Absolute Bioavailability of BMS-986165 in Healthy Male Participants
Research type
Research Study
Full title
Study to Evaluate the Absolute Bioavailability of BMS-986165 Tablet in Healthy Male Participants
IRAS ID
253098
Contact name
Head of Global Clinical Trial Submission Unit
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2018-003134-33
Duration of Study in the UK
0 years, 1 months, 0 days
Research summary
The Sponsor Bristol-Myers Squibb (BMS) is developing the test medicine, BMS-986165, for the potential treatment of the moderate-to-severe immune disorders psoriasis (red, flaky, crusty patches of skin covered with silvery scales), lupus (a long-term condition causing inflammation to the joints, skin and other organs), lupus nephritis (inflammation of the kidney that is caused by lupus), psoriatic arthritis (a type of arthritis associated with psoriasis, typically causing swollen, stiff and painful joints) and Crohn’s disease (inflammation of the digestive tract).
The study will try to identify the absolute bioavailability of BMS-986165 i.e. 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.
The study will consist of a single period with two treatments in up to 8 healthy male volunteers. Volunteers will be administered a 12 mg oral tablet of BMS-986165 after an overnight fast, followed by a very low intravenous dose (slow injection directly into the vein) of stable isotope labelled (non-radioactive) test medicine [13C2, 15N3]-BMS-986165 1 hour and 45 minutes after the oral dose. Blood samples will be collected for up to 72 hours (3 days) after oral dosing to measure the amount of BMS-986165 from the oral tablet in comparison to the amount of BMS-986205 from the intravenous dose. The intravenous dose of the test medicine can be measured separately from the oral due to the non-radioactive isotope label.
Volunteers will be confined to the clinical unit for 5 days.
REC name
Wales REC 2
REC reference
18/WA/0339
Date of REC Opinion
19 Nov 2018
REC opinion
Further Information Favourable Opinion