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

JRCT ID: jRCTs071190031

Registered date:15/10/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: healthy male and female
• Date of first enrollment: 15/10/2019
• Target sample size: 20
• Study type: Interventional

Intervention(s)

1) midazolam (oral)
2) midazolam (iv)

Outcome(s)

• Primary Outcome: Correlation between DNA methylation in hepatic derived cells and midazolam pharmacokinetics

Secondary Outcome

Correlation between miRNA and protein in hepatic derived cells and midazolam pharmacokinetics
Correlation between miRNA and protein in hepatic derived exosomes and midazolam pharmacokinetics
Correlation between miRNA in urine derived exosomes and midazolam pharmacokinetics

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 45age old
• Gender: Both

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Yoshihara Tatsuya
• Secondary Sponsor: Ieiri Ichiro