Safety, blood levels & effects of DS1040 alone or with clopidogrel, v1
Research type
Research Study
Full title
A Phase 1, open-label, two-period, fixed-sequence study to evaluate the safety and tolerability of DS-1040b IV infusion coadministered with clopidogrel in healthy subjects. HMR code (15-014)
IRAS ID
186754
Contact name
Frans van den Berg
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2015-003018-26
Duration of Study in the UK
1 years, 0 months, 0 days
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, or medicines that prevent the blood clotting, such as clopidogrel (also known as Plavix®). 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 clopidogrel. So, we need to make sure that it’s safe to take the study medicine with clopidogrel. We aim to find out the study medicine’s side effects, the blood levels of the study medicine and clopidogrel when taken separately or together, and their effects on substances linked to blood clotting. We’ll study how long blood takes to clot (bleeding time), when the study medicine and clopidogrel are taken separately or together. That’s because clopidogrel, and possibly the study medicine, increase bleeding time. We may also study genes (pieces of DNA) linked to stroke, and how genes affect the way the body responds to or handles the study medicine.
We’ll give 24 healthy volunteers, aged 18–60 years, 6 daily doses of clopidogrel (by mouth). We’ll also give 2 doses of the study medicine (given by slow injection into a vein) – 1 dose alone, and 1 with their last dose of clopidogrel.
Participants will take up to 8 weeks to finish the study. They’ll have 2 study sessions, make 6 outpatient visits, and stay on the ward for 13 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 - Brent Research Ethics Committee
REC reference
15/LO/1301
Date of REC Opinion
16 Sep 2015
REC opinion
Further Information Favourable Opinion