MR30365/07 transdermal delivery system (TDS) pilot study
Research type
Research Study
Full title
An open-label, dose-ascending, single-period, single-dose pilot study to assess the safety, tolerability and pharamcokinetic profile of MR30365/07 in a transdermal delivery system in healthy subjects.
IRAS ID
134054
Contact name
David Bell
Contact email
Sponsor organisation
Mundipharma Research Ltd
Eudract number
2013-001316-30
Research summary
An open-label, dose-ascending, single-period, single-dose pilot study to assess the safety, tolerability and pharmacokinetic profile of a transdermal skin patch delivery system in healthy male subjects aged 18 to 45.
Six groups of 6 subjects will receive the study drug in a 7-day patch formulation applied to the skin on the upper back. The study drug is an opioid drug for the treatment of chronic pain. The effects of the study drug in humans are not yet known from a patch formulation, therefore it is expected that dosing under naltrexone cover will allow tolerability to be assessed for the entire patch wear duration, and for complete PK profiles to be collected in as many subjects as possible.
Each new group will be given a higher dose in the form of additional patches or part patches, the dose will be determined by review of data from each previous group. The maximum dose level will be 6 patches to wear for 7 days.
Subjects will be confined to the study unit from check-in on the day before study drug administration (Day -1) until post-dose assessments (pharmacokinetic and safety measurements) are completed at 192 hours after patch application (Day 9). Subjects will return to the study unit at 204 and 216 hours (Day 9 evening and Day 10 morning) for final post-dose assessments.
Safety will be assessed by documentation of spontaneously reported adverse events, clinical laboratory results, vital signs, physical examinations, pulse oximetry (SpO2) & questionnaires, duration of patch wear observations and 12-lead ECGs.
All subjects will return to the study unit for a post-study medical visit 7 days from patch removal. Subjects who receive naltrexone but no study drug will have a post-study medical before discharge from the study unit.
During confinement in the unit, subjects will receive standardised meals.REC name
HSC REC A
REC reference
13/NI/0086
Date of REC Opinion
8 Jul 2013
REC opinion
Further Information Favourable Opinion