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Trial registered on ANZCTR


Registration number
ACTRN12611000811909
Ethics application status
Approved
Date submitted
2/08/2011
Date registered
2/08/2011
Date last updated
2/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the drug interaction potential of extended-release felodipine 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) and one Pgp probe (digoxin) when administered with and without steady-state oral felodipine, in twelve healthy adult volunteers.
Secondary ID [1] 262760 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Drug-drug interactions 270471 0
Condition category
Condition code
Other 270625 270625 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 six drugs (caffeine 100mg, losartan 25mg, omperazole 20mg, dextromethorphan 30mg, midazolam 2mg, digoxin 250mcg) on two occasions a week apart. These drugs will be administered orally (as tablets - caffeine, losartan, omeprazole, digoxin; as solutions diluted in water - midazolam, dextromethorphan) with water. Administration of felodipine extended-release 10mg daily, commencing the day after the first administration of the six drug panel and continuing until the time of second administration of the panel. The felodipine will be given as tablets with water.
Intervention code [1] 267103 0
Other interventions
Intervention code [2] 267105 0
Treatment: Drugs
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269352 0
Probe drug concentrations at various times after administration. Blood will be sampled at the following times - 0h, 0.25h, 05h, 1h, 1.5h, 2h, 2.5h, 3h, 4h, 6h, 8h, 10h and 24h. Plasma drug concentrations will be determined using LC-MS. Clinical assessment and monitoring of heart rate and blood pressure will be used to monitor safety on the days when the six drug combination is given.
Timepoint [1] 269352 0
Sampling to occur for 24 hours after panel of probe drugs is administered.
Secondary outcome [1] 279439 0
nil
Timepoint [1] 279439 0
nil

Eligibility
Key inclusion criteria
Healthy
Aged 18-50
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
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)
recruited through advertising
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
n/a
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
All participants receive the same drugs at the same point in time according to the protocol. There are two phases to the study which occur sequentially. The AUC for each probe drug is determined without felodipine (in phase 1) and then with felodipine (in phase 2). The phase 1 and phase 2 AUCs are compared for each subject and also as a group. This is standard for this type of drug interaction study.
Phase
Not Applicable
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 269581 0
University
Name [1] 269581 0
Flinders University
Country [1] 269581 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 266615 0
None
Name [1] 266615 0
Address [1] 266615 0
Country [1] 266615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269533 0
Flinders Medical Centre Clinical Research Ethics Committee
Ethics committee address [1] 269533 0
Ethics committee country [1] 269533 0
Australia
Date submitted for ethics approval [1] 269533 0
Approval date [1] 269533 0
28/07/2011
Ethics approval number [1] 269533 0
1/11/0307

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32965 0
Address 32965 0
Country 32965 0
Phone 32965 0
Fax 32965 0
Email 32965 0
Contact person for public queries
Name 16212 0
Ben Snyder
Address 16212 0
Department of Clinical Pharmacology
Flinders Medical Centre
Bedford Park
South Australia 5042
Country 16212 0
Australia
Phone 16212 0
+61 8 8204 5202
Fax 16212 0
Email 16212 0
[email protected]
Contact person for scientific queries
Name 7140 0
Ben Snyder
Address 7140 0
Department of Clinical Pharmacology
Flinders Medical Centre
Bedford Park
South Australia 5042
Country 7140 0
Australia
Phone 7140 0
+61 8 8204 5202
Fax 7140 0
Email 7140 0
[email protected]

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.