2 Part study evaluating bioavailability of BMS-626529 (117540)
Research type
Research Study
Full title
A Two-Part Study to Evaluate the Bioavailability of BMS-626529 Administered as Prodrug BMS-663068 from Prototype Low-Dose Extended-Release Tablets (Part 1) and Prototype Multi Particulate Formulations (Part 2) Relative to the 600 mg Extended Release Tablet in Healthy Subjects
IRAS ID
181390
Contact name
Valerie Perpette
Contact email
Sponsor organisation
Bristol-Myers Squibb Research and Development
Eudract number
2015-001921-17
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 2 months, 9 days
Research summary
The Sponsor is developing the study drug, BMS-663068, as a potential treatment for patients living with Human Immunodeficiency Virus Type-1 (HIV-1).
The study will try to identify how different formulation variables of the study drug are taken up by the body. The study will also provide additional safety and tolerability of the study drug formulations in healthy male and female subjects.
The study will consist of 2 parts involving up to 28 healthy male and female subjects. In each part, subjects will receive a single 600milligram (mg) dose of an extended release tablet formulation of the study drug as a reference product. In Part 1, up to 14 subjects will receive up to 5 doses of different low dose formulations of the study drug, plus the reference product. The dose of each formulation will be 600mg. In Part 2, up to 14 subjects will receive up to 4 doses of multi-particulate formulation of the study drug plus the reference product.
REC name
HSC REC A
REC reference
15/NI/0124
Date of REC Opinion
21 Jul 2015
REC opinion
Further Information Favourable Opinion