* Evaluation of mass balance and absolute bioavailability of GLPG3667 (QSC206282)
Research type
Research Study
Full title
An open-label study in healthy male subjects to investigate the metabolism and excretion pathways of GLPG3667 following a single oral dose of [14C]-GLPG3667 and to determine the absolute bioavailability relative to an intravenous [14C]-GLPG3667 microtracer
IRAS ID
1004852
Contact name
Golnar Karimiam
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2021-006730-39
Clinicaltrials.gov Identifier
Research summary
The Sponsor is developing the test medicine, GLPG3667, to treat inflammatory and autoimmune conditions. The test medicine (GLPG3667) is thought to work by inhibiting a pathway within the body which promotes improper activation of the immune system and therefore, inflammation in these conditions. \n\nThis two period healthy volunteer study will try to identify the how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by mouth in the form of a capsule, as well as the safety and tolerability of the test medicine. This is not the first time this test medicine has been given to people. \n\nThis study will take place at one non-NHS site, enrolling up to 6 male volunteers aged between 30-64.\n\nIn Period 1, up to 6 volunteers will receive a single oral dose of GLPG3667 75mg fed followed by a very small radiolabelled intravenous micro dose (100µg (micrograms)) of same test medicine. In Period 2, up to 6 volunteers will receive a single oral dose of radiolabelled GLPG3667 75mg fed. \n\nVolunteers will reside at the clinical unit from Day -1 of Period 1 and will be discharged at the latest on Day 10 of Period 2. Volunteers will receive a follow up phone call on 11-17 days post final dose.\n\nVolunteer’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and for their safety. \n\nVolunteers are expected to be involved in this study for approximately 7 weeks from screening to the follow up contact.
REC name
London - Chelsea Research Ethics Committee
REC reference
22/FT/0030
Date of REC Opinion
4 Apr 2022
REC opinion
Further Information Favourable Opinion