First study of DS-1971a in humans; version 1
Research type
Research Study
Full title
A phase 1, double-blind, randomized, placebo-controlled single ascending dose study to assess safety, tolerability and pharmacokinetics of DS-1971a in healthy male subjects. (HMR code: 13-020)
IRAS ID
150173
Contact name
Malcolm Boyce
Contact email
Eudract number
2014-000240-15
ISRCTN Number
xx
Clinicaltrials.gov Identifier
xx
Research summary
DS-1971a (the study medicine) is an experimental treatment for pain caused by damage to the nerves (neuropathic pain). We hope that the study medicine will work by stopping nerves from sending pain messages to the brain. There are other medicines that do that, but they often don’t work when given alone, so most patients are given a combination of the medicines. Those medicines also have troublesome side effects, particularly dizziness and drowsiness. We hope that the study medicine will prevent pain when given alone, without causing troublesome side effects.
We’re doing this study to find out the side effects and blood levels of the study medicine, and if the body breaks down the study medicine into substances called metabolites. We may also test how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.
We’ll give 64 healthy men, aged 18–45 years, single doses of the study medicine (given by mouth). The study medicine has never been given to humans before, so we’ll start with a low dose, and increase it as the study progresses. Some participants will take dummy medicine instead of the study medicine. Neither the participants nor we will know which treatment they’re taking.
Participants will take about 5 weeks to finish the study. They’ll make 2 outpatient visits and will stay on the ward for 4 nights in a row.
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
14/LO/0205
Date of REC Opinion
28 Feb 2014
REC opinion
Favourable Opinion