Bioavailability and Food Effect Study of GLPG1972 (QSC202736)
Research type
Research Study
Full title
A randomized, open-label, four-period, single-dose cross-over study in healthy male subjects to assess the relative bioavailability of two candidate tablet formulations versus the current tablet formulation of GLPG1972 and to assess the food effect of the tablet formulation selected for Phase 3 in Period 4.
IRAS ID
270977
Contact name
Angela de Haas-Amatsaleh
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2019-002144-25
Duration of Study in the UK
0 years, 2 months, 7 days
Research summary
The sponsor is developing the test medicine, GLPG1972, for the potential treatment of osteoarthritis (OA). Osteoarthritis is a condition that causes joints to become painful and stiff, and is the most common type of arthritis in the UK. In more severe cases it can stop people from carrying out everyday activities. The exact cause is not known, however osteoarthritis occurs when cartilage, a tough protective tissue on the ends of your bones, breaks down. It can affect anyone, although is more common in people over 50 years of age.
In this study, the sponsor wants to investigate two new tablet formulations (recipes) of the test medicine, and how they are taken up by the body in comparison to the current tablet formulation. The sponsor may then investigate the effect food has on one of the new tablet formulations.
The study will consist of 4 periods involving up to 18 healthy male volunteers. In Periods 1 to 3, the volunteers will receive one dose of each formulation after an overnight fast in a randomized manner. If it is decided that one of the new formulations should be progressed to Phase III, then the optional Period 4 will also take place. In Period 4 the volunteers will receive one dose of a previously dosed formulation under fed conditions.
REC name
London - Chelsea Research Ethics Committee
REC reference
19/LO/1424
Date of REC Opinion
8 Oct 2019
REC opinion
Further Information Favourable Opinion