The sponsor wants to investigate in this study how well the test medicine is taken up by the body when given orally (by mouth) as a tablet and solution, and as a solution for infusion (into a vein). The oral solution and solution for infusion 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, what it is broken down into, and how it leaves the body. The sponsor will also look at the safety and tolerability of the test medicine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
6
single oral dose of GLPG1972
a 15-minute IV infusion \[14C\]-GLPG1972
single oral dose of \[14C\]-GLPG1972
Quotient Sciences Limited
Nottingham, United Kingdom
Change of total radioactivity excreted in urine and feces combined (Period 2)
To assess the mass balance, using \[14C\]-GLPG1972
Time frame: From Day 1 pre-dose up to Day 10
Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2)
To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
Cmax of GLPG1972 (Period 2)
To assess the PK of GLPG1972 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 (Period 2)
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
AUC of GLPG1972 (Period 2)
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 10
Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2)
To characterize the elimination pathways and metabolite profile of GLPG1972
Time frame: From Day 1 pre-dose up to Day 7
Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
IV Cmax of total radioactivity (Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
IV AUC of [14C]-GLPG1972 MT (Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
IV AUC of total radioactivity (Period 1)
To assess the PK of GLPG1972 and its main metabolites in plasma
Time frame: From Day 1 pre-dose up to Day 4
The number of incidents of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs) and TEAEs leading to discontinuations (Period 1 and Period 2)
To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2)
Time frame: From Day 1 through study completion, an average of 2 months
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