RecruitingACTRN12614001289606

Using the chemicals in the human body to predict the optimal dose of orally administered anticancer drugs.

An investigation of the proportional change in plasma concentration of endogenous compounds relative to a pathway probe for CYP3A4 (midazolam) when administered with and without enzyme inducers and inhibitors, in healthy adult volunteers.


Sponsor

Flinders University

Enrollment

78 participants

Start Date

Jul 28, 2015

Study Type

Interventional

Conditions

Summary

Identify an endogenous metabolic phenotype for the enzyme CYP3A4 that can be used as a component of a pathway phenotyping panel to optimise anticancer drug dosing


Eligibility

Sex: MalesMin Age: 21 YearssMax Age: 35 Yearss

Plain Language Summary

Simplified for easier understanding

This study is looking for natural body chemicals (called endogenous metabolites) that can predict how quickly a healthy person breaks down certain anti-cancer drugs. An enzyme called CYP3A4 processes many medications in the liver, but people vary widely in how active this enzyme is. Identifying a reliable body marker for CYP3A4 activity could help doctors personalise cancer drug doses so each patient gets the right amount — not too much and not too little. You may be eligible if: - You are male - You are between 21 and 35 years old - You are in good health - You are a non-smoker - Your BMI is between 18 and 30 You may NOT be eligible if: - You smoke cigarettes - You have taken any prescription, over-the-counter, herbal, or recreational drugs in the last 7 days - You have drunk grapefruit juice in the last 48 hours - You have had a previous allergic reaction to any study drug Talk to your doctor about whether this trial might be right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Administration of a single dose of midazolam (1mg; oral tablet) on three occasions on study days 0,7 and 14. Administration of rifampicin 300mg oral tablet once daily for 7 days on study days 1 to 7.

Administration of a single dose of midazolam (1mg; oral tablet) on three occasions on study days 0,7 and 14. Administration of rifampicin 300mg oral tablet once daily for 7 days on study days 1 to 7. Administration of ciprofloxicin 250mg oral tablet twice daily for three days on study Days 11 to 13 .


Locations(1)

Flinders Medical Centre - Bedford Park

SA, Australia

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ACTRN12614001289606


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