Effect of lorazepam on side effects & blood levels of DS-5565; ver 1
Research type
Research Study
Full title
A phase 1, randomised, double-blind, placebo-controlled, four-way crossover study to assess the potential pharmacokinetic and pharmacodynamic interaction between DS-5565 and lorazepam.
IRAS ID
98249
Contact name
Malcolm Boyce
Sponsor organisation
Daiichi Sankyo Development Ltd (DSD)
Eudract number
2011-006046-33
ISRCTN Number
n/a
Research summary
DS-5565 is an experimental treatment for neuropathic pain, which is pain caused by damage to nerves. We hope that the study medicine will work by stopping nerves from sending inappropriate pain messages to the brain. Lorazepam is a medicine used to treat anxiety and to help People'sleep. Patients might well need to take lorazepam with DS-5565 in the future, so we need to know it??s safe to give the 2 medicines together. We're doing this study to find out if taking DS-5565 with lorazepam causes more side effects or affects the way the body handles either of those medicines. 20 healthy men and women (aged 18??55 years) will each have 4 study sessions. They??ll take the following treatments: DS-5565 alone (twice-daily for 2 days); DS-5565 and a single dose of lorazepam; lorazepam alone; and dummy medicine. If participants consent, also take a blood sample that might be used to study how genes (pieces of DNA) affect the way the body responds to or handles DS-5565. Participants will take up to 9 weeks to finish the study. They??ll make 2 outpatient visits, and stay on the ward for 4??5 nights in each study session. A pharmaceutical company (Daiichi Sankyo Development Ltd) is funding the study. The study will take place at 1 centre in London. We'll recruit healthy participants by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites.
REC name
London - Brent Research Ethics Committee
REC reference
12/LO/0109
Date of REC Opinion
7 Feb 2012
REC opinion
Favourable Opinion