None listed
Conditions
Brief summary
The purose of this study is to understand how well Oxycodone in combination with tocopheryl phosphate mix (TPM), is absorbed through the skin and into the bloodstream, with the use of a patch.
Interventions
The study consists of four test groups.
1. Daily application of a matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone applied to the same site on the upper right or left thigh every day for 14 days.
2. Daily application of a matrix patch system containing 40mg TPM and 200mg Oxycodone, rotating the application between two sites on the upper right or left thigh every day for 14 days.
3. Daily application of a matrix patch system containing 20mg TPM and 100mg Oxyc
The study consists of four test groups. 1. Daily application of a matrix patch system containing 40mg Tocopheryl Phosphate Mix (TPM) and 200mg Oxycodone applied to the same site on the upper right or left thigh every day for 14 days. 2. Daily application of a matrix patch system containing 40mg TPM and 200mg Oxycodone, rotating the application between two sites on the upper right or left thigh every day for 14 days. 3. Daily application of a matrix patch system containing 20mg TPM and 100mg Oxycodone applied to the same site on the upper right or left thigh every day for 14 days. 4. Weekly application of a matrix patch system containing 40mg TPM and 200mg Oxycodone to the same site on the upper right or left thigh for 2 weeks.
Sponsors
Phosphagenics Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
Male
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
1. Male and aged 18 to 49 years (inclusive). 2. Healthy subjects - defined as individuals who are free from clinically significant illness or disease as determined by their medical history, physical examination, electrocardiograph and clinical laboratory determinations. 3. Body mass index (BMI) greater than or equal to 19 and less than or equal to 30 kg/m2. 4. Weight is greater than 50 kg. 5. Adequate venous access in the left or right arm to allow collection of a number of blood samples. 6. Fluent in the English language. 7. Able to provide written informed consent to participate in the study and be willing to comply with the study procedures.
Exclusion criteria
1. History or evidence of drug abuse and/or positive repeat urine results prior to start of the study. History or evidence of alcohol abuse and/or positive repeat urine/breath test results prior to start of the study. 2. Individuals who smoked an average of one or more cigarette or tobacco form (including cigars) per month in the last 12 months. 3. Current use of central nervous system (CNS) depressants including: other opioids, sedative/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines. 4. Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritanovir) within 30 days of study dosing. 5. Evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorders. 6. History of epilepsy. 7. History of coronary diseases, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease e.g., Hypertension where blood pressure (BP) is persistently greater than 140/95 mmHg. 8. Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia. 9. Known allergy or hypersensitivity reactions to naltrexone or to oxycodone, or other opioid analgesics (codeine, fentanyl, hydrocodone, morphine etc.), or allergy to any contents of the gel or patch materials. 10. Known allergy or hypersensitivity to Tegaderm patches or to topical preparations, such as sunscreens. 11. A calculated creatinine clearance (CL) of less than 85ml/min. 12. Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody. 13. Use of any prescription medication during the 14 days prior to study dosing, unless approved by both the Principal Investigator (PI) and the Sponsor. If necessary, paracetamol (acetaminophen) may be received for mild analgesia prior to, or during, the study. 14. Use of any over the counter product, herbal product, diet aid, hormone supplement, etc., within 14 days prior to dosing unless approved by both the PI and the Sponsor. 15. Have participated in a clinical trial or receipt of an experimental therapy within 30 days prior to dosing, other than subjects who undertook the Naltrexone challenge successfully as alternates for earlier cohorts of this study. 16. Blood donation of greater than 550 mL within 90 days before the first dose administration. 17. Have a history of low BP or severe motion sickness e.g., hypotension where BP is persistently less than 90/50 mmHg. 18. Consumption of grapefruit or grapefruit juice within 14 days prior to the first day of study confinement and through to completion of the confinement period. 19. Regularly drink more than four (4) units of alcohol daily (1 unit = 300 mL beer, 1 glass of wine, 1 measure of spirit) or who may have difficulty abstaining from alcohol during the 36 hours prior to dose administration and until completion of blood sampling. 20. Any tattoos on the area where the study drug is to be applied.
Outcome results
None listed