Phase 1 PK, ADME and IVMT study in healthy males (QSC200843)
Research type
Research Study
Full title
A Phase 1, open-label, single-center study to investigate the pharmacokinetics and metabolism of GLPG1690 in healthy male subjects following single intravenous GLPG1690 microtracer and oral [14C]-GLPG1690 administrations.
IRAS ID
250409
Contact name
Paul Ford
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2018-001354-99
Duration of Study in the UK
0 years, 1 months, 10 days
Research summary
The Sponsor is developing the test medicine, GLPG1690, for the potential treatment of lung diseases, such as idiopathic pulmonary fibrosis (IPF). IPF is a condition in which the lungs become scarred and breathing becomes increasingly difficult. It is currently unclear what causes it, but it usually affects people around 70-75 years of age and is rare in people under 50.
The study will use radiolabelled GLPG1690 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 GLPG1690 tablets by mouth followed by a 15 minute infusion of [14C]-GLPG1690 solution into a vein. In part 2, the same group of 6 volunteers will receive a single dose of [14C]-GLPG1690 capsules by mouth.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
18/LO/1857
Date of REC Opinion
1 Nov 2018
REC opinion
Favourable Opinion