Safety, blood levels & effects of DS-1040b taken with aspirin;version1
Research type
Research Study
Full title
A phase 1, open label, single dose study, to assess the safety and tolerability of a single IV dose of DS-1040b after 5 days of aspirin treatment in healthy subjects (HMR code: 13-015)
IRAS ID
143146
Contact name
Adeep Puri
Contact email
Eudract number
2013-003840-21
ISRCTN Number
n/a
Clinicaltrials.gov Identifier
Research summary
The study medicine is an experimental treatment to reduce the effects of a stroke in the brain. Strokes are caused by blood clots which block the blood flow to the brain and the affected areas stop working.
Patients with stroke are usually given medicines that dissolve blood clots, medicines that prevent clotting, and aspirin, which makes the blood less likely to clot. The study medicine works in a new way that should make blood clots more sensitive to the natural substances and medicines that dissolve them.
Many people who are at high risk of stroke take aspirin. So, we need to make sure that it’s safe to take the study medicine with aspirin. We aim to find out the study medicine’s side effects, blood levels, and effects on substances linked to blood clotting, when it’s taken with aspirin. We’ll study how long blood takes to clot (bleeding time), when the study medicine is taken with aspirin, because aspirin, and possibly the study medicine, increase bleeding time. We may also study how genes (pieces of DNA) affect the way the body responds to or handles the study medicine.
We’ll give 18 healthy volunteers, aged 18–45 years, 5 daily doses of aspirin (by mouth) and 1 dose of the study medicine (given by slow injection into a vein with their last dose of aspirin).
Participants will take up to 6 weeks to finish the study. They’ll make 2 outpatient visits, and stay on the ward for 7 nights.
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
13/LO/1663
Date of REC Opinion
15 Nov 2013
REC opinion
Favourable Opinion