The sponsor wants to investigate how well the test medicine is taken up by the body when given orally (by mouth) as a tablet or capsule and as a solution for infusion (into a vein). The capsule and the solution will be radiolabelled. 'Radiolabelled' means that the test medicine has a radioactive component which helps us to track where the test medicine is in the body.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
8
a single oral dose of GLPG1690
a 15-minute IV infusion \[14C\]-GLPG1690
single oral dose of \[14C\]-GLPG1690
Quotient Sciences Limited
Ruddington, United Kingdom
Change of total radioactivity excreted in urine and feces combined (µg) from baseline at Day 10 (Part 2)
To assess the mass balance using \[14C\]-GLPG1690.
Time frame: From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of total radioactivity (Part 2).
To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of GLPG1690 (Part 2).
To assess the pharmacokinetics (PK) of GLPG1690 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of total radioactivity (Part 2).
To assess the PK of GLPG1690 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
Area under the plasma concentration-time curve (AUC) of GLPG1690 (Part 2).
To assess the PK of GLPG1690 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
Change in amount of [14C] GLPG1690 excreted in urine and feces combined (µg) from baseline at Day 7 (Part 2).
To better characterize the elimination pathways and metabolite profile of GLPG1690
Time frame: From Day 1 pre-dose up to Day 7
Intravenous (IV) maximum observed plasma concentration (Cmax) of [14C]-GLPG1690 microtracer (MT) (Part 1).
To assess the PK of GLPG1690 and its main metabolites in plasma.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From Day 1 pre-dose up to Day 4
Intravenous (IV) maximum observed plasma concentration (Cmax) of total radioactivity (Part 1).
To assess the PK of GLPG1690 and its main metabolites in plasma.
Time frame: From Day 1 pre-dose up to Day 4
IV Area under the plasma concentration-time curve (AUC) of [14C]-GLPG1690 microtracer (MT) (Part 1).
To assess the PK of GLPG1690 and its main metabolites in plasma.
Time frame: From Day 1 pre-dose up to Day 4
IV Area under the plasma concentration-time curve (AUC) of total radioactivity(Part 1).
To assess the PK of GLPG1690 and its main metabolites in plasma.
Time frame: From Day 1 pre-dose up to Day 4
Safety and tolerability of GLPG1690, assessed by the number of subjects with adverse events (AEs) (Part 1 and Part 2).
To evaluate the safety and tolerability of GLPG1690 (in Part 1 and Part 2).
Time frame: From screening through study completion, an average of 2 months