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.

Exclusion Criteria15

• 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.