Trial Review

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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.
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.
Secondary ID [1] 285752 0
None
Universal Trial Number (UTN)
Trial acronym
EPOC-15
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pharmacology
 293638 0
Oncology 293688 0
Condition category
Condition code
Other 293934 293934 0 0
Research that is not of generic health relevance and not applicable to specific health categories listed above

Intervention/exposure
Study type
Interventional
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 .
Intervention code [1] 290713 0
Early detection / Screening
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293707 0
Midazolam concentrations-time profile. Plasma-midazolam concentrations will be determined by LC-MS.
Timepoint [1] 293707 0
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).
Primary outcome [2] 293708 0
Plasma concentrations of endogenous compounds. Plasma concentrations of endogenous compounds will be determined by LC-MS.
Timepoint [2] 293708 0
Sampling to occur prior to midazolam administration on each study day (days 0, 7 and 14).
Secondary outcome [1] 311644 0
None
Timepoint [1] 311644 0
None

Eligibility
Key inclusion criteria
Healthy
Non-smoker
BMI in the range 18 to 30
Minimum age
21 Years
Maximum age
35 Years
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
78
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3222 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 9000 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 290321 0
University
Name [1] 290321 0
Flinders University
Country [1] 290321 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 289038 0
None
Name [1] 289038 0
Address [1] 289038 0
Country [1] 289038 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292031 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 292031 0
Flinders Medical Center
Flinders Drive
Bedford Park
South Australia 5042
Ethics committee country [1] 292031 0
Australia
Date submitted for ethics approval [1] 292031 0
15/12/2014
Approval date [1] 292031 0
03/03/2015
Ethics approval number [1] 292031 0
11.15 - HREC/15/SAC/5

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
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 53126 0
Dr Andrew Rowland
Address 53126 0
Department of Clinical Pharmacology Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Country 53126 0
Australia
Phone 53126 0
+61 8 8204 7546
Fax 53126 0
Email 53126 0
andrew.rowland@flinders.edu.au
Contact person for public queries
Name 53127 0
Ms Madele van Dyk
Address 53127 0
Department of Clinical Pharmacology Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Country 53127 0
Australia
Phone 53127 0
+61 8 8204 3155
Fax 53127 0
Email 53127 0
vand0307@flinders.edu.au
Contact person for scientific queries
Name 53128 0
Dr Andrew Rowland
Address 53128 0
Department of Clinical Pharmacology Flinders Medical Centre Flinders Drive Bedford Park South Australia 5042
Country 53128 0
Australia
Phone 53128 0
+61 8 8204 7546
Fax 53128 0
Email 53128 0
andrew.rowland@flinders.edu.au

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
SourceTitleYear of PublicationDOI
EmbaseIdentification of the caffeine to trimethyluric acid ratio as a dietary biomarker to characterise variability in cytochrome P450 3A activity.2019https://dx.doi.org/10.1007/s00228-019-02682-5
EmbaseValidation 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.2019https://dx.doi.org/10.3389/fphar.2019.01120
N.B. These documents automatically identified may not have been verified by the study sponsor.