A single and repeat patch application study to determine what the body does to oxycodone in combination with tocopheryl phosphate mix, when delivered through the skin using a patch.

Phase 1

Completed

• Conditions: To promote pain relief, tested in healthy volunteers.; Anaesthesiology - Pain management

• Registration Number: ACTRN12612000059864
• Lead Sponsor: Phosphagenics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-11
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

1. Participant is free from clinically significant illness or disease as determined by screening and check-in assessments
2. BMI is equal to or greater than 19 and is equal to or less than 27 kg/m2
3. Weight > 50kg
4. Adequate venous access for collection of a number of blood samples.

Exclusion Criteria

1. Evidence of any clinically significant impairment/disorder
2. History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease
3. Current use of CNS depressants
4. Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1
5. A calculated creatinine clearance of < 85ml/min
6. Positive HIV antibodies, Hep B surface antigen or Hep C antibody test
7. History of epilepsy or any convulsive disorder
8. Any pre-existing medical conditions predisposing the participant to hypoventilation or hypoxaemia including diagnosed obstructive sleep apnoea
9. Systolic BP of < 90 mmHg or >140 mmHg and/or diastolic BP of < 50 mmHg or >95 mmHg
10. Known intolerance to naltrexone, naloxone, oxycodone, or other opioid analgesics or any commercially available adhesives
11. Any history of a recurrent generalised skin disorder <5 yrs
12. Any tattoos, scars or skin lesions on the area of IP application
13. History/evidence of drug or alcohol abuse and/or positive urine/breath test
14. Not able to abstain from alcohol, caffeine, smoking or other xanthine-containing products
15. Smoked avg. of =1 cigarettes/tobacco per mth in last 12 mths
16. Use of any prescription medication, over the counter products, herbal product, diet aid, or hormone supplement 14 days prior to study dosing
17. Consumption of grapefruit products, or any products containing CYP3A4 inhibitors and inducers within 14 days prior to the first day of study confinement
18. Males and females of childbearing potential who are unwilling or unable to use an acceptable method of double barrier contraception
19. Pregnant or lactating females.

Study & Design

• Study Type: Interventional
• Study Design: Not specified