* Evaluation of mass balance and absolute bioavailability of GLPG3970
Research type
Research Study
Full title
A Phase 1, open-label study to investigate the pharmacokinetics and metabolism of GLPG3970 in healthy male subjects following a single oral dose of GLPG3970 relative to an intravenous [14C]GLPG3970 microtracer and single oral [14C]GLPG3970 administration.
IRAS ID
295496
Contact name
Ekaterina Tankisheva
Contact email
Sponsor organisation
Galapagos NV
Eudract number
2021-000711-23
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 11 days
Research summary
The Sponsor is developing the test medicine, GLPG3970, for the potential treatment of inflammatory disorders and defects of the immune system.
The study will try to identify and compare how the test medicine is taken up by the body when given orally and when given by an injection into the vein. The study will also try to identify how the test medicine is broken down and removed by the body. The test medicine will be given in both a radiolabeled form and a non-radiolabeled form. Radiolabeled means that the test medicine has a radioactive component which helps to track where the test medicine is in the body.
The study will consist of 2 study periods (conducted sequentially) involving 6 healthy male volunteers. Volunteers will be admitted to the clinic on Day -1. On Day 1 following an overnight fast of at least 10 hours, volunteers will receive an oral dose of GLPG3970, followed 75 minutes later by a radiolabeled intravenous dose (into a vein) as a 15 minute infusion. Following a washout period of at least 7 days, volunteers will receive a single oral dose of radiolabeled GLPG3970 in the form of a solution in the fasted state. Volunteers will be discharged on Day 8 of Period 2 (Day 15), however if the radioactive criteria has not been met, volunteers stay may be extended to Day 10 of Period 2 (Day 17). Volunteers may be asked to collect urine and/or feces at home following Day 17 if required.
A follow-up phone call will take place approximately 13 days after the final dose of the test medicine to monitor volunteer safety and wellbeing.
REC name
London - London Bridge Research Ethics Committee
REC reference
21/FT/0045
Date of REC Opinion
15 Apr 2021
REC opinion
Further Information Favourable Opinion