Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001305-25 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1972 oral and [14C]-GLPG1972 IV | Experimental | GLPG1972 film-coated tablet followed by [14C]-GLPG1972 solution for infusion |
|
| [14C]-GLPG1972 oral solution | Experimental | [14C]-GLPG1972 oral solution |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1972 film-coated tablets | Drug | single oral dose of GLPG1972 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change of total radioactivity excreted in urine and feces combined (Period 2) | To assess the mass balance, using [14C]-GLPG1972 | 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 | 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 | 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 | 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 | 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 | From Day 1 pre-dose up to Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Intravenous (IV) Cmax of [14C]-GLPG1972 microtracer (MT)(Period 1) | To assess the PK of GLPG1972 and its main metabolites in plasma | From Day 1 pre-dose up to Day 4 |
| IV Cmax of total radioactivity (Period 1) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Angela de Haas-Amatsaleh, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Limited | Nottingham | NG11 6JS | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| [14C]-GLPG1972 solution for infusion |
| Drug |
a 15-minute IV infusion [14C]-GLPG1972 |
|
| [14C]-GLPG1972 oral solution | Drug | single oral dose of [14C]-GLPG1972 |
|
To assess the PK of GLPG1972 and its main metabolites in plasma
| 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 | 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 | 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) | From Day 1 through study completion, an average of 2 months |