Phase 1 PK, ADME and IVMT study in healthy males (QSC203894)
Research type
Research Study
Full title
A Phase 1, open-label study to investigate the pharmacokinetics and metabolism of GLPG1205 in healthy male subjects following single intravenous [14C]-GLPG1205 microtracer and single oral [14C]-GLPG1205 administration.
IRAS ID
290194
Contact name
Ekaterina Tankisheva
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2020-004550-29
Duration of Study in the UK
0 years, 2 months, 3 days
Research summary
Summary of Research
The Sponsor is developing the test medicine, GLPG1205, for the potential treatment of 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 GLPG1205 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 12 healthy male volunteers (6 volunteers per part). In Part 1, 6 volunteers will receive a single dose of GLPG1205 film-coated tablets to swallow, followed 3.75 hours later by a 15 minute infusion of [14C]-GLPG1205 solution into a vein. In part 2, a different group of 6 volunteers will receive a single 100 mg oral dose, as a capsule containing a mix of GLPG1205 and [14C]-GLPG1205.
Summary of Results
Given that this is a Phase I trial, no lay summary of results has been provided for reasons of commercial confidentiality.
REC name
Wales REC 2
REC reference
20/WA/0303
Date of REC Opinion
26 Nov 2020
REC opinion
Further Information Favourable Opinion