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Trial registered on ANZCTR


Registration number
ACTRN12612000059864
Ethics application status
Approved
Date submitted
11/01/2012
Date registered
11/01/2012
Date last updated
23/02/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
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.
Scientific title
A two part, open label, phase I single and repeat Investigational Product application study in healthy volunteeers, to determine the pharmacokinetic, safety and tolerability profiles of oxycodone delivered from a transdermal TPM/O patch.
Secondary ID [1] 279706 0
None
Universal Trial Number (UTN)
Trial acronym
Phosphagenics' Study ID POH028-11
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To promote pain relief, tested in healthy volunteers. 285541 0
Condition category
Condition code
Anaesthesiology 285732 285732 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study has a single (PART 1) and repeat (PART 2) application component.

PART 1 will consist of three groups of 15 participants, each receiving a single application of a TPM/O Investigational Product. Participants will be enrolled to receive a single application of one of three dosing regimes (2 type A patches, 3 type A patches or 3 type B patches) that will be applied for 3 days with a subsequent 3 days in-house during which time participants will be monitored while the TPM/O is washed out. Participants will stay in-house for a total of 7 days.

Results from PART 1 will be analysed to determine the dose selected for repeat dosing.

Participants that undertake the single application part, will not be eligible to participate in the repeat application part.

PART 2 will consist of one cohort of 20 participants each receiving repeat applications of the selected TPM/O. Participants will receive 7 applications of TPM/O that will be applied every 3 days for a total of 21 days with a subsequent 6 days in-house during which time participants will be monitored while the TPM/O is washed out. Participants will stay in-house for a total of 28 days.

Two patches (patch A and B) will be tested with differing strengthes of oxycodone and excipients. Participants will have either 2 or 3 patches applied by a member of the unit staff to the upper torso area. The patch will remain on the skin for 3 days
Intervention code [1] 284003 0
Treatment: Drugs
Comparator / control treatment
PART 1 (single application): will consist of three groups of 15 participants, each receiving a parallel single application of one of three dosing regimes (2 type A patches, 3 type A patches or 3 type B patches).

PART 2 (repeat application): will consist of one group of 20 participants each receiving repeat applications of the selected TPM/O patch.
Control group
Dose comparison

Outcomes
Primary outcome [1] 286261 0
To characterise the pharmacokinetic profiles of oxycodone delivered transdermally using TPM/O patches in various dosing regimes.
Timepoint [1] 286261 0
Pharmacokinetic profile will be assessed through collection of blood samples at various time points during each 3 day patch application and during the wash out period.

A total of 40 blood samples will be collected from each participant and analysed in PART 1 (single application). The blood samples will be collected prior to patch application and then at the following times points 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 28, 32, 36, 40, 48, 52, 56, 60, 64, 72, 74, 76, 80, 84, 88, 96, 104, 112, 120, 128, 136 and 144 hours post dose.

A total of 70 blood samples will be collected from each participant and analysed in PART 2 (repeat application). The blood samples will be collected prior to patch application and then at the following times points 8, 12, 16, 24, 32, 40, 48, 56, 64, 72, 76, 80, 88, 96, 104, 112, 120, 128, 136, 144, 148, 152, 156, 160, 168, 176, 184, 192, 200, 208, 216, 228, 240, 252, 264, 276, 288, 300, 312, 324, 336, 348, 360, 372, 384, 396, 408, 420, 432, 444, 456, 468, 480, 492, 504, 508, 512, 516, 520, 528, 536, 544, 552, 564, 576, 588, 600, 624 and 648 hours post dose.
Secondary outcome [1] 295462 0
To evaluate the safety and tolerability of transdermally delivered oxycodone from TPM/O patches using various dosing regimes.
Timepoint [1] 295462 0
The safety and tolerability of transdermally delivered oxycodone from TPM/O patches will be determined by collection and assessoment of the following parameters;
- laboratory samples: will be collected at screening, check-in, on-study (every 3 to 6 days) and follow up visit.
- vital signs: will be assessed at screening, during check-in and eligibility confirmation, prior to patch application, 6hrs after patch application and then at 12hr intervals until discharge. Vital will also be assessed at the follow up visit.
- ECGs: will be collected at screening, check-in, and follow up visit.
- physical examination: will be collected at screening, check-in, Day 1, discharge and follow up visit.
- skin irritation: will be assessed after each patch has been removed.
- patch adhesion: will be assessed daily
- participants will be regularly questioned regarding any changes experienced in their health and administration of any concomitant mediation.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will be sequentially assigned to a treatment group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequential assignment to a treatment group.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/11/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
65
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284487 0
Commercial sector/Industry
Name [1] 284487 0
Phosphagenics Limited
Country [1] 284487 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street
Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 283411 0
None
Name [1] 283411 0
Address [1] 283411 0
Country [1] 283411 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286469 0
Bellberry Limited
Ethics committee address [1] 286469 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 286469 0
Australia
Date submitted for ethics approval [1] 286469 0
Approval date [1] 286469 0
17/11/2011
Ethics approval number [1] 286469 0
2011-10-502-A-2

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33616 0
Address 33616 0
Country 33616 0
Phone 33616 0
Fax 33616 0
Email 33616 0
Contact person for public queries
Name 16863 0
Alisha Smith
Address 16863 0
11 Duerdin Street
Clayton, Victoria 3168
Country 16863 0
Australia
Phone 16863 0
+61 (0)3 9565 1156
Fax 16863 0
Email 16863 0
asmith@phosphagenics.com
Contact person for scientific queries
Name 7791 0
Alisha Smith
Address 7791 0
11 Duerdin Street
Clayton, Victoria 3168
Country 7791 0
Australia
Phone 7791 0
+61 (0)3 9565 1156
Fax 7791 0
Email 7791 0
asmith@phosphagenics.com

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

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