MR30507/09 analgesic response study
Research type
Research Study
Full title
A double-blind, randomised, single-dose, crossover study to compare the safety, tolerability and pharmacokinetic/pharmacodynamic profile of MR30507/09 with MR30365/07, fentanyl and placebo in healthy subjects.
IRAS ID
138753
Contact name
Annelize Koch
Contact email
Sponsor organisation
Mundipharma Research Limited
Eudract number
2013-000392-32
Research summary
The new medicines to be tested in this study are compounds MR30307/09 and MR30365/07.
Mundipharma is examining the properties of the study drugs with the aim of developing the study drugs for treating severe pain. This study will compare the study drugs to a similar product already on the market.
The main purpose of the study is to evaluate how effective MR30307/09 and MR30365/07 are in reducing pain, to see how safe (safety) they are and how well they are tolerated after dosing (tolerability). The study will also investigate how the study drugs are taken up, metabolised (chemically broken down), distributed through the body and excreted (pharmacokinetics and pharmacodynamics). The study will also try to understand why different people respond differently to the same drug through DNA testing (pharmacogenetics).
This study will be performed at the PAREXEL Early Phase Clinical Unit (London), Northwick Park Hospital, Watford Road, Harrow, HA1 3UJ.
Approximately 32 healthy male participants will be enrolled in this study. They will be equally divided into 4 treatment groups; each group will receive a single dose of each treatment in a randomised order. Participants will be assigned a different treatment in each study period. Doses of each treatment will increase in each study period, following review of safety data from the previous period.
Safety such as vital signs, pulse oximetry, ECGs, physical exams, laboratory safety tests and adverse events as well as concomitant medications will be monitored throughout the entire investigational period.
REC name
East of England - Cambridgeshire and Hertfordshire Research Ethics Committee
REC reference
13/EE/0342
Date of REC Opinion
18 Nov 2013
REC opinion
Further Information Favourable Opinion