Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000613606
Ethics application status
Approved
Date submitted
2/06/2014
Date registered
6/06/2014
Date last updated
9/12/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase I, open label, randomised, single dose, two-way crossover study to determine the pharmacokinetics of two transdermal oxymorphone patch formulations.
Scientific title
A Phase I, open label, randomised, single dose, two-way crossover study in healthy volunteers to determine the pharmacokinetics of two transdermal oxymorphone patch formulations to promote pain relief.
Secondary ID [1] 284689 0
Nil
Universal Trial Number (UTN)
Trial acronym
POH037-13
Linked study record

Health condition
Health condition(s) or problem(s) studied:
To promote pain relief, tested in healthy volunteers. 292043 0
Condition category
Condition code
Anaesthesiology 292379 292379 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single centre, open-label, single dose crossover study testing two oxymorphone transdermal patch formulations in a total of 15 healthy participants. The two formulations contain different patch excipients/ingredients.

Eligible participants will receive 2 x 3 day applications of transdermal patches containing 56.8 mg of oxymorphone per application in combination with TPM (tocopheryl phosphate mix) with a 4 day washout period between applications. A subsequent 4 day in-house stay will follow to ensure washout of the oxymorphone to a safe level prior to discharge, in total subjects will remain in clinic for approximately 15 days.

During the entire study period, participants will receive naltrexone 50mg orally twice a day to block the systemic effects of oxymorphone.
Intervention code [1] 289478 0
Treatment: Drugs
Comparator / control treatment
Two formulations will be tested to investigate different patch excipients/ingredients; each participant will have both patches applied with a washout period in between
Control group
Active

Outcomes
Primary outcome [1] 292237 0
To determine the single dose PK profiles of oxymorphone delivered transdermally from two oxymorphone patch formulations, and of the active metabolite.
Timepoint [1] 292237 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 43 blood samples will be collected from each participant and analysed
Secondary outcome [1] 308507 0
To evaluate the systemic exposure to the two primary excipients of the oxymorphone patch.
Timepoint [1] 308507 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 43 blood samples will be collected from each participant and analysed
Secondary outcome [2] 308508 0
To evaluate the single dose safety and tolerability of oxymorphone delivered transdermally from two experimental patch formulations.
Timepoint [2] 308508 0
* The frequency of AEs * The frequency of skin irritation at site * Clinically relevant changes in vital signs * Clinically relevant changes in laboratory tests and assessments monitored at screening, check-in, Day 4, Day 11, discharge and follow up (5-7 days post discharge)

Eligibility
Key inclusion criteria
Healthy male subjects, aged 18 to 55 years inclusive, body mass index greater than or equal to 19 and less than or equal to 27 kg/m2, weight >50 kg, free from clinically significant illness or disease, as defined. 3. Free from current, recurrent or history (< 5 years) of a significant dermatological condition or generalized skin disorder.
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
* Have a rested systolic blood pressure of < 90 mmHg or > 160 mmHg and/or diastolic blood pressure of < 50 mmHg or > 95 mmHg or radial pulse rate at rest of < 45 beats per minute (bpm) or > 100 bpm
* History of obstructive airway disease or any condition that may increase the risk for respiratory depression.
* History of neurologic conditions or convulsive disorders, severe head injury or increased intracranial pressure.
* A calculated creatinine clearance of < 85 mL/minute
* Evidence of clinically significant impairment/disorders.
* Have undergone surgery or received anaesthetic within 30 days of Day 1.
* Use of central nervous system depressants within 30 days of Day 1.
* Use of macrolide antibiotics, azole antifungal agents or protease inhibitors within 30 days of Day 1.
* Use of any prescription medication, over the counter product, herbal product, diet aid, or hormone supplement, within 14 days of Day 1 and for duration of study.
* Known intolerance any ingredients in the patch, naltrexone or naloxone.
* Any tattoos, bruises, scars or skin lesions on the area where the patch is to be applied.
* Consumption of grapefruit, grapefruit juice or any products containing CYP3A4 inhibitors and inducers within 14 days of Day 1 and through to discharge.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
9/06/2014
Actual
16/06/2014
Date of last participant enrolment
Anticipated
Actual
24/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 289316 0
Commercial sector/Industry
Name [1] 289316 0
Phosphagenics Limited
Country [1] 289316 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 287987 0
None
Name [1] 287987 0
Address [1] 287987 0
Country [1] 287987 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291079 0
Bellberry
Ethics committee address [1] 291079 0
Ethics committee country [1] 291079 0
Australia
Date submitted for ethics approval [1] 291079 0
Approval date [1] 291079 0
28/05/2014
Ethics approval number [1] 291079 0

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

Contacts
Principal investigator
Name 48794 0
A/Prof Janakan Krishnarajah
Address 48794 0
Linear, 1st Floor, B Block, Hospital Avenue, Nedlands WA 6009
Country 48794 0
Australia
Phone 48794 0
+61 (0) 8 6382 5100
Fax 48794 0
Email 48794 0
[email protected]
Contact person for public queries
Name 48795 0
Alisha Smith
Address 48795 0
Phosphagenics Ltd, 11 Duerdin Street, Clayton VIC 3168
Country 48795 0
Australia
Phone 48795 0
+61 3 9565 1119
Fax 48795 0
Email 48795 0
[email protected]
Contact person for scientific queries
Name 48796 0
Alisha Smith
Address 48796 0
Phosphagenics Ltd, 11 Duerdin Street, Clayton VIC 3168
Country 48796 0
Australia
Phone 48796 0
+61 3 9565 1119
Fax 48796 0
Email 48796 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
SourceTitleYear of PublicationDOI
EmbaseA Phase i study of the pharmacokinetics, safety and tolerability of a novel tocopheryl phosphate mixture/oxymorphone transdermal patch system.2017https://dx.doi.org/10.2217/pmt-2017-0032
N.B. These documents automatically identified may not have been verified by the study sponsor.