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.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001289606

Acronym

EPOC-15

Enrollment

Registered

2014-12-10

Start date

2015-07-28

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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

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 ciprofloxicin 250mg oral tablet twice daily for three days on study Days 11 to 13 .

Study design

Allocation

Non-randomised trial

Primary purpose

Diagnosis

Eligibility

Sex/Gender

Male

Age

21 Years to 35 Years

Healthy volunteers

Yes

Inclusion criteria

Healthy Non-smoker BMI in the range 18 to 30

Exclusion criteria

1. Use of prescription, over-the-counter, complimentary or recreational drugs during seven days prior and for the duration of the study. Paracetamol is permitted. 2. Current cigarette smoker. 3. Consumption of grapefruit juice in the period 48 hours prior and for the duration of the study. 4. Prior allergy or adverse reaction to any of the drugs used in the study.

Outcome results