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Trial registered on ANZCTR


Registration number
ACTRN12613000932763
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
23/08/2013
Date last updated
22/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
An open label, phase I study to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from multiple applications of a transdermal oxymorphone patch.
Scientific title
An open label, multiple dose, phase I study in healthy volunteers to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patch to promote pain relief.
Secondary ID [1] 283029 0
Nil
Universal Trial Number (UTN)
Trial acronym
POH032-13
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To promote pain relief, tested in healthy volunteers. 289861 0
Condition category
Condition code
Anaesthesiology 290222 290222 0 0
Pain management

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

Eligible participants will receive 4 x 3 day sequential applications of transdermal patches containing 56.8 mg of oxymorphone per application in combination with TPM (tocopheryl phosphate mix) during a 12 day in-house stay. A subsequent 4 day in-house stay will follow to ensure washout of the oxymorphone to a safe level prior to discharge.During the entire study period, participants will receive naltrexone 50mg orally twice a day to block the systemic effects of oxymorphone.
Intervention code [1] 287751 0
Treatment: Drugs
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290245 0
To characterise the pharmacokinetic profile of oxymorphone delivered transdermally using the oxymorphone patch.
Timepoint [1] 290245 0
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 59 blood samples will be collected from each participant and analysed
Timepoint: 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 59 blood samples will be collected from each participant and analysed.
Secondary outcome [1] 304193 0
To evaluate the safety and tolerability of oxymorphone delivered transdermally from the oxymorphone patch.
Timepoint [1] 304193 0
Safety and tolerability will be assessed by:
* The frequency of Adverse Events. Known/ possible adverse events that have associated with the oxymorphone patch include application site reaction, nausea and dizziness.
* The frequency of skin irritation at site of application
* Clinically important changes in Vital signs
* Clinically important changes in laboratory tests and assessments
Timepoint: 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, Day 10, 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
Gender
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 any ingredients in the patch , naltrexone or naloxone.
* 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 287793 0
Commercial sector/Industry
Name [1] 287793 0
Phosphagenics Limited
Address [1] 287793 0
11 Duerdin St Clayton, Victoria, 3168
Country [1] 287793 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 286523 0
None
Name [1] 286523 0
Address [1] 286523 0
Country [1] 286523 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289743 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 289743 0
229 Greenhill Road Dulwich South Australia 5065
Ethics committee country [1] 289743 0
Australia
Date submitted for ethics approval [1] 289743 0
Approval date [1] 289743 0
12/08/2013
Ethics approval number [1] 289743 0

Summary
Brief summary
The purpose of this study is to understand how well oxymorphone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of a patch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42198 0
Dr Janakan Krishnarajah
Address 42198 0
Linear Clinical Research
1st Floor, B Block, Hospital Avenue, Nedlands WA 6009
Country 42198 0
Australia
Phone 42198 0
+61 8 6382 5124
Fax 42198 0
Email 42198 0
JKrishnarajah@linear.org.au
Contact person for public queries
Name 42199 0
Ms Alisha Smith
Address 42199 0
Phosphagenics Ltd , 11 Duerdin Street, Clayton VIC 3168
Country 42199 0
Australia
Phone 42199 0
+61 3 9565 1119
Fax 42199 0
Email 42199 0
asmith@phosphagenics.com
Contact person for scientific queries
Name 42200 0
Ms Alisha Smith
Address 42200 0
Phosphagenics Ltd, 11 Duerdin Street, Clayton VIC 3168
Country 42200 0
Australia
Phone 42200 0
+61 3 9565 1119
Fax 42200 0
Email 42200 0
asmith@phosphagenics.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary