A phase I study to determine the tolerability and safety of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM).
- Conditions
- To promote pain relief in healthy volunteers.Anaesthesiology - Pain management
- Registration Number
- ACTRN12609000836235
- Lead Sponsor
- Phosphagenics Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Male
- Target Recruitment
- 44
Body Mass Index (BMI) must be greater than or equal to 19 and less than or equal to 30 kg/m2.
- Weight must be greater than 50kg
History or evidence of drug and/or alcohol abuse; smokers; use of central nervous system (CNS) depressants, other opioids, sedative/hypnotics, phenothiazines, tranquillisers, skeletal muscle relaxants or sedating antihistamines; 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; Evidence of clinically relevant oral, cardiovascular, haematological, gastrointestinal, hepatic, renal, endocrine, pulmonary, neurologic, psychiatric or skin disorders; History of epilepsy, coronary disease, peripheral vascular diseases, cerebrovascular accident, transient ischaemic attack; uncontrolled hypertension or signs/symptoms of ischaemic heart disease; Any pre-existing medical conditions predisposing the subject to hypoventilation or hypoxaemia; 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 (i.e., disodium tocopheryl phosphate (TP), sodium di-tocopheryl phosphate (T2P), pemulen gel, triethanolamine, methylparaben); Known allergy or hypersensitivity to lidocaine or Tegaderm(registered trademark) patches or to topical preparations, such as sunscreens; A calculated creatinine clearance (CL) of < 85ml/min; Positive screening test for Human Immunodeficiency Virus (HIV) antibodies, Hepatitis B surface antigen or Hepatitis C antibody; Have a history of low blood pressure (BP) or severe motion sickness e.g., hypotension where BP is persistently < 90/50 mmHg; 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the tolerability and safety of oxycodone in novel formulations containing TPM.<br>This will be assessed by regular vital sign checks, and participants will be asked if they are experiencing any Adverse Events throughout the duration of the study.<br>Some adverse events that may be associated with the study drug include; confusion, dizziness, drowsiness, restlessness, mood changes, impaired breathing, decreased frequency in passing urine and decreased urine volume, abdominal pain, constipation, loss of appetite, dry mouth, vomiting, headache, sweating, flushing, itching of skin, pupil constriction, slow heart rate, low blood pressure, faintness and in severe cases circulatory failure and respiratory and cardiac arrest.[During Screening, Dosing Period and Follow-Up visit (10-14 days after participant has checked out from clinic).<br>This outcome will be monitored continuously throughout the entire duration of the study.]
- Secondary Outcome Measures
Name Time Method To compare the relative bioavailability of a gel, reservoir and matrix system containing TPM compared to a commercially available tablet.<br>This will be assessed through blood and urine sampling/analyses.[Blood samples will be collected within 15 minutes prior to dosing (0hr) and at the following times thereafter for groups 1, 2 and 3: 0, 1, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 82, 94, 106, 118, 130, 142 and 154 hours post-dose. For group 4 blood samples will be collected pre-dose and at 0.5, 1, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 20, 24, 28, 32, 36, 40, 44, 48, 50, 52, 54, 56, 60, 64, 72 and 96 hours post-dose. A maximum of 29 blood samples will be collected from each subject during the entire study.<br><br>10mL samples of every urinary output will be collected, including a pre-dose sample, and the total urine volume at each urinary output will be recorded.]