A Phase I, open label, randomised, single dose, two-way crossover study to determine the pharmacokinetics of two transdermal oxymorphone patch formulations.
- Conditions
- Anaesthesiology - Pain managementTo promote pain relief, tested in healthy volunteers.
- Registration Number
- ACTRN12614000613606
- Lead Sponsor
- Phosphagenics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 15
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. 3.Free from current, recurrent or history (< 5 years) of a significant dermatological condition or generalized skin disorder.
* 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 or radial pulse rate at rest of < 45 beats per minute (bpm) or > 100 bpm
* History of obstructive airway disease or any condition that may increase the risk for respiratory depression.
* History of neurologic conditions or convulsive disorders, severe head injury or increased intracranial pressure.
* A calculated creatinine clearance of < 85 mL/minute
* Evidence of clinically significant impairment/disorders.
* 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 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 determine the single dose PK profiles of oxymorphone delivered transdermally from two oxymorphone patch formulations, and of the active metabolite.[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 43 blood samples will be collected from each participant and analysed]
- Secondary Outcome Measures
Name Time Method To evaluate the systemic exposure to the two primary excipients of the oxymorphone patch.<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 43 blood samples will be collected from each participant and analysed];To evaluate the single dose safety and tolerability of oxymorphone delivered transdermally from two experimental patch formulations.[* The frequency of AEs<br>* The frequency of skin irritation at site <br>* Clinically relevant changes in vital signs <br>* Clinically relevant changes in laboratory tests and assessments monitored at screening, check-in, Day 4, Day 11, discharge and follow up (5-7 days post discharge)<br>]