Bioavailability Study of BMS-626529 in Healthy Subjects (QCL117632)
Research type
Research Study
Full title
Study of the Absolute Bioavailability of BMS-626529 in Healthy Subjects Following Oral Dosing of BMS-663068 and Intravenous Dosing of BMS-626529
IRAS ID
197609
Contact name
GCT-SU Representative
Contact email
Eudract number
2015-005030-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 2 days
Research summary
The Sponsor is developing BMS-663068 as a drug that is inactive until it is absorbed into the body and converted to BMS-626529. This study drug is being developed as an antiretroviral agent for the treatment of Human Immunodeficiency Virus (HIV)-1. HIV is a virus that attacks the immune system, weakening its ability to fight infections and disease. It is transmitted when an individual comes into direct contact with bodily fluids of a HIV-positive person. HIV can be split into two forms; HIV-1 and HIV-2. HIV-1 is the predominant virus worldwide and is the condition that most people are referring to when they talk about HIV. Antiretroviral interventions prevent any further damage to the immune system by attenuating the spread and replication of the virus. The study drug is an antiretroviral agent that has a novel mode of action via blockade of the first steps of HIV infection.
The study will try to identify how much BMS-626529 (converted from the administered dose of BMS-663068 tablet) will circulate in the blood when it has been given orally compared to when stable isotope labelled [13C6]-BMS-626529 is given intravenously.
The study will consist of a single period with two treatment regimens in up to 8 healthy male subjects. Subjects will be administered an oral dose of BMS-663068 after an overnight fast, followed by a intravenous dose of stable isotope labelled [13C6]-BMS-626529. Blood will be collected for up to 72 hours after study drug administration for determination of the concentration of BMS-626529 from BMS-663068 in the circulation, in comparison to the amount of stable isotope labelled [13C6]-BMS-626529 from intravenous infusion. Subjects will we confined to the clinical facility during this time and will be discharged after all blood samples have been collected. A follow up phone call will take place between Day 7 and Day 10 post-dose.
REC name
HSC REC B
REC reference
16/NI/0014
Date of REC Opinion
25 Feb 2016
REC opinion
Further Information Favourable Opinion