Pharmacokinetics of BMS-986177 in Healthy Volunteers (QCL118141)
Research type
Research Study
Full title
A Study to Evaluate the Pharmacokinetics of BMS-986177 from a SDD Suspension and SDD Granule Capsule Formulation in Healthy Participants
IRAS ID
230343
Contact name
Nand Singh
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-001955-30
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
The Sponsor is developing a new medicine, BMS-986177, for the potential treatment of thrombosis which is the formation of a blood clot inside a blood vessel. Blood clots can obstruct the flow of blood through the circulatory system and are the primary cause of heart attacks and a major cause of stroke.
The new medicine 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 medicine is also not associated with significant bleeding it is an attractive new option for the treatment of thrombosis.
The study is designed to assess how 2 formulations (recipes) of the medicine are taken up by the body. The study will also investigate how 1 formulation of the medicine is taken up by the body when given with food. One of the doses will be given as a liquid to drink after fasting, one of the doses will be given as a capsule after fasting and one of the doses will be given as a capsule after eating a high fat breakfast.
The study will consist of 1 group of 14 volunteers. Each volunteer will receive 3 single doses of the medicine, by mouth. There will be a minimum of 4 days between each dose and volunteers will remain within the clinical unit between each dose.
REC name
London - London Bridge Research Ethics Committee
REC reference
17/LO/1804
Date of REC Opinion
31 Oct 2017
REC opinion
Favourable Opinion