An open label, phase I study to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from multiple applications of a transdermal oxymorphone patch.

An open label, multiple dose, phase I study in healthy volunteers to determine the pharmacokinetic, safety and tolerability profiles of oxymorphone delivered from a transdermal oxymorphone patch to promote pain relief.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000932763

Acronym

POH032-13

Enrollment

Registered

2013-08-23

Start date

2013-08-23

Completion date

2013-09-04

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The purpose 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.

Interventions

Single centre, open-label, multiple application study in a total of 12 healthy participants. Eligible participants will receive 4 x 3 day sequential applications of transdermal patches containing 56.8 mg of oxymorphone per application in combination with TPM (tocopheryl phosphate mix) during a 12 day in-house stay. A subsequent 4 day in-house stay will follow to ensure washout of the oxymorphone to a safe level prior to discharge.During the entire study period, participants will receive naltre

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

Male

Age

18 Years to 55 Years

Healthy volunteers

Yes

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.

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 rested systolic blood pressure of < 90 mmHg or > 160 mmHg and/or diastolic blood pressure of < 50 mmHg or > 95 mmHg. * History of obstructive airway disease or any condition that may increase the risk for respiratory depression. * A resting pulse rate at rest of < 45 Beats Per Minute (BPM) or > 100 BPM. * History of neurologic conditions or convulsive disorders, 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 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 history of a dermatological condition or recurrent generalised skin disorder within the last 5 years. * 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.

Outcome results