Investigation of correlation between DNA methylation in hepatic derived cells and CYP3A4 actibity in healthy volunteers
- Conditions
- healthy male and female
- Registration Number
- JPRN-jRCTs071190031
- Lead Sponsor
- Yoshihara Tatsuya
- Brief Summary
Midazolam was administered to a subject whose DNA methylation frequency was determined using hepatocytes obtained from human peripheral blood. The results of this study indicate that the frequency of DNA methylation may be an indicator of CYP3A4 metabolic activity.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 20
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Correlation between DNA methylation in hepatic derived cells and midazolam pharmacokinetics
- Secondary Outcome Measures
Name Time Method Correlation between miRNA and protein in hepatic derived cells and midazolam pharmacokinetics<br>Correlation between miRNA and protein in hepatic derived exosomes and midazolam pharmacokinetics<br>Correlation between miRNA in urine derived exosomes and midazolam pharmacokinetics