Phase 1 PK, ADME and IVMT study in healthy males (QSC202010)
Research type
Research Study
Full title
A Phase 1, open-label, single-center study to investigate the pharmacokinetics and metabolism of GLPG1972 in healthy male subjects following single intravenous [14C]-GLPG1972 microtracer and single oral [14C]-GLPG1972 administration
IRAS ID
266889
Contact name
Somasekhara Menakuru
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2019-001305-25
Duration of Study in the UK
0 years, 1 months, 16 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 causes 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.
The study will use radiolabelled GLPG1972 to identify how the medicine is taken up, absorbed, processed and removed by the body. Radiolabelled means that the test medicine has a radioactive component which helps us to track where the drug is in the body. The type of radioactivity used, carbon 14, is naturally occurring radioactivity that will allow us to trace the study drug in the blood and assess how much is being taken up into/broken down in the body.
The study will consist of 2 parts involving up to 6 healthy male volunteers. In Part 1, up to 6 volunteers will receive a dose of GLPG1972 tablets by mouth followed by a 15 minute infusion of [14C]-GLPG1972 solution into a vein. In Part 2, the same group of 6 volunteers will receive a single dose of [14C]-GLPG1972 solution by mouth.
REC name
Wales REC 2
REC reference
19/WA/0207
Date of REC Opinion
30 Jul 2019
REC opinion
Further Information Favourable Opinion