Safety and blood levels of DS-1971a;version 1
Research type
Research Study
Full title
A Phase I, double-blind, randomised, placebo-controlled, multiple-dose study to assess safety, tolerability and pharmacokinetics of DS-1971a in healthy male subjects (14-011)
IRAS ID
158115
Contact name
Adeep Puri
Contact email
Eudract number
2014-001800-23
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 repeated doses of the study medicine, if the body breaks down the study medicine into substances called metabolites, and whether the study medicine affects levels of a substance that breaks down medicines. We may also test how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.
We’ll give 48 healthy men (in 6 groups of 8), aged 18–55 years, repeated doses of the study medicine (given by mouth) for 14 days. We’ll start with a low dose, and plan to 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 7 weeks to finish the study. They’ll make 2 outpatient visits and will stay on the ward for 17 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 - Harrow Research Ethics Committee
REC reference
14/LO/0878
Date of REC Opinion
16 Jun 2014
REC opinion
Favourable Opinion