Does ethinicity affect blood levels, safety and effects of DS-1040b?v1
Research type
Research Study
Full title
A Phase I, Open-Label, Parallel-Group Study to Evaluate the Effect of Ethnicity on the Pharmacokinetics, Pharmacodynamics and Safety of a DS-1040b IV Infusion Administered to Healthy Male Subjects. HMR code: 15-015
IRAS ID
192560
Contact name
Frans Van Den Berg
Contact email
Sponsor organisation
Daiichi Sankyo Development Ltd
Eudract number
2015-003470-32
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
The study medicine (DS-1040b) is an experimental treatment to reduce the effects of a stroke in the brain, and the effects of other conditions caused by blood clots in veins. During a stroke, blood clots block the blood flow to the brain, and the affected areas of the brain stop working. Blood clots in veins in other parts of the body can also cause swelling and pain in the legs, shortness of breath, or coughing blood.
Patients with stroke or other clotting conditions are usually treated with medicines that dissolve blood clots, prevent clotting, or make 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.
If this and future studies are successful, the study medicine would be a useful treatment for patients in many countries. But first, we need to find out whether the safety, blood levels and effects of the study medicine vary among ethnic groups. So, we’re doing this study in healthy Japanese, Korean, Chinese and Caucasian people, to compare their results.
We’ll give 48 healthy volunteers (12 from each ethnicity), aged 18−60 years, a single dose of 20 mg of the study medicine by slow injection into a vein in the arm. Participants will take up to 6 weeks to finish the study. They’ll have 1 study session, make 4 outpatient visits, and stay on the ward for 4 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
Scotland A: Adults with Incapacity only
REC reference
15/SS/0199
Date of REC Opinion
20 Jan 2016
REC opinion
Further Information Favourable Opinion