Safety and Blood levels of DS1971, version1
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 and female subjects (15-019)
IRAS ID
185960
Contact name
Adeep Puri
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2015-002885-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
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 any side effects and blood levels of repeated doses of the study medicine and its breakdown products, and whether they affect levels of substances that breakdown medicines or how well the body gets rid of medicines. We will also test how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.
We’ll give up to 27 healthy men and women (in up to 3 groups of 9), aged 18–65 years, repeated doses of the study medicine (given by mouth) for 14 days. We plan to increase the dose as the study progresses. We’ll do that only if the previous dose caused no important side effects. Some participants will take dummy medicine (with no medicine in it) instead of the study medicine. Neither the participants nor we will know which treatment they’re taking.
Participants will take up to 7 weeks to finish the study. They’ll make 2 outpatient visits and will stay on the ward for 18 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.
REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/1229
Date of REC Opinion
2 Sep 2015
REC opinion
Further Information Favourable Opinion