Healthy
Conditions
Brief summary
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.
Interventions
DRUG[14C]-GLPG1972 solution for infusion
a 15-minute IV infusion \[14C\]-GLPG1972
DRUGGLPG1972 film-coated tablets
single oral dose of GLPG1972
DRUG[14C]-GLPG1972 oral solution
single oral dose of \[14C\]-GLPG1972
Sponsors
Galapagos NV
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Male between 30-64 years of age (extremes included), on the date of signing the Informed Consent Form (ICF). * A body mass index (BMI) between 18.0-32.0 kg/m2, inclusive. * Judged to be in good health by the investigator based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests. Clinical laboratory safety test results must be within the reference ranges or considered not clinically significant in the opinion of the investigator. * Having a regular daily defecation pattern (i.e. 1 to 3 times per day).
Exclusion criteria
* Known hypersensitivity to IMP ingredients or history of a significant allergic reaction to IMP ingredients as determined by the investigator, and/or known sensitivity to IMP or the excipients (e.g. lactose). Hayfever is allowed unless active. * History of or a current immunosuppressive condition (e.g. human immunodeficiency virus \[HIV\] infection). * Having any illness, judged by the investigator as clinically significant, in the 3 months prior to first investigational medicinal product (IMP) administration. * Participation in a study with 14C-radiolabeled drug in the last 12 months prior to first IMP administration. * Radiation exposure, including that from the present study, excluding background radiation but including diagnostic X-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 millisievert (mSv) in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, can participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in amount of [14C]-GLPG1972 excreted in urine and feces combined (μg) from baseline at Day 7 (Part 2) | From Day 1 pre-dose up to Day 7 | To characterize the elimination pathways and metabolite profile of GLPG1972 |
| Change of total radioactivity excreted in urine and feces combined (Period 2) | From Day 1 pre-dose up to Day 10 | To assess the mass balance, using \[14C\]-GLPG1972 |
| Maximum observed plasma concentration (Cmax) of total radioactivity (Period 2) | From Day 1 pre-dose up to Day 10 | To assess the pharmacokinetics (PK) of GLPG1972 and its main metabolites in plasma |
| Cmax of GLPG1972 (Period 2) | From Day 1 pre-dose up to Day 10 | To assess the PK of GLPG1972 and its main metabolites in plasma |
| Area under the plasma concentration-time curve (AUC) of total radioactivity (Period 2) | From Day 1 pre-dose up to Day 10 | To assess the PK of GLPG1972 and its main metabolites in plasma |
| AUC of GLPG1972 (Period 2) | From Day 1 pre-dose up to Day 10 | To assess the PK of GLPG1972 and its main metabolites in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| IV Cmax of total radioactivity (Period 1) | From Day 1 pre-dose up to Day 4 | To assess the PK of GLPG1972 and its main metabolites in plasma |
| IV AUC of [14C]-GLPG1972 MT (Period 1) | From Day 1 pre-dose up to Day 4 | To assess the PK of GLPG1972 and its main metabolites in plasma |
| IV AUC of total radioactivity (Period 1) | From Day 1 pre-dose up to Day 4 | To assess the PK of GLPG1972 and its main metabolites in plasma |
| 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) | From Day 1 through study completion, an average of 2 months | To evaluate the safety and tolerability of GLPG1972 (Period 1 and Period 2) |
| Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1) | From Day 1 pre-dose up to Day 4 | To assess the PK of GLPG1972 and its main metabolites in plasma |
Countries
United Kingdom
Outcome results
None listed