Investigation of correlation between DNA methylation in hepatic derived cells and CYP3A4 actibity in healthy volunteers

Yoshihara Tatsuya0 sites20 target enrollmentOctober 15, 2019

Conditionshealthy male and female

Overview

Phase: 未知
Intervention: Not specified
Conditions: healthy male and female
Sponsor: Yoshihara Tatsuya
Enrollment: 20
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

who.int

Start Date

October 15, 2019

End Date

January 24, 2020

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Yoshihara Tatsuya

Eligibility Criteria

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.

Exclusion Criteria

•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