Comparing blood levels of DS-1971a when taken as a liquid or a tablet
Research type
Research Study
Full title
A Phase 1, open-label, randomised, single-dose, 3-way crossover study to explore the relative bioavailability of DS-1971a given as a 200 mg tablet formulation and a 200 mg oral suspension, and to explore the effects of administration with a high-fat meal on the relative bioavailability of the tablet formulation (HMR code: 14-024, version 1)
IRAS ID
164041
Contact name
Adeep Puri
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2014-003662-24
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 8 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. Those medicines also have troublesome side effects, particularly dizziness and drowsiness. We hope that DS-1971a will prevent pain when given alone, without causing troublesome side effects.
In this study, we'll compare 2 different forms of DS-1971a: an existing liquid form (called a suspension), and a new tablet form that will be used in future studies in patients. We'll test whether:
* blood levels of DS-1971a are similar when it’s taken as tablets and as a liquid
* food affects absorption of DS 1971a into the bloodstream when it’s taken as tablets
We’ll also assess the side effects of DS 1971a tablets, and we may test how genes (pieces of DNA) affect the way the body responds to or handles DS-1971a.We’ll study 18 healthy men and women, aged 18–65 years. They’ll have 3 study sessions, and they’ll take a single dose of 200 mg DS–1971a in each session, as follows: 1 dose as a liquid after an overnight fast; 1 dose as a tablet after an overnight fast; and 1 dose as a tablet after a fatty breakfast.
Participants will take about 8 weeks to finish the study. They’ll make 2 outpatient visits and will stay on the ward for 4 nights in a row in each study session (12 nights in total).
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
14/LO/1656
Date of REC Opinion
22 Oct 2014
REC opinion
Favourable Opinion