Bioavailability of BMS-986141 (QCL117808)
Research type
Research Study
Full title
A Randomized Study to Evaluate the Bioavailability of BMS-986141 from a Citric-acid Co-crystal Tablet Formulation Relative to the SDD Reference Tablet in Healthy Participants
IRAS ID
216285
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-001031-13
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 21 days
Research summary
The Sponsor are developing the study drug for the potential treatment of atherothrombotic diseases. These diseases are caused by the build-up of fatty deposits inside the arteries (known as atherosclerosis) and an increased risk of blood clots. If a blood clot forms in a blood vessel, the blood flow to an organ or an area of the body may be cut off. If the blood supply is cut off the cells supplied by the blood vessel will die. If this happens to a vessel in the brain it can result in a stroke.
The study drug plays a part in the later stages of how the body form a blood clot. The study drug may be able to reduce the formation of a blood clot, lowering the risk of damage due to a lack of blood supply. As the drug works in the later stages of the blood clotting process, it does not completely block how the body forms a clot, resulting in a reduced risk of bleeding compared to other drugs which act earlier in the process.
The study is designed to assess how a new form of the study drug is taken up by the body compared to an existing form. The study will also investigate how the new form of study drug is taken up by the body when given with or without food. The study will consist of 1 cohort of 16 volunteers. Each volunteer will receive 4 single doses of the study drug, by mouth. Each dose will either be 8 mg or 48 mg (up to 6 tablets). One of the doses will be given after a high-fat breakfast. There will be a minimum of 7 days between each dose and volunteers will remain within the clinical between each dose.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0862
Date of REC Opinion
23 Jan 2017
REC opinion
Further Information Favourable Opinion