Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000451606
Ethics application status
Approved
Date submitted
22/04/2014
Date registered
1/05/2014
Date last updated
3/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the drug interaction potential of modafinil in healthy volunteers, using a cocktail approach
Scientific title
An investigation of the proportional change in area under the concentration-time curves for five orally administered CYP P450 probes (caffeine, losartan, omeprazole, dextromethorphan, midazolam) when administered with and without single-dose and steady-state oral modafinil, in twelve healthy adult volunteers.
Secondary ID [1] 284472 0
MODDI-14
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-drug interactions 291711 0
Condition category
Condition code
Other 292089 292089 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
Simultaenous administration of single doses of five drugs (caffeine 100mg, losartan 25mg, omperazole 20mg, dextromethorphan 30mg, midazolam 2mg) on three occasions on study days 0,1 and 7. These drugs will be administered orally (as tablets - caffeine, losartan, omeprazole; as solutions diluted in water - midazolam, dextromethorphan) with water. Administration of modafinil 200mg daily for seven days on study Days 1 to 7. The modafinil will be given as tablets with water. A single modafinil plasma concentration will be measured post-dose on Day 7 to monitor adherence and to ensure steady-state has been achieved.
Intervention code [1] 289234 0
Treatment: Drugs
Comparator / control treatment
Not Applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291962 0
Probe drug concentrations-time profile following administration of the drug cocktail. Plasma drug concentrations of probe drugs will be determined by LC-MS.
Timepoint [1] 291962 0
Sampling to occur at 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10 and 24 hours post administration of the cocktail of probe drugs.
Primary outcome [2] 292000 0
Clinical assessment and monitoring of heart rate and blood pressure will be used to monitor safety on the days when the five drug combination is given.
Timepoint [2] 292000 0
Monitoring of adverse effects will be undertaken across the full duration of the study (8 days)
Secondary outcome [1] 307931 0
nil
Timepoint [1] 307931 0
nil

Eligibility
Key inclusion criteria
Healthy
Aged 18 - 40
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
taking medications
significant health conditions
unable to comply with study requirements

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
28/11/2014
Actual
Date of last participant enrolment
Anticipated
31/07/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 2355 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 8018 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 289123 0
University
Name [1] 289123 0
Flinders University
Country [1] 289123 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Flinders Drive
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 287784 0
None
Name [1] 287784 0
Address [1] 287784 0
Country [1] 287784 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290903 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 290903 0
Flinders Medical Center
Flinders Drive
Bedford Park
South Australia 5042
Ethics committee country [1] 290903 0
Australia
Date submitted for ethics approval [1] 290903 0
30/05/2014
Approval date [1] 290903 0
16/07/2014
Ethics approval number [1] 290903 0
HREC/14/SAC/203

Summary
Brief summary
To assess the capacity of a vigilance promoting agent (modafinil) to ‘perpetrate’ metabolic drug interactions that may lead to adverse effects.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47886 0
Dr Andrew Rowland
Address 47886 0
Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 47886 0
Australia
Phone 47886 0
+61 8 8204 7546
Fax 47886 0
Email 47886 0
andrew.rowland@flinders.edu.au
Contact person for public queries
Name 47887 0
Andrew Rowland
Address 47887 0
Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 47887 0
Australia
Phone 47887 0
+61 8 8204 7546
Fax 47887 0
Email 47887 0
andrew.rowland@flinders.edu.au
Contact person for scientific queries
Name 47888 0
Andrew Rowland
Address 47888 0
Department of Clinical Pharmacology
Flinders Medical Centre
Flinders Drive
Bedford Park
South Australia 5042
Country 47888 0
Australia
Phone 47888 0
+61 8 8204 7546
Fax 47888 0
Email 47888 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
No additional documents have been identified.