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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-000711-23 | 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 tablet and an oral solution.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Absolute Bioavailability - Period 1 | Experimental | Participants will receive GLPG3970 under fasted conditions followed by an intravenous (i.v.) microtracer microdose of [14C]GLPG3970 on Day 1. |
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| Mass Balance - Period 2 | Experimental | Participants will receive [14C]GLPG397 under fasted conditions on Day 1. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GLPG3970 film-coated tablet | Drug | Participants will receive a single oral dose of GLPG3970. |
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| Measure | Description | Time Frame |
|---|---|---|
| Absolute oral bioavailability (F [%]) of GLPG3970 | From Day 1 pre-dose until Day 4 in Period 1 | |
| Recovery of total radioactivity excreted in urine expressed as a percentage of the administered dose (Ae%). | From Day 1 pre-dose until Day 8 in Period 2 | |
| Recovery of total radioactivity excreted in feces expressed as a percentage of the administered dose (Ae%). | From Day 1 pre-dose until Day 8 in Period 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of treatment-emergent adverse events (TEAEs), treatment-emergent serious adverse events (SAEs), and TEAEs leading to treatment discontinuations. | From Day 1 through study completion, an average of 1 month |
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Inclusion Criteria:
This list only contains the key inclusion criteria.
Exclusion Criteria:
This list only contains the key exclusion criteria.
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| Name | Affiliation | Role |
|---|---|---|
| Ekaterina Tankisheva | Lakefront Biotherapeutics NV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Ltd | Nottingham | NG11 6JS | United Kingdom |
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| [14C]GLPG3970 solution for infusion | Drug | Participants will receive an i.v. microtracer microdose. |
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| [14]GLPG3970 oral solution | Drug | Participants will receive a single oral dose [14C]GLPG3970. |
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