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Trial registered on ANZCTR


Registration number
ACTRN12613000085774
Ethics application status
Approved
Date submitted
21/01/2013
Date registered
23/01/2013
Date last updated
5/04/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
An open label, single dose, phase I pilot study to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patch
Scientific title
An open label, single dose, phase I pilot study in healthy volunteers to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patch to promote pain relief.
Secondary ID [1] 281779 0
Phosphagenics' Study ID POH030-12
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. 288099 0
Condition category
Condition code
Anaesthesiology 288472 288472 0 0
Pain management

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Single centre, open-label, single application study in a total of 12 healthy participants.

Eligible participants will receive a single application (3 day, 72 hour application time) of a transdermal oxymorphone patch (containing 19.2 mg oxymorphone) with a subsequent 4 day washout period. The total duration of the intervention is 7 days.

Intervention code [1] 286324 0
Treatment: Drugs
Comparator / control treatment
Nil.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288633 0
To characterise the pharmacokinetic profile of oxymorphone delivered transdermally using the oxymorphone patch, assessed through collection of blood samples.
Timepoint [1] 288633 0
Pharmacokinetic profile will be assessed through collection of blood samples at various time points. On Day 1 there will be an intensive blood sampling period in which samples will be collected every 1-2hrs and for the duration of the in-house period sample will be collected every 4-8hrs. A total of 43 blood samples will be collected from each participant and analysed.
Secondary outcome [1] 300665 0
To evaluate the safety/tolerability of oxymorphone delivered transdermally from the oxymorphone patch.

Safety/tolerability will be assessed by:
* The frequency of Adverse Events
* The frequency of skin irritation at site
* Clinically important changes in Vital signs from baseline
* Clinically important changes in ECG measurements from baseline
* Clinically laboratory tests and assessments
Timepoint [1] 300665 0
Safety/tolerability will be assessed by:
* The frequency of Adverse Events measured daily throughout the duration of the stuy
* The frequency of skin irritation measured after removal of the patch
* Clinically important changes in Vital signs from baseline, measured 4 hourly throughout the in-house period
* Clinically important changes in ECG measurements from baseline, measured 6 - 12 hourly throughout the in-house period
* Clinically laboratory tests and assessments measured at baseline, day 4, discharge and f/up

Eligibility
Key inclusion criteria
* Participant is free from clinically significant illness or disease
*BMI is equal to or greater than 19 and is equal to or less than 27 kg/m2
* Weight > 50kg at Screening.
* Adequate venous access in both arms for collection of a number of blood samples.
* Male participants that are not surgically sterile (i.e. vasectomy) must be abstinent or agree to use effective barrier contraception (i.e., condom) during the study period.
Minimum age
18 Years
Maximum age
55 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Evidence of clinically significant impairment/disorders.
* History of coronary disease, peripheral vascular disease, cerebrovascular accident, transient ischaemic attack, uncontrolled hypertension or signs/symptoms of ischaemic heart disease.
* Have a seated systolic blood pressure of < 90 mmHg or >160 mmHg and/or diastolic blood pressure of < 50 mmHg or >95 mmHg at Screening or Check-In.
* History of acute or severe bronchial asthma, diagnosed obstructive sleep apnoea, hypoxia, hypoxaemia, hybercarbia, or other obstructive airway disease or any condition that may increase the risk for respiratory depression.
* A resting (seated for at least five minutes) pulse rate at rest of < 45 BPM or > 100 BPM at Screening or Check-In.
* History of neurologic conditions such as seizures or convulsive disorders (including epilepsy), severe head injury or increased intracranial pressure.
* A calculated creatinine clearance of < 85 mL/minute.
* Have undergone surgery or received anaesthetic within 30 days of Day 1.
* Use of CNS depressants including: other opioids, sedative, anxiolytics, hypnotics, neuroleptics, phenothiazines, tranquillisers, skeletal muscle relaxants, sedating antihistamines or cimetidine within 30 days of Day 1.
* Use of macrolide antibiotics (e.g., Erythromycin), azole antifungal agents (e.g., Ketoconazole) or protease inhibitors (e.g., Ritanovir) within 30 days of Day 1.
* Use of any prescription medication during the 14 days prior to Day 1 and for duration of study, unless approved by both the PI and the Medical Monitor (in writing).
* Use of any OTC product, herbal product, diet aid, or hormone supplement, within 14 days prior to Day 1 and for duration of study.
* Known intolerance, allergy or hypersensitivity reactions to naltrexone, naloxone, oxymorphone, opioid analgesics, or any commercially available adhesives.
* Any history of a dermatological condition or recurrent generalised skin disorder within the last 5 years including psoriasis and eczema or any other skin condition.
* Any tattoos, bruises, scars or skin lesions on the area where the IP is to be applied which may interfere with study assessments.
* Positive screening test for HIV antibodies, Hepatitis B surface antigen or Hepatitis C antibody.
* Evidence or history of substance or alcohol abuse (drink more than 2 standard units of alcohol per day), including positive test results for drugs of abuse in the urine or a positive alcohol breath test at Screening or at Check-In.
* Unwilling or unable to abstain from recreational drug/substance use, alcohol, caffeine or other xanthine-containing products from Day -1 until discharge.
* Participants who are not willing to refrain from smoking 48 hours before Day –1 until discharge.
* Consumption of grapefruit, grapefruit juice or any products containing CYP3A4 inhibitors and inducers within 14 days of Day 1 and through to completion of the confinement period.

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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Pharmacokinetics
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment postcode(s) [1] 6177 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 286561 0
Commercial sector/Industry
Name [1] 286561 0
Phosphagenics Limited
Address [1] 286561 0
11 Duerdin Street Clayton, Victoria 3168
Country [1] 286561 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Phosphagenics Limited
Address
11 Duerdin Street Clayton, Victoria 3168
Country
Australia
Secondary sponsor category [1] 285346 0
None
Name [1] 285346 0
Address [1] 285346 0
Country [1] 285346 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288629 0
Bellberry Limited
Ethics committee address [1] 288629 0
229 Greenhill Road Dulwich South Australia 5065
Ethics committee country [1] 288629 0
Australia
Date submitted for ethics approval [1] 288629 0
Approval date [1] 288629 0
Ethics approval number [1] 288629 0

Summary
Brief summary
The purose of this study is to understand how well oxymorphone 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 37070 0
Dr Sepehr Shakib
Address 37070 0
CMAX, Level 5, East Wing, Royal Adelaide Hospital, North Terrace, Adelaide SA 5000, AUSTRALIA
Country 37070 0
Australia
Phone 37070 0
+61 8 8222 3923
Fax 37070 0
Email 37070 0
Alison.Monkhouse@cmax.com.au
Contact person for public queries
Name 37071 0
Ms Alisha Smith
Address 37071 0
11 Duerdin Street, Clayton VIC 3168
Country 37071 0
Australia
Phone 37071 0
+61 3 9565 1119
Fax 37071 0
Email 37071 0
asmith@phosphagenics.com
Contact person for scientific queries
Name 37072 0
Ms Alisha Smith
Address 37072 0
11 Duerdin Street, Clayton VIC 3168
Country 37072 0
Australia
Phone 37072 0
+61 3 9565 1119
Fax 37072 0
Email 37072 0
asmith@phosphagenics.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary