Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000514000
Ethics application status
Approved
Date submitted
21/05/2010
Date registered
22/06/2010
Date last updated
12/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
A repeat patch application study to determine what the body does to oxycodone in combination with tocopheryl phosphate mix, when delivered through the skin using different methods of repeat application.
Scientific title
A phase Ib repeat patch application study to determine the pharmacokinetic and safety profiles of transdermally delivered oxycodone in combination with the novel penetration enhancer tocopheryl phosphate mix (TPM) using different methods of repeat application in healthy male volunteers.
Secondary ID [1] 251835 0
Phosphagenics' Study ID POH025-10
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To promote pain relief, tested in healthy volunteers. 257435 0
Condition category
Condition code
Anaesthesiology 257582 257582 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256534 0
Treatment: Drugs
Comparator / control treatment
All four test groups will be compared
Control group
Active

Outcomes
Primary outcome [1] 258502 0
To compare the pharmacokinetics of transdermally delivered oxycodone from the tocopheryl phosphate mix (TPM) matrix patch system using various dosing regimes.
Timepoint [1] 258502 0
Blood samples for pharmacokinetic assessment will be collected within 15 minutes prior to dosing and at the following times thereafter: 6, 12, 18, 24, 30, 36, 42, 48, 54, 60, 66, 72, 78, 84, 90, 96, 102, 108, 114, 120, 126, 132, 138, 144, 150, 156, 162, 168, 174, 180, 186, 192, 198, 204, 210, 216, 222, 228, 234, 240, 246, 252, 258, 264, 270, 276, 282, 288, 294, 300, 306, 312, 318, 324, 330, 336, 344, 352, 360, 368, 376, 384, 392, 400, 408, 416, 424 and 432 hours post first patch application.
Secondary outcome [1] 264299 0
To evaluate the safety and tolerability of transdermally delivered oxycodone in a novel formulation containing tocopheryl phosphate mix (TPM) using various dosing regimes.
Timepoint [1] 264299 0
Biochemistry, haematology and urinalysis will be performed for safety assessments on Day -1 (baseline), day 5, day 10, day 14 and day 19.
Vital signs will be measured approximately 30 minutes prior to the first patch application and at 6, 12, 24,36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, 192, 204, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408, 420 and 432 hours post first patch application.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
49 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257171 0
Commercial sector/Industry
Name [1] 257171 0
Phosphagenics Limited
Country [1] 257171 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 256430 0
None
Name [1] 256430 0
Address [1] 256430 0
Country [1] 256430 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259038 0
Ethics committee address [1] 259038 0
Ethics committee country [1] 259038 0
Date submitted for ethics approval [1] 259038 0
18/05/2010
Approval date [1] 259038 0
Ethics approval number [1] 259038 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31205 0
Address 31205 0
Country 31205 0
Phone 31205 0
Fax 31205 0
Email 31205 0
Contact person for public queries
Name 14452 0
Yelda Ogru
Address 14452 0
11 Duerdin Street
Clayton, Victoria 3168
Country 14452 0
Australia
Phone 14452 0
+61 3 95651156
Fax 14452 0
Email 14452 0
[email protected]
Contact person for scientific queries
Name 5380 0
Yelda Ogru
Address 5380 0
11 Duerdin Street
Clayton, Victoria 3168
Country 5380 0
Australia
Phone 5380 0
+61 3 95651156
Fax 5380 0
Email 5380 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.