity 2) to evaluate the distribution of DNA methylation levels in hepatic derived cells 3) to explore the biomarker for CYP3A4 activity using metabolome analysis
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	pharmacokinetics of midazolam, DNA methylation levels in hepatic derived cells, and disposition of endogenous compounds
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	midazolam (oral), wash out, midazolam (iv)
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) taking drugs or healthy foods which may affect drug metabolism.
Target sample size	20

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

Public contact
Name of contact person	Miyuki Kimura
Organization	LTA
Division name	Fukuoka Mirai Hospital
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	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 06 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 06 Month 09 Day
Last modified on	2018 Year 03 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020675