An open label, phase I single application study to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal oxycodone patch.
- Conditions
- To promote pain relief, tested in healthy volunteers.Anaesthesiology - Pain management
- Registration Number
- ACTRN12613000398707
- Lead Sponsor
- Phosphagenics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 12
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.
* 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
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To characterise the pharmacokinetic profile of oxycodone delivered transdermally using the oxycodone patch.<br><br>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[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 Measures
Name Time Method To evaluate the safety and tolerability of oxycodone delivered transdermally from the oxymorphone patch.<br><br>Safety and tolerability will be assessed by:<br>* The frequency of Adverse Events <br>* The frequency of skin irritation at site <br>* Clinically important changes in Vital signs<br>* Clinically important changes in laboratory tests and assessments [Safety and tolerability will be assessed by:<br>* The frequency of Adverse Events measured throughout study participation<br>* The frequency of skin irritation at site monitored after patch removal<br>* Clinically important changes in Vital signs monitored twice daily throughout the in-house period <br>* Clinically important changes in laboratory tests and assessments monitored at screening, check-in, Day 4, discharge and follow up (5-7 days post discharge)]