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| ID | Type | Description | Link |
|---|---|---|---|
| 2020-004550-29 | EudraCT Number |
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A study in healthy male volunteers to assess how the radiolabelled test medicine is taken up and broken down by the body when given by short infusion into a vein and when given by the mouth in the form of a capsule or tablet.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GLPG1205 oral and [14C]-GLPG1205 IV | Experimental | Single oral dose of GLPG1205 followed by [14C]-GLPG1205 solution for infusion |
|
| [14C]-GLPG1205 capsule | Experimental | Single oral dose of GLPG1205 as solid formulation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG1205 film-coated tablets | Drug | Single oral dose of GLPG1205 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Absolute oral bioavailability (F) (%) | To determine the absolute bioavailability of an oral dose of GLPG1205 relative to an intravenous (i.v.) microtracer dose of [14C]-GLPG1205 | Between Day 1 and Day 22 |
| Recovery of total radioactivity in urine and feces measured as amount of [14C]-GLPG1205 excreted as percentage of the administered dose (Ae%) | To assess the mass balance recovery after a single oral dose of [14C]-GLPG1205 | Between Day 1 and Day 22 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Tankisheva, MD | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Nottingham | NG11 6JS | United Kingdom |
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| ID | Term |
|---|---|
| C000722907 | GLPG1205 |
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| [14C]-GLPG1205 solution for infusion |
| Drug |
A 15-minute IV infusion of [14C]-GLPG1205 |
|
| GLPG1205 capsules | Drug | Single oral dose of GLPG1205 as solid formulation |
|