UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017842 |
|---|---|
| Receipt number | R000020675 |
| Scientific Title | Investigation of correlation between pharmacokinetics of midazolam and DNA methylation in hepatic derived cells to predict CYP3A4 activity |
| Date of disclosure of the study information | 2015/06/12 |
| Last modified on | 2018/03/14 13:53:39 |
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Basic information
Public title
Investigation of correlation between pharmacokinetics of midazolam and DNA methylation in hepatic derived cells to predict CYP3A4 activity
Acronym
Investigation of correlation between pharmacokinetics of midazolam and DNA methylation
Scientific Title
Investigation of correlation between pharmacokinetics of midazolam and DNA methylation in hepatic derived cells to predict CYP3A4 activity
Scientific Title:Acronym
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
| 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
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
miyuki-kimura@lta-med.com
Sponsor or person
Institute
Clinical Pharmacokinetics, Graduate School of Pharmaceutical Sciences, Kyushu University
Institute
Department
Personal name
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)
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 12 | 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
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020675
