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Trial registered on ANZCTR


Registration number
ACTRN12613000398707
Ethics application status
Approved
Date submitted
9/04/2013
Date registered
11/04/2013
Date last updated
29/07/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
An open label, phase I single application study to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal oxycodone patch.
Scientific title
An open label, single dose, phase I pilot study in healthy volunteers to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal oxycodone patch to promote pain relief.
Secondary ID [1] 282254 0
Nil
Universal Trial Number (UTN)
Trial acronym
POH029-12
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To promote pain relief, tested in healthy volunteers. 288779 0
Condition category
Condition code
Anaesthesiology 289133 289133 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single centre, open-label, single application study in a total of 12 healthy participants.

Eligible participants will receive a single 3 day application of a transdermal patch containing 72 mg of oxycodone in combination with TPM (tocopheryl phosphate mix) with a subsequent 3 day in-house period (this period is used to ensure washout of the oxycodone to a safe level prior to discharge).
Intervention code [1] 286873 0
Treatment: Drugs
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289248 0
To characterise the pharmacokinetic profile of oxycodone delivered transdermally using the oxycodone patch.

Pharmacokinetic profile will be assessed through collection of blood samples at various time points during each 3 day patch application and during the wash out period. A total of 40 blood samples will be collected from each participant and analysed
Timepoint [1] 289248 0
Pharmacokinetic profile will be assessed through collection of blood samples at various time points. On Day 1 there will be an intensive blood sampling period in which samples will be collected every 1-2hrs and for the duration of the in-house period sample will be collected every 4-8hrs. A total of 40 blood samples will be collected from each participant and analysed.
Secondary outcome [1] 302098 0
To evaluate the safety and tolerability of oxycodone delivered transdermally from the oxymorphone patch.

Safety and tolerability will be assessed by:
* The frequency of Adverse Events
* The frequency of skin irritation at site
* Clinically important changes in Vital signs
* Clinically important changes in laboratory tests and assessments
Timepoint [1] 302098 0
Safety and tolerability will be assessed by:
* The frequency of Adverse Events measured throughout study participation
* The frequency of skin irritation at site monitored after patch removal
* Clinically important changes in Vital signs monitored twice daily throughout the in-house period
* Clinically important changes in laboratory tests and assessments monitored at screening, check-in, Day 4, discharge and follow up (5-7 days post discharge)

Eligibility
Key inclusion criteria
Healthy male subjects, aged 18 to 55 years inclusive, body mass index greater than or equal to 19 and less than or equal to 27 kg/m2, weight >50 kg, free from clinically significant illness or disease, as defined.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Evidence of clinically significant impairment/disorders.
* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
* Have a rested systolic blood pressure of < 90 mmHg or > 160 mmHg and/or diastolic blood pressure of < 50 mmHg or > 95 mmHg.
* History of obstructive airway disease or any condition that may increase the risk for respiratory depression.
* A resting pulse rate at rest of < 45 Beats Per Minute (BPM) or > 100 BPM.
* History of neurologic conditions or convulsive disorders, severe head injury or increased intracranial pressure.
* A calculated creatinine clearance of < 85 mL/minute
* Have undergone surgery or received anaesthetic within 30 days of Day 1.
* Use of central nervous system depressants within 30 days of Day 1.
* Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1.
* Use of any prescription medication, over the counter product, herbal product, diet aid, or hormone supplement, within 14 days of Day 1 and for duration of study.
* Known intolerance, allergy or hypersensitivity reactions to naltrexone, naloxone, oxycodone, opioid analgesics, or any commercially available adhesives.
* Any history of a dermatological condition or recurrent generalised skin disorder within the last 5 years.
* Any tattoos, bruises, scars or skin lesions on the area where the patch is to be applied.
* Consumption of grapefruit, grapefruit juice or any products containing CYP3A4 inhibitors and inducers within 14 days of Day 1 and through to discharge.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be sequentially assigned to the treatment group. Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequentially assigned to the treatment group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics
Statistical methods / analysis
The sample size was not chosen using any formal power calculations as there are no formal hypotheses to be tested in this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
22/04/2013
Actual
22/04/2013
Date of last participant enrolment
Anticipated
7/04/2014
Actual
30/04/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6657 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 287018 0
Commercial sector/Industry
Name [1] 287018 0
Phosphagenics Ltd
Country [1] 287018 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 285801 0
None
Name [1] 285801 0
Address [1] 285801 0
Country [1] 285801 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289058 0
Bellberry Limited
Ethics committee address [1] 289058 0
Ethics committee country [1] 289058 0
Australia
Date submitted for ethics approval [1] 289058 0
Approval date [1] 289058 0
04/04/2013
Ethics approval number [1] 289058 0

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

Contacts
Principal investigator
Name 39022 0
Dr Sepehr Shakib
Address 39022 0
CMAX
Level 5 East Wing Royal Adelaide Hospital
North Terrace
Adelaide SA 5000
Australia
Country 39022 0
Australia
Phone 39022 0
+61 8 8222 3923
Fax 39022 0
Email 39022 0
alison.monkhouse@cmax.com.au
Contact person for public queries
Name 39023 0
Alisha Smith
Address 39023 0
11 Duerdin Street, Clayton VIC 3168
Country 39023 0
Australia
Phone 39023 0
+61 3 9565 1119
Fax 39023 0
Email 39023 0
asmith@phosphagenics.com
Contact person for scientific queries
Name 39024 0
Alisha Smith
Address 39024 0
11 Duerdin Street, Clayton VIC 3168
Country 39024 0
Australia
Phone 39024 0
+61 3 9565 1119
Fax 39024 0
Email 39024 0
asmith@phosphagenics.com

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.