Absolute Bioavailability of BMS-986205 Tablet (QCL118212)
Research type
Research Study
Full title
A Study to Evaluate the Absolute Bioavailability of BMS-986205 Tablet Formulation
IRAS ID
236177
Contact name
Head of Global Clinical trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2017-003100-51
Duration of Study in the UK
0 years, 1 months, 22 days
Research summary
The Sponsor Bristol-Myers Squibb (BMS) is developing the test medicine (BMS-986205) for the potential treatment of advanced tumours (cancer).\n\nThe test medicine works by blocking an enzyme in the body which stops the immune system from working properly in patients with cancer. This enzyme may cause tumours (clusters of cancer cells) to grow more quickly and shorten patient survival time in most cancers. By blocking this enzyme in patients with cancer, the patient should have better responses to treatment and greater survival rates, especially when used in combination with other cancer medications.\n\nThe purpose of the study is to determine how much of the test medicine is taken up by the body when dosed once by mouth compared to when dosed once by injection directly into the vein.\n\nThe study will consist of a single period with two treatments in up to 8 healthy male and female subjects who are unable to have children. Subjects will be administered a 100 mg oral dose of BMS-986205 after an overnight fast, followed by a very low intravenous dose (slow injection directly into the vein) of a stable isotope labelled (non-radioactive) [13C]BMS-986205 2 hours after oral dosing. Blood will be collected for up to 336 hours (14 days) after dosing to measure the amount of BMS-986205 from the oral tablet in comparison to the amount of BMS-986205 from the intravenous dose. Subjects will be confined to the clinical facility during this time.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0627
Date of REC Opinion
3 Jan 2018
REC opinion
Further Information Favourable Opinion