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Trial registered on ANZCTR
Registration number
ACTRN12614001289606
Ethics application status
Approved
Date submitted
28/11/2014
Date registered
10/12/2014
Date last updated
7/07/2017
Type of registration
Prospectively registered
Titles & IDs
Public title
Using the chemicals in the human body to predict the optimal dose of orally administered anticancer drugs.
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Scientific title
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.
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Secondary ID [1]
285752
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None
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Universal Trial Number (UTN)
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Trial acronym
EPOC-15
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Pharmacology
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Oncology
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Condition category
Condition code
Other
293934
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0
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Research that is not of generic health relevance and not applicable to specific health categories listed above
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
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 .
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Intervention code [1]
290713
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Early detection / Screening
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Comparator / control treatment
Not Applicable
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Midazolam concentrations-time profile. Plasma-midazolam concentrations will be determined by LC-MS.
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Assessment method [1]
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Timepoint [1]
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Sampling to occur at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4 and 6 hours post administration of midazolam on each study day (days 0, 7 and 14).
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Primary outcome [2]
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Plasma concentrations of endogenous compounds. Plasma concentrations of endogenous compounds will be determined by LC-MS.
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Assessment method [2]
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Timepoint [2]
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Sampling to occur prior to midazolam administration on each study day (days 0, 7 and 14).
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Secondary outcome [1]
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None
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Assessment method [1]
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Timepoint [1]
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None
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Eligibility
Key inclusion criteria
Healthy
Non-smoker
BMI in the range 18 to 30
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Minimum age
21
Years
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Maximum age
35
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
28/07/2015
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
78
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
9000
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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Flinders University
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Address [1]
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Flinders Drive
Bedford Park
South Australia 5042
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Flinders University
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Address
Flinders Drive
Bedford Park
South Australia 5042
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
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Flinders Medical Center
Flinders Drive
Bedford Park
South Australia 5042
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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15/12/2014
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Approval date [1]
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03/03/2015
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Ethics approval number [1]
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11.15 - HREC/15/SAC/5
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Summary
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
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Andrew Rowland
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Address
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Department of Clinical Pharmacology Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
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Country
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Australia
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Phone
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+61 8 8204 7546
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ms Madele van Dyk
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Address
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Department of Clinical Pharmacology Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
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Country
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Australia
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Phone
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+61 8 8204 3155
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Andrew Rowland
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Address
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Department of Clinical Pharmacology Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
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Country
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Australia
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Phone
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+61 8 8204 7546
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
Source
Title
Year of Publication
DOI
Embase
Identification of the caffeine to trimethyluric acid ratio as a dietary biomarker to characterise variability in cytochrome P450 3A activity.
2019
https://dx.doi.org/10.1007/s00228-019-02682-5
Embase
Validation of a 3-H sampling interval to assess variability in cytochrome P450 3A phenotype and the impact of induction and mechanism-based inhibition using midazolam as a probe substrate.
2019
https://dx.doi.org/10.3389/fphar.2019.01120
N.B. These documents automatically identified may not have been verified by the study sponsor.
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