Effects of age, gender and race on blood levels of DS-1971a, v1
Research type
Research Study
Full title
A phase I, open label, single dose, parallel group, exploratory study to assess the effects of age, gender and race on the pharmacokinetics of DS–1971a (HMR code: 14-013)
IRAS ID
162180
Contact name
Adeep Puri
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2014-003019-13
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 of the medicines. 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.
We’re doing this study to find out if age, gender, or race affect the way the body handles DS–1971a. We’ll assess and compare the blood levels and side effects of DS–1971a in young Japanese men, young and older Caucasian men, and young Caucasian women who are unable to have a baby. We may also test how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.
We’ll study 48 healthy participants: 12 Japanese men, aged 18–55 years; 12 Caucasian men, aged 18–55 years; 12 Caucasian men, aged 65 years or older; and 12 Caucasian women, aged 18–55 years. All participants will take a single dose of 200 mg DS–1971a.
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/1362
Date of REC Opinion
27 Aug 2014
REC opinion
Favourable Opinion